An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease
Phase: PHASE3
Conditions: Alzheimer's Disease
Sponsor: H. Lundbeck A/S

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Page 1 of 82
Clinical Study Protocol
An open-label extension study to evaluate the long-term 
safety and tolerability of Lu AE58054 as adjunctive 
treatment to donepezil in patients with mild-moderate 
Alzheimer's disease
Idalopirdine (Lu AE58054)
Phase III
Study No.:
14861B
EudraCT/IND No.:
2013-000001-23/ 118,782
Sponsor:
H. Lundbeck A/S (Lundbeck)                                                                    
2500 Valby (Copenhagen), Denmark
Edition No.:
3.0 (including CSPA02)
(the version No. in the footer is the system version No.)
Date of edition:
16 June 2015
Edition history:
Edition 1.0 (original protocol), 09 September 2013
Edition 2.0 (including PA01 and CSPA01), 19 February 2014
This document is the property of H. Lundbeck A/S and H. Lundbeck A/S is the holder of any and all 
related intellectual property rights, including, but not limited to, copyrights.  This document is 
confidential.  It is not to be copied or distributed to other parties without prior written authorisation 
from H. Lundbeck A/S.

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Synopsis – Study 14861B
Sponsor
H. Lundbeck A/S 
Investigational Medicinal Product
Idalopirdine (Lu AE58054)
EudraCT/IND No.
2013-000001-23/ 118,782
Title of Study
An open-label extension study to evaluate the long-term safety and tolerability of Lu AE58054 as adjunctive 
treatment to donepezil in patients with mild-moderate Alzheimer's disease
Study Sites and Number of Patients Planned
Open-label treatment period (initial 28-week period):
Approximately 240 sites (hospitals and specialist centres) are planned in 30-35 countries.
Up to 1770 patients with mild-moderate Alzheimer's disease (AD), who have completed Visit 7 (Completion 
Visit) in one of the lead-in studies.
Open-label treatment period with memantine (substudy):
Approximately 70-90 sites are planned in 13 countries, hospital and specialist centres. Only certain sites within 
a country will be selected to participate and will depend primarily on the site’s potential eligible patient 
population.
Approximately 100 patients with Alzheimer’s disease, who have completed the open-label treatment period 
(initial 28-week period, i.e., Visit 6).  
Objectives
Open-label treatment period (initial 28-week period):
Primary objective:
To evaluate the long term safety and tolerability of idalopirdine as adjunctive therapy to donepezil in 
patients with mild-moderate AD.
Secondary objective:
To evaluate the disease development during long term treatment with idalopirdine as adjunctive therapy 
to donepezil.
Open-label treatment period with memantine (with memantine):
Primary objective:
To evaluate the safety and tolerability of concomitant treatment with idalopirdine, memantine and 
donepezil in patients with AD.
Secondary objective:
To evaluate the disease development during concomitant treatment with idalopirdine, memantine and 
donepezil in patients with AD.
Other objectives
To explore population pharmacokinetics

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Study Methodology
This is an interventional, multi-national, multi-site, open-label extension study in patients with mild to 
moderate AD who completed the 24-week "lead-in" double-blind, placebo controlled clinical studies 14861A 
and 14862A (from now on these studies will be referred to as “lead-in study” in the document). Investigators
will be informed about which treatment their patients received only after the last patient from their respective 
lead-in study has completed the extension study.
For sites not participating in the open-label treatment period with memantine (substudy), the study will 
include one period. For sites participating in the open-label treatment period with memantine (substudy), the 
study will include two consecutive periods:
Open-label treatment period (initial 28-week period): 28-weeks with idalopirdine 60 mg/day as 
adjunctive treatment to donepezil (10 mg/day). The dose of idalopirdine can be decreased to 30 mg/day if 
60 mg/day is not well tolerated in the opinion of the investigator during this 28-week period only. The 
Baseline Visit of this period (Baseline II) will be the same visit as Visit 7 (Completion Visit) in the lead-
in studies.
Open-label treatment period with memantine (substudy): 24-weeks with idalopirdine 60 mg/day (or 30 
mg/day) [continuation of dose used in open-label treatment period (initial 28-week period)] as adjunctive 
treatment to donepezil hydrochloride 10 mg/day and memantine (patient’s individualised maintenance 
dose, including a titration phase of up to 3 weeks). Memantine should be prescribed according to 
investigator's judgement and the initial dose may be changed at any time throughout the course of the 
study, if clinically indicated in the opinion of the investigator. The dose and dosing regimen of donepezil 
and idalopirdine in the 24-week period must remain fixed at that given in the open-label treatment period 
(initial 28-week period). The Baseline Visit of this period (Baseline III) will be the same visit as Visit 6 
in the open-label treatment period (initial 28-week period).
Patients completing the open-label treatment period (initial 28-week period) and who will not continue into 
the 24-week open-label treatment period with memantine (substudy) will enter a 4-week safety follow-up 
period. Thus the total study duration per patient from Baseline II to the end of the follow-up will be 
approximately 32 weeks.
Patients completing the two consecutive treatment periods will enter a 4-week safety follow-up period. Thus 
the total study duration per patient from Baseline II to the end of the follow-up will be approximately 56 
weeks.
The study design is presented in Panel 1 and the scheduled assessments are summarised in Panel 2 and Panel 
3.
An independent Data Monitoring Committee (DMC) will monitor the patients' safety according to the Data 
Monitoring Committee Charter.

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Target Patient Population
Open-label treatment period (initial 28-week period):
Major inclusion criteria
The patient has completed Visit 7 (Completion Visit) in the lead-in study.
Major exclusion criteria
The patient has a moderate or severe ongoing adverse event from the lead-in study considered a potential 
safety risk by the investigator.
The patient has been tested positive for hepatitis B surface antigen (HBsAg), or hepatitis C virus / antibodies 
(anti-HCV), AND had abnormal ALT, AST or bilirubin in the lead-in study.
The patient has been tested positive for hepatitis B surface antigen (HBsAg), or hepatitis C virus /antibodies 
(anti-HCV) for the first time within the last 6 months prior to the Completion Visit in the lead-in study.
The patient has one or more clinical laboratory test values outside the reference range, based on the latest 
available blood and urine sample results, available at the Completion Visit in the lead-in study, that are of 
potential risk to the patient’s safety, or the patient has according to the latest available blood sample:

a serum creatinine value >1.5 times the upper limit of the reference range, or
a serum total bilirubin value >1.5 times the upper limit of the reference range, or
a serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value >1.5 times the 
upper limit of the reference range.
Open-label treatment period with memantine (substudy):
Major inclusion criteria at Baseline III
The patient has completed Visit 6 (i.e., the open-label treatment period [initial 28-week period]).
The patient has a MMSE score at Visit 6 not greater than 19 in accordance with the memantine label/summary 
of product characteristics (SmPC).
The patient, according to the judgement of the investigator, requires initiation of treatment with memantine as 
per local label/SmPC/treatment guidelines.
Major exclusion criteria at Baseline III
The patient exhibits an increase in MMSE score by 3 points or more at Visit 6 from Baseline II.
The patient has a moderate or severe on-going adverse event from the open-label treatment period (initial 28-
week period) considered a potential safety risk by the investigator.
The patient has a previous history of testing positive for hepatitis B surface antigen (HBsAg), or hepatitis C 
virus / antibodies (anti-HCV) AND had abnormal ALT, AST or bilirubin during the open-label treatment 
period (initial 28-week period).
The patient has tested positive for hepatitis B surface antigen (HBsAg), or hepatitis C virus /antibodies (anti-
HCV) for the first time within the last 6 months prior to Visit 6 in the open-label treatment period (initial 28-
week period).
The patient has one or more clinical laboratory test values outside the reference range, based on the latest 
available blood and urine sample results during the open-label treatment period (initial 28-week period), that 
are of potential risk to the patient’s safety, or the patient has according to the latest available blood sample:

a serum creatinine value >1.5 times the upper limit of the reference range, or

a serum total bilirubin value >1.5 times the upper limit of the reference range, or
a serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value >2 times the upper 
limit of the reference range.

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Investigational Medicinal Product, Doses and Mode of Administration
Open-label treatment period (initial 28-week period):
Base treatment: 
Donepezil hydrochloride - 10 mg/day; once daily, tablets, for oral use.
Investigational Medicinal Product (IMP):
Idalopirdine - 60 mg/day (or 30 mg/day); once daily, encapsulated tablets, for oral use.
Open-label treatment period with memantine (substudy):
Base treatments: 
Donepezil hydrochloride - 10 mg/day; once daily, tablets, for oral use.
Memantine immediate-release (IR): 20 mg/day (recommended target dose) or patient’s individualised 
maintenance dose (including titration doses as applicable during an initial titration phase of up to 3 weeks); 
once daily or twice daily, tablets, for oral use. 
Memantine extended-release (XR): 28 mg/day (recommended target dose) or patient’s individualised 
maintenance dose (including titration doses as applicable during an initial titration phase of up to 3 weeks); 
once daily, capsules, for oral use.
Investigational Medicinal Product (IMP):
Idalopirdine - 60 mg/day (or 30 mg/day); once daily, encapsulated tablets, for oral use.
Memantine will not be supplied by Lundbeck, but should be prescribed according to approved SmPC/label by 
the investigator or another medically-qualified person.
Efficacy Assessments
Open-label treatment period (initial 28-week period):
Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog)
Alzheimer’s Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)
Alzheimer’s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL23) 
Neuropsychiatric Inventory (NPI) 
Mini Mental State Examination (MMSE)
Open- label treatment period with memantine (substudy):
Mini Mental State Examination (MMSE)
Pharmacoeconomic Assessments
Open-label treatment period (initial 28-week period):
Resource Utilisation in Dementia – Lite (RUD-Lite)
EQ-5D-3L
Dependence scale
Open-label treatment period with memantine (substudy):
Patient’s current living accommodation (question extracted from the Resource Utilisation in Dementia – Lite 
(RUD-Lite))
Dependence scale
Pharmacokinetic/Pharmacodynamic/Translational Medicine Assessments
Open-label treatment period with memantine (substudy):
Blood samples for drug plasma concentration analyses of idalopirdine and memantine will be drawn according 
to the schedule in Panel 3.

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Safety Assessments
Adverse events (AEs)
Clinical safety laboratory tests
Vital signs
Weight/Body Mass Index (BMI)
Electrocardiograms (ECGs)
Physical and neurological examinations
Columbia Suicide Severity Rating Scale (C-SSRS)
Endpoints
N/A
Statistical Methodology
The following analysis sets will be used to analyse and present data:
all-patients-treated set (APTS) – all patients who took at least one dose of IMP in the open-label treatment 
period (initial 28-week period).
all-patients-treated set 2 (APTS2) – all patients who took at least one dose of both IMP and memantine in the 
open-label treatment period with memantine (substudy).
All analyses in the open-label treatment period (initial 28-week period) will be based on the APTS, and all 
analyses in the open-label treatment period with memantine (substudy) will be based on APTS2.
Safety and efficacy assessments will be summarised descriptively. On an exploratory basis the development of 
efficacy assessments in the open-label treatment period (initial 28-week period) will be analysed using Mixed 
Models for Repeated Measurements (MMRM).
Data will be presented for each treatment period [open-label-treatment period (initial 28-week period) and 
open-label treatment period with memantine (substudy)] separately for all patients in total as well as by 
treatment group (placebo or idalopirdine all doses pooled) in the lead-in study, or by lead-in study, and 
treatment group in the lead-in study.
Sample Size Considerations
Open-label treatment period (initial 28-week period):
The study will include eligible patients who have completed Visit 7 (Completion Visit) of the lead-in studies. 
Assuming a completion rate of 85% and that approximately 85% of these are eligible and complete the 
extension study, this results in a total of approximately (3x310 + 3x280) x 85% x 85% ≈ 1280 patients 
completing this study.
Open-label treatment period with memantine (substudy):
With a sample size of n=100 the upper 1-sided 90% confidence limit for 0 to 10 AEs observed is:
Number of AEs 
observed
0
1
2
3
4
5
10
Upper 1-sided CI 
for AE incidence
2.3%
3.9%
5.3%
6.6%
7.9%
9.1%
15.0%
This is regarded as sufficient accuracy for evaluating safety and tolerability.

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Ethical Rationale for Study and Study Design
Patients will be fully informed about the study including the risks and benefits of his/her participation in the 
study.
The risks associated with this study are considered adequately elucidated in the non-clinical and clinical studies, 
well controlled by cautionary measures in the study design, and well balanced with the potential benefits of the 
treatment.
Since the study will enrol patients with dementia, special attention must be paid to the procedures for informed 
consent. Ample time must be given for explanation of the consequences of participation in the study. Detailed 
local procedures on the informed consent process for the patient (or, if applicable, the legal representative) and 
caregiver must fulfil GCP standards, be in accordance with the Declaration of Helsinki, and comply with 
national laws/Ethics Committees requirements.
An independent DMC will monitor the patients' safety according to the DMC Charter.
Open- label treatment period with memantine (substudy):
AD is a progressive neurodegenerative disease that is characterised by a steady decline in a patient’s cognition 
and function and an increase in behavioural problems. As patients advance into the moderate stage of AD there 
may be a need for additional therapy, such as the addition of memantine, to alleviate symptoms that can no 
longer be managed on the patient’s current therapy alone. Thus in a complex disease like AD, there is a strong 
medical need for alternative treatment options which include combining the different symptomatic treatments 
with diverse pharmacological modes of action. Concomitant treatment with the three compounds has not been 
studied in previous or on-going clinical trials. Consequently, it is considered ethical to evaluate the safety and 
tolerability of adding memantine treatment in patients participating in study 14861B, i.e., in patients who are 
already on a stable treatment of idalopirdine and donepezil and for whom memantine treatment is clinically 
indicated.
All patients participating in this study will receive idalopirdine, memantine and donepezil. The study period 
will allow inclusion of patients for whom the investigator believes that memantine treatment is warranted. 
Memantine will be prescribed according to the local label/SmPC/guidelines meaning that the dose of 
memantine can be adjusted, if clinically indicated in the opinion of the investigator. In addition, the patients 
will continue receiving idalopirdine and their donepezil base treatment. Consequently, no patient will be denied 
access to treatment.

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Panel 1
Study Design
4w
8w
12w
24w
Idalopirdine (30mg, 60mg) or PBO
+ donepezil
Placebo-controlled double-blind 
treatment period
24 weeks
Idalopirdine (10mg, 30mg) or PBO 
+ donepezil
Lead-in Studies
Open continuation of 14861B
Idalopirdine 60 mg (or 30 mg) + donepezil + memantine
4-week safety
follow- up
Baseline Visit for 
14861B study is
same as 14861A or 
14862A study Visit 7
14861A
14862A
Study 14861B
Open-label treatment period 
with Idalopirdine
28 weeks
Open-label treatment period 
with idalopirdine PLUS 
memantine add-on therapy 
24 weeks
Memantine initiation.
Baseline Visit for this 
study is same as 
14861B study 
Visit 6
Idalopirdine 60 mg (or 30 mg) 
+ donepezil
Memantine
titration
4w
8w
12w
20w
28w
Lu AE58054 (30mg, 60mg) or PBO + donepezil
Double-blind treatment period
24 weeks
Lu AE58054 (10mg, 30mg) or PBO + donepezil
Lead-in Studies
Study 14861B
Lu AE58054 60 mg (or 30 mg) + donepezil
4-week 
safety
follow-up
Baseline II (same as 
Lead-in study Visit 7)
14861A
28 weeks
14862A

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Panel 2
Study Procedures and Assessments [open-label treatment period (initial 
28-week period)]
Visit
Baseline 
IIa
Treatment Period
Completion/ 
Withdrawalb
Safety Follow-up c
Visit Number
1
2
3
4
5
6
7
Dayd/
End of Week
0
28/
4
56/
8
84/
12
140/
20
196/
28
224/
32
Visit Windowe (days 
relative to nominal visit)
7d
7d
7d
7d
7d
+ 7d
Screening/Baseline Procedures and Assessments
Signed informed consent

Demographics
f
Height
f
Medical history
f
Inclusion/exclusion criteria

Efficacy Assessments
MMSE
g

ADAS-Cog
g


ADCS-ADL23
g


ADCS-CGICh
g


NPI
g


Other Assessments
RUD Lite
g


EQ-5D-3L
g


Dependence scale
i


Safety Assessments
Adverse events
j





k
Blood and urine sampling 
for clinical safety 
laboratory tests 
g





Vital signs, weight, ECGs
g





C-SSRS
g





Examinations (physical, 
neurological)
g



Other Study Procedures
IMP and donepezill
hydrochloride dispensed





IMP and donepezill
hydrochloride returned 
accountability tracked






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Visit
Baseline 
IIa
Treatment Period
Completion/ 
Withdrawalb
Safety Follow-up c
Visit Number
1
2
3
4
5
6
7
Dayd/
End of Week
0
28/
4
56/
8
84/
12
140/
20
196/
28
224/
32
Visit Windowe (days 
relative to nominal visit)
7d
7d
7d
7d
7d
+ 7d
Screening/Baseline Procedures and Assessments
Recent and concomitant 
medication
j






Dispense Patient 
Identification card

Patient Identification card 
returned
m
Informed Consent Provided 
[open-label treatment 
period with memantine 
(substudy)]
n
a.
For the purposes of clarity, the Baseline Visit is called Baseline II Visit and this visit is the same as Visit 7 
(Completion Visit) in the lead-in study.
b.
This visit should take place as soon as possible after the patient withdraws from the study.
c.
Patients who complete the study and do not enter into the open-label treatment period with memantine
(substudy) will have a Safety Follow-up Visit which is at least 4 weeks (+ up to 7 days) after the last dose 
of IMP. Patients withdrawn will likewise be followed-up 4 weeks (+ up to 7 days) after withdrawal except 
for those who withdraw their consent. Patients who withdraw their consent should still have a safety 
follow-up, but the visit must only be recorded in the medical records.
d.
All assessments can be completed over a maximum of two consecutive days, in this case the first day 
should be considered as the visit day of the study. Note: If a visit takes place over two consecutive days the 
IMP should be dispensed on the second day, after all assessments have been performed. For visits other 
than the Baseline II visit, the visit window must allow for the previously dispensed IMP to last for both 
visit days.
e.
If the date of a patient visit does not conform to the study plan, subsequent visits should be planned to 
maintain the visit schedule relative to Baseline II. Number of days between 2 visits must not exceed the 
number of days for which IMP is provided in the wallet cards.
f.
Lead-in study screening visit (Visit 1) data transferred.
g.
Assessments and procedures conducted at Visit 7 (Completion Visit) of the lead-in study will be transferred 
and will not be repeated at the Baseline II Visit of this extension study.
h.
During evaluation the patient should be compared to Baseline I assessment of the lead-in study.
i.
Data will be transferred from Visit 7 (Completion Visit) of the lead-in study or entered manually to the 
eCRF if the scale has been administered for the first time at Visit 1 of the extension study. 
j.
On-going adverse events and Concomitant Medications at Visit 7 (Completion Visit) from the lead-in study 
are to be transferred to the eCRF.
k.
Only for adverse events on-going at Completion/Withdrawal Visit and new SAEs.
l.
As base treatment, donepezil hydrochloride 10 mg/day will be dispensed as wallet cards.
m.
Patient Identification Card should only be returned after the last dose of IMP has been taken, that is at the 
end of the treatment period.
n.
For patients who may be eligible to participate in the open-label treatment period with memantine
(substudy), it is suggested that the Informed Consent Form is provided. 

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Panel 3
Study Procedures and Assessments [open-label treatment with memantine
(substudy)]
Visit
Baseline 
IIIa
Treatment Period
Completion/  
Withdrawalb
Safety 
Follow-up c
Visit Number
6
8j
9
10
11
12
Day/d
End of Week
0
224/
32
252/
36
280/
40
364/
52
392/
56
Visit Windowe (days relative to 
nominal visit)
7d
7d
7d
7d
+ 7d
Screening/Baseline Procedures and 
Assessments
Signed informed consent

Demographics, height

Medical history

Inclusion/exclusion criteria

Efficacy Assessments
MMSE
f

Pharmacoeconomic Assessments
Patient’s current living 
accommodation (question extracted 
from the RUD-Lite) 
f


Dependence scale
f


Pharmacokinetic Assessments
Blood sampling for idalopirdine and 
memantine





Safety Assessments
Adverse events
f




g
Blood and urine sampling for clinical 
safety laboratory tests 
f




Vital signs, weight, ECGs
f




C-SSRS
f




Examinations (physical, neurological)
f


Other Study Procedures
IMP and donepezil hydrochloride 
dispensed. Memantine prescribed h




IMP, memantine and donepezil 
hydrochloride returned and 
accountability tracked h




Recent and concomitant medication
f




Dispense Patient Identification card

Patient Identification card returned
i
a.
The Baseline Visit for this study (Baseline III) is the same visit as Visit 6 (end of Week 28) for patients 
who complete the open-label treatment period (initial 28-week period).
b.
This visit should take place as soon as possible after the patient withdraws from the study.

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c.
Patients who complete the study will have a Safety Follow-up Visit which is at least 4 weeks (+ up to 7 
days) after the last dose of IMP. Patients withdrawn will likewise be followed-up 4 weeks (+ up to 7 days) 
after withdrawal except for those who withdraw their consent. Patients who withdraw their consent should 
still have a safety follow-up, but the visit must only be recorded in the medical records.
d.
All assessments can be completed over a maximum of two consecutive days, in this case the first day 
should be considered as the visit day of the study. Note: If a visit takes place over two consecutive days the 
IMP should be dispensed on the second day, after all assessments have been performed. For visits other 
than the Baseline Visit of this study, the visit window must allow for the previously dispensed IMP to last 
for both visit days.
e.
If the date of a patient visit does not conform to the study plan, subsequent visits should be planned to 
maintain the visit schedule relative to Baseline III of this study. Number of days between 2 visits must not 
exceed the number of days for which IMP is provided in the wallet cards.
f.
Assessments and procedures are the same as Visit 6 in the open-label treatment period (initial 28-week 
period).
g.
Only for adverse events on-going at Completion/Withdrawal of this study and new SAEs.
h.
Donepezil hydrochloride 10 mg/day will be dispensed as wallet cards. Memantine (titration doses plus 
patient’s individualised maintenance dose) will be prescribed by the investigator or another medically-
qualified person and the investigator should make sure that an adequate supply of memantine is prescribed 
to last between two visits (including visit windows). In addition to the return of IMP and donepezil 
hydrochloride, patient will be asked to bring used and unused memantine in original packaging to the visit 
for accountability purposes.
i.
Patient Identification Card should only be returned after the last dose of IMP has been taken, that is at the 
end of the treatment period.
j.
All patients entering the open-label treatment period with memantine (substudy) will perform Visit 8 right 
after Visit 6 [Visit 7 is the Safety Follow-up visit only for patients who do not continue into the open-label 
treatment period with memantine (substudy)].

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Table of Contents
List of Panels.........................................................................................................................................17
List of Abbreviations and Definitions of Terms ................................................................................18
1
Introduction................................................................................................................................20
1.1
Background........................................................................................................................20
1.1.1
Overview............................................................................................................20
1.1.2
Non-clinical Data ...............................................................................................20
1.1.3
Clinical Data.......................................................................................................21
1.1.3.1
Pharmacokinetics and Pharmacodynamics......................................22
1.1.3.2
Efficacy............................................................................................22
1.1.3.3
Safety...............................................................................................22
1.2
Rationale for the Study......................................................................................................23
2
Objectives....................................................................................................................................24
2.1
Primary Objective..............................................................................................................24
2.2
Secondary Objective..........................................................................................................24
2.3
Other Objectives................................................................................................................24
3
Study Design...............................................................................................................................24
3.1
Overview of the Study Design...........................................................................................24
3.2
Rationale for the Study Design..........................................................................................26
4
Ethics...........................................................................................................................................27
4.1
Ethical Rationale................................................................................................................27
4.2
Informed Consent ..............................................................................................................28
4.3
Patient Contact Arrangements ...........................................................................................29
4.4
Personal Data Protection....................................................................................................29
4.5
Independent Ethics Committees (IECs) and Institutional Review Boards (IRBs) ............30
4.6
Regulatory Approval/Notification Requirements..............................................................30
5
Study Population........................................................................................................................30
5.1
Numbers of Patients and Sites ...........................................................................................30
5.2
Patient Recruitment ...........................................................................................................30
5.3
Selection Criteria ...............................................................................................................31
5.4
Withdrawal Criteria ...........................................................................................................35
6
Investigational Medicinal Products..........................................................................................36
6.1
Treatment Regimen ...........................................................................................................36
6.2
IMPs, Formulations, and Strengths....................................................................................38
6.3
Manufacturing, Packaging, Labelling, and Storage of IMP ..............................................39
6.4
Dispensing of IMP.............................................................................................................39
6.5
Method of Assigning Patients to Treatment ......................................................................40
6.6
IMP Accountability ...........................................................................................................40
6.7
Post-study Access to IMP..................................................................................................41
7
Concomitant Medication...........................................................................................................41
8
Study Visit Plan..........................................................................................................................41
8.1
Overview............................................................................................................................41

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8.2
Baseline II Visit /Visit 1 (Visit 7 of the lead-in study)......................................................42
8.3
Baseline III Visit /Visit 6 [open-label treatment period with memantine (substudy)].......42
8.4
Withdrawal Visit................................................................................................................43
8.5
Safety Follow-up Visit (Visit 7 and Visit 12)....................................................................43
8.6
Unscheduled Visit (Dispensing Unscheduled Study Visit) ...............................................44
8.7
End-of-study Definition.....................................................................................................44
9
Assessments ................................................................................................................................45
9.1
Baseline Procedures and Assessments...............................................................................45
9.1.1
Use of Efficacy Assessments .............................................................................45
9.1.1.1
Mini Mental State Examination (MMSE)........................................45
9.1.1.2
Alzheimer’s Disease Assessment Scale – cognitive sub-scale 
(ADAS-Cog)....................................................................................46
9.1.1.3
Alzheimer’s Disease Cooperative Study – Clinical Global 
Impression of Change (ADCS-CGIC).............................................46
9.1.1.4
Alzheimer’s Disease Co-operative Society – Activities of Daily 
Living (ADCS- ADL) Inventory .....................................................47
9.1.1.5
Neuropsychiatric Inventory (NPI) ...................................................47
9.1.2
Rater Qualification.............................................................................................47
9.1.3
For new raters joining the study.........................................................................47
9.2
Pharmacoeconomic Assessments ......................................................................................48
9.2.1
EQ-5D-3L (proxy)..............................................................................................48
9.2.2
Resource Utilisation in Dementia (RUD) – Lite................................................49
9.2.3
Dependence scale...............................................................................................49
9.3
Pharmacokinetic Assessments...........................................................................................49
9.4
Safety Assessments............................................................................................................50
9.4.1
Adverse Events...................................................................................................50
9.4.2
Clinical Safety Laboratory Tests........................................................................50
9.4.3
Vital Signs..........................................................................................................52
9.4.4
Weight................................................................................................................53
9.4.5
Electrocardiograms (ECGs) ...............................................................................53
9.4.6
Physical and Neurological Examinations...........................................................54
9.4.7
Columbia Suicide Severity Rating Scale (C-SSRS)...........................................54
9.5
Total Volume of Blood Drawn and Destruction of Blood.................................................55
9.6
Patient Compliance............................................................................................................56
10
Adverse Events...........................................................................................................................56
10.1
Definitions .........................................................................................................................56
10.1.1
Adverse Event Definitions .................................................................................56
10.1.2
Adverse Event Assessment Definitions .............................................................57
10.2
Pregnancy ..........................................................................................................................58
10.3
Recording Adverse Events ................................................................................................58
10.4
Reporting Serious Adverse Events ....................................................................................59
10.5
Treatment and Follow-up of Adverse Events....................................................................60
10.6
Study Monitoring Committees ..........................................................................................60
10.6.1
Data Monitoring Committee ..............................................................................60
11
Data Handling and Record Keeping ........................................................................................61
11.1
Data Collection..................................................................................................................61
11.1.1
Electronic Case Report Forms (eCRFs).............................................................61
11.1.2
Patient Binders ...................................................................................................61
11.1.2.1
Use of Patient Binders .....................................................................61

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11.1.2.2
Rating Scales and Caregiver Outcome ............................................61
11.1.2.3
Serious Adverse Event Fallback Forms...........................................62
11.1.3
External Data......................................................................................................62
11.2
Retention of Study Documents at the Site.........................................................................62
11.2.1
eCRF Data..........................................................................................................62
11.2.2
Other Study Documents .....................................................................................62
12
Monitoring Procedures..............................................................................................................63
13
Audits and Inspections ..............................................................................................................63
14
Protocol Compliance..................................................................................................................63
15
Study Termination.....................................................................................................................64
16
Statistical Methodology .............................................................................................................64
16.1
Responsibilities..................................................................................................................64
16.2
Analysis Sets......................................................................................................................64
16.3
Descriptive Statistics .........................................................................................................65
16.4
Patient Disposition.............................................................................................................65
16.5
Demographics and Other Baseline Characteristics............................................................65
16.6
Recent and Concomitant Medication.................................................................................65
16.7
Exposure ............................................................................................................................66
16.8
Efficacy Analyses..............................................................................................................66
16.9
Safety Analyses .................................................................................................................66
16.9.1
Analysis of Adverse Events ...............................................................................66
16.9.2
Analysis of Other Safety Endpoints...................................................................67
16.9.3
Analysis of Liver Tests ......................................................................................67
16.10 Interim Analyses................................................................................................................67
16.11 Sample Size and Power .....................................................................................................67
16.12 Statistical Analysis Plan ....................................................................................................68
17
Clinical Study Report and Publications...................................................................................68
17.1
Clinical Study Report ........................................................................................................68
17.2
Data Ownership .................................................................................................................68
17.3
Publications........................................................................................................................68
18
Indemnity and Insurance ..........................................................................................................68
19
Finance........................................................................................................................................69
19.1
Site Agreement ..................................................................................................................69
19.2
Financial Disclosure ..........................................................................................................69
19.3
Equipment..........................................................................................................................69
References.............................................................................................................................................70

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Appendices
Appendix I
Clinical Study Protocol Authentication and Authorisation..........................72
Appendix II
     Recent and Concomitant Medication: 
     Disallowed or Allowed with Restrictions........................................................74
Appendix III
Non-site Study Personnel and Vendors..........................................................78
Appendix IV
Lead-in Study Treatment Designs ..................................................................81

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List of Panels
Panel 1
Study Design........................................................................................................................8
Panel 2
Study Procedures and Assessments [open-label treatment period (initial  28-week 
period)] ................................................................................................................................9
Panel 3
Study Procedures and Assessments [open-label treatment with memantine 
(substudy)].........................................................................................................................11
Panel 4
Dose Schedules..................................................................................................................38
Panel 5
Clinical Safety Laboratory Tests .......................................................................................51

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List of Abbreviations and Definitions of Terms
GT
-glutamyl transferase
5-HT
serotonin
ACh
acetylcholine
AChE
acetylcholinesterase
AD
Alzheimer’s disease
ADAS-Cog
Alzheimer’s Disease Assessment Scale, cognitive subscale
ADCS-ADL23
Alzheimer’s Disease Cooperative Study – Activities of Daily Living Inventory
ADCS-CGIC
Alzheimer’s Disease Cooperative Study – Clinical Global Impression of Change
ADL
Activities of Daily Living
AE
adverse event
ALT
alanine aminotransferase
AP
alkaline phosphatase
APTS
all-patients-treated set
AST
aspartate aminotransferase
ATC
anatomical therapeutic chemical
AUC
area under the curve
BMI
body mass index
BP
blood pressure 
BUN
blood urea nitrogen
CIAS
cognitive impairment associated with schizophrenia (CIAS)
Cmax
maximum observed concentration
CRA
clinical research associate
CRF
case report form
CRP
C-reactive protein
C-SSRS
Columbia-Suicide Severity Rating Scale
CYP
cytochrome P450 isoenzyme
DMC
Data Monitoring Committee
ECG
electrocardiogram
eCRF
electronic case report form
EudraCT
European Union Drug Regulating Authorities Clinical Trials
FDA
United States Food and Drug Administration
GABA
gamma-aminobutyric acid
GPV
Division of Global Pharmacovigilance, H. Lundbeck A/S
HBsAg
hepatitis B surface antigen
HCV
hepatitis C virus
HIV
human immunodeficiency virus
IB
Investigator’s Brochure

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ICH
International Conference on Harmonisation of Technical Requirements for 
Registration of Pharmaceuticals for Human Use
ICMJE
International Committee of Medical Journal Editors
IEC
independent ethics committee
IMP
investigational medicinal product
IND
investigational new drug application
INR
international normalised ratio of prothrombin time
IRB
institutional review board
IVRS
interactive voice response system
Lu
Lundbeck
MMRM
mixed model for repeated measurements
MMSE
Mini Mental State Examination
NA
not applicable
NPI
Neuropsychiatric Inventory
PBO
placebo
PCS
potentially clinically significant
PR
specific ECG interval describing atrioventricular conduction 
QP
qualified person
QRS
specific ECG interval describing ventricular depolarisation
QTcF
heart-rate corrected QT interval using Fridericia’s correction formula
REML
restricted maximum likelihood
RUD Lite
Resource Utilisation in Dementia Lite 
SAE
serious adverse event
SmPC
Summary of Product Characteristics
SOC
system organ class
SUSAR
suspected unexpected serious adverse reaction
TBL
total bilirubin level
TEAE
treatment-emergent adverse event
TID
three times daily
TMF
trial master file
ULN
upper limit of normal

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1
Introduction
1.1
Background
1.1.1
Overview
Alzheimer’s disease (AD) is an irreversible, chronic and progressive neurodegenerative 
disease which gradually destroys memory, and the ability to learn, reason, make judgements, 
communicate, and carry out daily activities. In addition, patients may develop symptoms such 
as inappropriate behaviour and neuropsychological symptoms including aggression, agitation, 
apathy, depression, and hallucinations. Sleep disturbances are also commonly seen in AD 
patients.
AD is estimated to affect between 4 to 8% of the population aged above 65 years, and more 
than 20% of those aged above 85 years. Three disease stages are commonly described in AD: 
mild, moderate and severe. Today, on average, only half of the patients with AD are correctly 
diagnosed, most of them in the moderate to severe stages of the disease, and a high percentage 
of them are not treated with adequate medication. 
Idalopirdine is a selective serotonin receptor 6 (5-HT6 receptor) antagonist, which is being 
jointly developed by H. Lundbeck A/S and Otsuka Pharmaceutical Co, Ltd.. Idalopirdine has 
been shown to improve cognitive performance when administered as adjunctive treatment to 
the acetylcholinesterase (AChE) inhibitor donepezil in a randomised, double blind, parallel-
group, placebo-controlled, fixed-dose study (12936A) conducted in patients with moderate 
AD. The 5-HT6 antagonists have pro-cognitive effects in rodents, possibly mediated through 
a blockade of excitatory input to gamma-aminobutyric acid (GABA)-ergic neurons in the 
hippocampus and cortex, leading to an indirect enhancement of cholinergic, dopaminergic, 
and glutamatergic neurotransmission. 
The following sections provide an overview of the non-clinical and clinical data currently 
available for idalopirdine. Refer to the current version of the Investigator’s Brochure (IB)1 for 
more detailed information.
1.1.2
Non-clinical Data
Idalopirdine is a high affinity antagonist for the 5-HT6 receptor. Broad profiling of 
idalopirdine in more than 100 additional assays demonstrated medium affinity to the 
adrenergic α-1A and α-1B receptors and to the dopamine D3 receptor. Efficacy profiling 
showed that idalopirdine was an antagonist for the adrenergic α-1A, α-1B and dopamine D3 
receptors. For all the remaining targets tested, idalopirdine demonstrated at least 100-fold 
selectivity. 
Idalopirdine has been shown to improve performance in multiple rodent cognition tasks. In 
doses leading to >65% striatal 5-HT6 receptor occupancy in vivo, idalopirdine reversed 

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cognitive impairment induced by subchronic phencyclidine in rats. There is no preclinical 
evidence to demonstrate the cognitive benefits of concomitant treatment of idalopirdine, 
donepezil and memantine. In microdialysis studies, administration of idalopirdine alone did 
not affect extracellular levels of GABA, dopamine, 5-HT or acetylcholine (ACh) in the rat 
prefrontal cortex, whereas idalopirdine (5 mg/kg per os) significantly potentiated donepezil-
induced increases in extracellular levels of ACh. This suggests the possibility of synergistic 
effects when combining idalopirdine with acetylcholine esterase inhibitors. 
Safety pharmacology and toxicology studies indicate that at clinically relevant exposure 
levels, idalopirdine is well tolerated. Multiple-dose toxicology studies were conducted in rats 
and monkeys at doses up to 250 mg/kg and 50 mg/kg, respectively. In monkeys, convulsions 
occurred at high exposure levels. In rats, increased blood clotting time was noticed at high 
exposure levels. 
Exploratory data using human recombinant enzymes indicated that cytochrome P450 
isoenzyme (CYP) 3A4 was the major CYP450 enzyme involved in the metabolism of 
idalopirdine with some contribution from CYP1A2, CYP2C9, CYP2C19, and CYP2D6. 
Idalopirdine showed inhibitory potential towards CYP2D6. Furthermore, in an in vitro study 
evaluating the induction potential of idalopirdine, idalopirdine showed little (CYP2B6 and 
CYP2C8) or no induction potential (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, 
CYP2D6 and CYP3A4/5) towards the CYPs investigated.
Further information can be found in the IB.1
1.1.3
Clinical Data
Six clinical pharmacology studies and three clinical studies with idalopirdine have been 
performed, the three clinical studies were: 
• Study 12936A, (phase II, randomised, double-blind, parallel-group, placebo-controlled, 
fixed-dose study exploring the efficacy and safety of idalopirdine as adjunctive therapy to 
donepezil in patients with moderate AD). 
• Study CL03 (11974A), (phase II, double-blind, placebo-controlled, dose-ranging parallel-
group study in patients with cognitive impairment associated with schizophrenia (CIAS)).
• Study 12450A, (phase II, randomised, double blind, parallel-group, fixed-dose study 
exploring the efficacy and safety of idalopirdine as augmentation therapy to risperidone in 
patients with schizophrenia).
The lead-in studies for this protocol (studies 14861A and 14862A) are phase III, randomised, 
double-blind, parallel-group, placebo-controlled studies designed to evaluate efficacy and 
safety of idalopirdine over a 24-week period in a total of 1770 patients with mild-moderate 
AD treated with donepezil.

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1.1.3.1
Pharmacokinetics and Pharmacodynamics
In the previous phase II AD study (12936A), the estimated mean idalopirdine maximum 
concentration (Cmax) and the area under the curve (AUC0-24h) following a 30 mg three times 
daily (TID) dosing regimen were 540 ng/mL and 11700 h*ng/mL, respectively. Based on the 
same population PK model, the estimated exposures following the 30 mg once daily and 60
mg once daily dosing regimens will be mean Cmax 180 ng/mL and 390 ng/mL, and mean 
AUC0-24h 3170 h*ng/mL and 6930 h*ng/mL, respectively.
Donepezil is mainly metabolised by CYP3A4 and to a minor extent by CYP2D6. In study 
12936A, the estimated impact of idalopirdine CYP2D6 inhibition on donepezil clearance was 
in agreement with the observed donepezil exposure at Week 4 and onwards (10% reduction in 
clearance). In the current study, the impact on donepezil clearance and exposure is expected 
to be of the same order of magnitude or slightly lower, due to the decreased dose.
The doses in the current phase III clinical program and present study have been selected based 
on the data from a clinical 5-HT6 receptor occupancy study (in reporting) and simulations in 
AD patients. 30mg/day and 60 mg/day idalopirdine are predicted to be the clinically effective 
doses based on the high 5-HT6 receptor occupancy. 
1.1.3.2
Efficacy
Idalopirdine 90 mg/day (30 mg TID) was shown to be effective in improving cognitive 
function in donepezil-treated patients with moderate AD in the study 12936A. This was 
supported by trends toward improvement in functional and global clinical measures. 
1.1.3.3
Safety
Idalopirdine was safe and generally well tolerated in healthy subjects (young and elderly men 
and women) following multiple doses up to 300 mg/day with no clinical significant effects on 
vital signs, clinical laboratory tests or ECG parameters.
In the phase II study, 12936A, conducted in patients with AD, idalopirdine was safe and, with 
the exception of elevated transaminase values, well tolerated as adjunctive therapy to 
donepezil in patients with AD at a dose of 90 mg/day (30 mg TID) for 6 months.
In this study, the incidence of treatment-emergent adverse events (TEAEs) was slightly higher 
in the idalopirdine group (66%) than in the placebo group (59%). The most common adverse 
events, (occurring in >2 patients and with an incidence of more than 4% and with a >2 times 
higher incidence in patients treated with idalopirdine than in patients treated with placebo), 
were γ-glutamyltransferase increased, Alanine aminotransferase (ALT) increased, Aspartate 
aminotransferase (AST) increased, Dizziness, Headache, Aggression, and Vomiting. 
The proportion of patients who withdrew due to TEAEs in this study was 15% in the 
idalopirdine group and 7.5% in the placebo group. The differential withdrawal was almost 
entirely due to elevated liver enzymes test values reported as TEAEs. 

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A total of 14 (9.7%) patients in the idalopirdine group and 13 (9.8%) patients in the placebo 
group had one or more serious adverse events (SAEs). 
There were more patients in the idalopirdine group than in the placebo group who had AST, 
ALT and/or alkaline phosphatase (AP) values above the upper limit of normal (ULN) at some 
point during the study. There were no differences between the treatment groups in the 
incidence of total bilirubin level (TBL) above ULN. A total of 13 patients (all in the 
idalopirdine group) had AST or ALT values that were >2 times ULN. The elevated liver test 
values were seen around week 8. For all the 13 patients, the liver test values subsequently 
decreased towards the reference range. The mechanism behind these increased liver tests is 
currently unknown. 
Except for liver tests, the changes from baseline for all clinical safety laboratory tests and 
ECGs showed, on average, small fluctuations without clinical relevance and with no trends 
over time or between the treatment groups.
In the two phase II studies conducted in patients with schizophrenia, idalopirdine was safe
and well tolerated for up to 12 weeks. 
Further information on the safety of idalopirdine can be found in the IB.1
1.2
Rationale for the Study
The lead-in studies aim at establishing the efficacy and safety of idalopirdine as adjunctive 
therapy to donepezil in patients with mild-moderate AD. The open label extension study will 
provide supportive long term data on the safety, tolerability and efficacy of idalopirdine. The 
dose of 60 mg/day is chosen both because of the aim to expose patients to the highest 
therapeutic dose, which is considered the most relevant for generating safety data, and 
because of the simplicity of having only one open-label treatment arm. However, a permanent 
dose decrease to 30 mg/day is allowed, if the dose of 60 mg/day is not well tolerated. 
AD is a progressive neurodegenerative disease that is characterised by a steady decline in a 
patient’s cognition and function and an increase in behavioural problems. Thus in a complex 
disease like AD, there is a strong medical need for alternative treatment options which include 
combining the different symptomatic treatments with diverse pharmacological modes of 
action. The open-label treatment period with memantine (substudy) will evaluate the safety 
and tolerability of adding memantine therapy in patients who are already on a stable treatment 
of idalopirdine and donepezil and for whom memantine treatment is clinically indicated. 
Concomitant treatment with the three compounds has not been studied in previous or on-
going clinical trials. Furthermore, adjunctive treatment with memantine is likely to be a 
common treatment option for patients with AD soon after idalopirdine becomes available. 
Thus the open-label treatment period with memantine (substudy), in the current study, is 
designed to inform potential future clinicians and patients of the safety and tolerability profile 
to expect when the three compounds are used concomitantly.

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2
Objectives
2.1
Primary Objective
Open-label treatment period (initial 28-week period):
To evaluate the long term safety and tolerability of idalopirdine as adjunctive therapy to 
donepezil in patients with mild-moderate AD.
Open-label treatment period with memantine (substudy):
To evaluate the safety and tolerability of concomitant treatment with idalopirdine, memantine 
and donepezil in patients with AD.
2.2
Secondary Objective
Open-label treatment period (initial 28-week period):
To evaluate the long term disease development during treatment with idalopirdine as 
adjunctive therapy to donepezil.
Open-label treatment period with memantine (substudy):
To evaluate the disease development during concomitant treatment with idalopirdine, 
memantine and donepezil in patients with AD.
2.3
Other Objectives
Open-label treatment period with memantine (substudy):
To explore population pharmacokinetics.
3
Study Design
3.1
Overview of the Study Design
This study has been designed in accordance with the Declaration of Helsinki.2
This is an interventional, multi-national, multi-site, open-label extension study in patients 
with mild to moderate AD, who completed Visit 7 (Completion Visit) in the lead-in study. 
The Baseline II Visit is the same visit as Visit 7 (Completion Visit) in the lead-in study. 
Investigator will be informed about which treatment their patients received only after the last 
patient from their respective lead-in study has completed the extension study.

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This study will be conducted in compliance with the protocol, Good Clinical Practice,3 and 
applicable regulatory requirements.
Approximately 240 sites (hospitals or specialist centres) are planned in 30-35 countries. Up to 
1770 patients with mild-moderate AD, who have completed Visit 7 (Completion Visit) in the 
lead-in study may be eligible for the 14861B study. For the open-label treatment period with 
memantine (substudy) approximately 100 patients, who have completed the open-label 
treatment period (initial 28-week period, i.e., Visit 6); will be enrolled if they consent to 
continue and if they fulfil all inclusion and none of the exclusion criteria at the Baseline III 
Visit. Thus approximately 70-90 sites in 13 countries are planned to participate (hospitals or 
specialist centres) in the open-label treatment period with memantine (substudy). Only certain 
sites within a country will be selected to participate and will depend primarily on the site’s 
potential eligible patient population.
For sites not participating in the open-label treatment period with memantine (substudy), the 
study will include one period. For sites participating in the open-label treatment period with 
memantine (substudy), the study will include two consecutive periods:
• Open-label treatment period (initial 28-week period): 28-weeks with idalopirdine 60 
mg/day as adjunctive treatment to donepezil (10 mg/day). The dose of idalopirdine can be 
decreased to 30 mg/day if 60 mg/day is not well tolerated in the opinion of the investigator 
during this 28-week period only. The Baseline Visit of this period (Baseline II) will be the 
same visit as Visit 7 (Completion Visit) in the lead-in studies.
• Open-label treatment period with memantine (substudy): 24-weeks with idalopirdine 60 
mg/day (or 30 mg/day) [continuation of dose used in open-label treatment period (initial 
28-week period)] as adjunctive treatment to donepezil hydrochloride 10 mg/day and me-
mantine (patient’s individualised maintenance dose; including a titration phase of up to 3 
weeks). Memantine should be prescribed according to investigator's judgement and the 
initial dose may be changed at any time throughout the course of the study if clinically 
indicated in the opinion of the investigator. The dose and dosing regimen of donepezil and 
idalopirdine in the 24-week period must remain fixed at that given in the open-label treat-
ment period (initial 28-week period). The Baseline Visit of this period (Baseline III) will 
be the same visit as Visit 6 in the open-label treatment period (initial 28-week period).
Patients completing the open-label treatment period (initial 28-week treatment period) and 
who will not continue into the 24-week open-label treatment period with memantine
(substudy) will enter a 4-week safety follow-up period. Thus the total study duration per 
patient from Baseline II to the end of the follow-up will be approximately 32 weeks.
Patients completing the two consecutive treatment periods will enter a 4-week safety follow-
up period. Thus the total study duration per patient from Baseline II to the end of the follow-
up will be approximately 56 weeks. 
A Safety Follow-up Visit will be performed 4 weeks (+ up to 7 days) after the 
Completion/Withdrawal Visit, whether completion or withdrawal.

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Patients who discontinue will complete a withdrawal visit at the time of withdrawal, or as 
soon as possible thereafter. Withdrawn patients, except for those who withdraw consent, will 
be scheduled for a Safety Follow-up Visit 4 weeks (+ up to 7 days) after the Withdrawal Visit 
in order to follow-up on safety after withdrawal from IMP therapy. Patients who withdraw 
their consent should still have a Safety Follow-up Visit, but the visit must only be recorded in 
the medical records. 
An overview of the study is presented in Panel 1 and the scheduled assessments are 
summarised in Panel 2 [open-label treatment period (initial 28-week period)] and Panel 3
[open-label treatment period with memantine (substudy)].
A Data Monitoring Committee (DMC) has been established for this study. The DMC will 
provide risk benefit assessments of the study to the sponsor at predefined intervals as further 
described in the DMC Charter (see section 10.6.1).
3.2
Rationale for the Study Design
This study is designed as a classic open-label extension study with add-on design to evaluate
the long term safety and tolerability of idalopirdine as adjunctive therapy to donepezil in 
patients with mild-moderate AD.
The study population will comprise AD patients who have completed Visit 7 (Completion 
Visit) in the lead-in study. 
All patients will receive a dose of (60 mg/day) of idalopirdine, with a possibility to 
permanently decrease the dose to 30 mg/day if 60 mg/day is not well tolerated in the opinion 
of the investigator.
The doses of idalopirdine allowed in the study are considered to be safe and well tolerated 
based on prior clinical data.
It is expected that majority of the patients will be exposed to 60 mg/day for the first time;
therefore the safety assessments in this study will be identical to the safety assessments in the 
lead-in studies.
The open-label treatment period with memantine (substudy) will be offered to patients who 
have already been exposed to idalopirdine for 6-12 months and for whom memantine 
treatment is clinically indicated, and will allow them to continue with their idalopirdine 
treatment (60 mg/day or 30 mg/day) for a further 6 month period.
Thus the design offers a highly relevant platform, as patients will have received at least 6 
months of idalopirdine treatment prior to the addition of memantine and provides the ability 
to compare safety and tolerability, within the same patient, before and after the addition of 
memantine.

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4
Ethics
4.1
Ethical Rationale
Patients will be fully informed about the study including the risks and benefits of his/her 
participation in the study.
The patient may withdraw from the study at any time, for any reason, specified or unspecified 
and without penalty or loss of benefits to which the patient is otherwise entitled. Unscheduled 
visits can be made and immediate withdrawal is possible. Throughout the study, signs of 
suicidal risk will be assessed and patients at risk will be withdrawn from the study. 
All patients participating in this study will receive idalopirdine and donepezil. Furthermore,
during the open-label treatment period (initial 28-week period), the dose of idalopirdine can 
be decreased to 30 mg/day if 60 mg/day is not well tolerated in the opinion of the investigator.
The risks associated with this study are considered adequately elucidated in the non-clinical 
and clinical studies, well controlled by cautionary measures in the study design, and well 
balanced with the potential benefits of the treatment.
Since the study will enrol patients with dementia, special attention must be paid to the 
procedures for informed consent. Ample time must be given for explanation of the 
consequences of participation in the study. Detailed local procedures on the informed consent 
process for the patient (or, if applicable, the legal representative) and caregiver must fulfil 
GCP standards, be in accordance with the Declaration of Helsinki,2 and comply with national 
laws/Ethics Committees requirements.
In accordance with Good Clinical Practice,3 qualified medical personnel at the sponsor or at 
the Clinical Research Organisation (CRO) will be readily available to advice on study-related 
medical questions. Medical monitoring will be performed throughout the study. Safety data 
will be reviewed regularly by the Lundbeck Idalopirdine Safety Committee to ensure that 
prompt action is taken, if needed, to maximise patient safety.
A Data Monitoring Committee (DMC) has been established for the study. The DMC ensures 
that the ethical principles are observed and monitors the safety of the patients
(see section 10.6.1).
Open-label treatment period with memantine (substudy):
All patients participating in the open-label treatment period with memantine (substudy) will 
receive idalopirdine, memantine and donepezil. The study period will allow inclusion of 
patients for whom the investigator believes that memantine treatment is warranted. As 
patients advance into the moderate stage of AD there may be a need for additional therapy, 
such as the addition of memantine, to alleviate symptoms that can no longer be managed on 
the patient’s current therapy alone. By participating in the study period the patient would 
provide important safety and tolerability information when idalopirdine, memantine and 

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donepezil are used concomitantly. Memantine will be prescribed according to the local 
label/SmPC/guidelines meaning that the dose of memantine can be adjusted, if clinically 
indicated in the opinion of the investigator. In addition, the patients will continue receiving 
idalopirdine and their donepezil base treatment for a further 6-month period. Consequently, 
no patient will be denied access to treatment. In summary, it is considered ethical to evaluate 
the safety and tolerability of adding memantine treatment in patients participating in study 
14861B, i.e., in patients who are already on a stable treatment of idalopirdine and donepezil 
and for whom memantine treatment is clinically indicated. It is important to consider that all 
patients in study 14861B would be discharged after trial participation and be able to continue 
on whichever therapy, including memantine, if clinically indicated by the investigator.
4.2
Informed Consent
No study-related procedures may be performed before the investigator has obtained written 
informed consent from the patient and/or his or her legal representative and the caregiver.
It is the personal responsibility of the investigator to obtain written informed consent from the 
patient and/or his or her legal representative and the caregiver.
If parts of the informed consent process (such as giving information) may be delegated, the 
requirements for the delegates must be documented prior to the start of the study. National 
laws must always be adhered to when allowing potential delegation. Any delegation must be 
documented in the site delegation log.
The investigator must identify vulnerable patients, that is, patients whose willingness to 
participate in this study might be unduly influenced by the expectation, regardless of whether 
it is justified, of benefits associated with participation, or of a retaliatory response from senior 
members of a hierarchy in case of refusal to participate. Patients thus identified must be 
excluded from participation in the study.
Prior to obtaining written informed consent, the investigator or a designee must explain to the 
patients and/or their legal representatives and the caregivers, the aims, methods, and potential 
hazards of the study and any discomfort it may entail. The patients and/or their legal 
representatives and the caregivers must be informed that their participation in the study is 
voluntary and that they are free to withdraw from the study at any time without justifying 
their decision. The patients and/or their legal representatives and the caregivers must be 
informed of the possibility of withdrawing consent (section 8.3).
The patients and/or their legal representatives and the caregivers must be given ample time
and opportunity to inquire about details of the study prior to deciding whether to participate in 
the study.
It is the responsibility of the investigator to ensure that all questions about the study are 
answered to the satisfaction of the patients and/or their legal representatives and the 
caregivers. Prior to including a patient in the study, an Informed Consent Form must be 
signed and dated by the patient and/or his or her legal representative and the caregiver and 

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signed and dated by the investigator on the same day. The patients and/or their legal 
representatives and the caregivers must receive a copy of the written information (Patient 
Information Sheet) as well as a copy of the signed Informed Consent Form. 
Open-label treatment period with memantine (substudy):
The open-label treatment period with memantine (substudy) is optional and will only be 
required for patients who meet the eligibility criteria for this part of the study and consent to 
continue. 
The principles of consent outlined above also apply to the open-label treatment period with 
memantine (substudy). The investigator must obtain a separate written Informed consent from 
the patient and/or his or her legal representative and their caregivers before any procedures 
related to the open-label treatment period with memantine (substudy) are performed.
It is suggested that the Informed Consent Form is provided at Visit 5 of the open-label 
treatment period (initial 28-week period) for patients who may potentially be eligible and who 
wish to participate in the open-label treatment period with memantine (substudy).
The patients and/or their legal representatives and the caregivers must receive a copy of the 
written information (Patient Information Sheet) as well as a copy of the signed Informed 
Consent Form for this open-label treatment period with memantine (substudy).
4.3
Patient Contact Arrangements
The site personnel will document the patient’s living arrangements and working arrangements 
in the patient’s medical records at Visit 1. At each subsequent visit, the site personnel will ask 
appropriate follow-up questions regarding the arrangements and who the patient has been in 
contact with on a regular basis; the contact’s name does not need to be recorded. Details 
documenting the contact will be recorded in the patient’s medical records. This procedure will 
be documented in the Site Initiation Visit Report and signed by the investigator.
4.4
Personal Data Protection
In accordance with European Union Directive 95/46/EC,4 the data will be processed in 
accordance with the specifications outlined by the Danish Data Protection Agency to ensure 
that requirements regarding personal data protection are met. If an external organisation will 
process data on behalf of Lundbeck, a contractual procedure will be signed between 
Lundbeck and the external organisation to ensure compliance with the above-mentioned 
legislation.
If applicable, the participation of patients in this study will be reported to the appropriate local 
data protection agencies, in accordance with European Union Directive 95/46/EC and 
country-specific guidelines and laws.

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4.5
Independent Ethics Committees (IECs) and Institutional Review Boards (IRBs)
This study will be conducted only after approval of the protocol has been granted by the 
appropriate IEC or IRB and a copy of the written approval has been received by Lundbeck.
The investigator must not include any patients before receiving written approval from the IEC 
or IRB.
The IEC or IRB must be informed when specific types of protocol amendments have been 
made and must be asked whether a re-evaluation of the ethical aspects of the study is 
necessary.
If applicable, interim reports on the study and reviews of its progress will be submitted to the 
IEC or IRB by the investigator at intervals stipulated in its guidelines.
4.6
Regulatory Approval/Notification Requirements
In accordance with local requirements, this study will be submitted to the regulatory 
authorities for approval or notification. The study will only be undertaken when Lundbeck has 
received written approval or confirmation of notification from the regulatory authorities.
5
Study Population
5.1
Numbers of Patients and Sites
This study will include eligible patients who have completed Visit 7 (Completion Visit) in the 
lead-in study (maximum 1770 patients). Approximately 240 sites (hospitals and specialist 
centres) are planned in 30-35 countries.
Approximately 100 patients with Alzheimer’s disease, who have completed the open-label 
treatment period (initial 28-week period), will be enrolled into the open-label treatment period 
with memantine (substudy). Approximately 70-90 sites in 13 countries (Bulgaria, Canada, 
Czech Republic, Estonia, Germany, France, Italy, Lithuania, Poland, South Korea, Spain, 
United Kingdom and United States) are planned to participate (hospital and specialist 
centres). Only certain sites within a country will be selected to participate and will depend 
primarily on the site’s potential eligible patient population.
5.2
Patient Recruitment
Open-label treatment period with memantine (substudy):
As 100 patients are expected to be enrolled in the open-label treatment period with memantine
(substudy), the recruitment for this treatment period will end prior to the global recruitment 
period for the open-label treatment period of study 14861B. 

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The investigators will be notified immediately, when the recruitment period comes to an end.
Distribution of enrolled patients will be monitored closely to ensure there is a balanced 
representation of patients across regions.
5.3
Selection Criteria
Patient selection is based on the inclusion and exclusion criteria listed below.
Patients who meet each of the inclusion criteria at the Baseline II Visit and none of the 
exclusion criteria at the Baseline II Visit are eligible to participate in this study. 
Open-label treatment period (initial 28-week period):
Inclusion Criteria
1.
The patient has completed Visit 7 (Completion Visit) in the lead-in study. 
2.
The patient’s sight and hearing (hearing aid permissible) are, in the investigator’s 
judgement, sufficient for compliance with the study procedures.
3.
The patient (and/or if applicable the legal representative if different from the responsible 
caregiver) and the responsible caregiver are able to read and understand the Informed 
Consent Form.
4.
The patient (and/or if applicable the legal representative if different from the responsible 
caregiver) and the responsible caregiver have signed the Informed Consent Form.  
5.
The patient is willing and able to attend study appointments within the specified time 
windows.
6.
The patient has a knowledgeable and reliable caregiver who will accompany the patient 
to all clinic visits during the study.
7.
The patient, if a man, must:
- use two methods of contraception in combination if his female partner is of 
childbearing potential; this combination of contraceptive methods must be used from 
the Baseline II Visit to ≥1 month after the last dose of IMP, OR 
- have been surgically sterilised prior to the Completion Visit in the lead-in study.
Exclusion Criteria
1.
The patient has experienced seizures before Completion Visit in the lead-in study.
2.
The patient has evidence of clinically significant disease including but not limited to 
pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease or 
metabolic disturbance (patients with controlled diabetes, or patients with controlled 
hypertension, or right bundle branch block, complete or partial, may be included in the 
study). Patients with pacemakers are eligible provided that they follow a routine check-up 
with their doctor and are considered stable. As specified in the donepezil summary of 
product characteristics (SmPC) special precaution is needed for patients with asthma, 
obstructive pulmonary disease, bradycardia, or difficulty in passing urine.

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3.
The patient takes or has taken disallowed recent or concomitant medication (specified in
Appendix II) or it is anticipated that the patient will require treatment with at least one of 
the disallowed concomitant medications during the study. 
4.
The patient’s donepezil treatment is likely to be interrupted or discontinued during the 
study.
5.
The patient is receiving therapy with another AChEI or memantine.
6.
The patient has clinically significant abnormal vital signs at the Completion Visit in the 
lead-in study considered a potential safety risk by the Investigator.
7.
The patient has a moderate or severe on-going adverse event from the lead-in study 
considered a potential safety risk by the investigator.
8.
The patient has been tested positive for hepatitis B surface antigen (HBsAg), or hepatitis 
C virus/antibodies (anti-HCV), AND had abnormal ALT, AST or bilirubin in the lead-in 
study.
9.
The patient has been tested positive for hepatitis B surface antigen (HBsAg), or hepatitis 
C virus/antibodies (anti-HCV) for the first time within the last 6 months prior to the 
Completion Visit in the lead-in study.
10. The patient has one or more clinical laboratory test values outside the reference range, 
based on the latest blood and urine sample results, available at the Completion Visit in
the lead-in study, that are of potential risk to the patient’s safety, or the patient has
according to the latest available blood sample:
- a serum creatinine value >1.5 times the upper limit of the reference range, or
- a serum total bilirubin value >1.5 times the upper limit of the reference range, or 
- a serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value 
>1.5 times the upper limit of the reference range.
11. The patient has, based on the latest ECG results, available at the Completion Visit in the 
lead-in study:
- an abnormal ECG that is, in the investigator’s opinion, clinically significant, or 
- a heart rate <45 beats per minute, or
- a PR interval >280 ms, or
- a QRS interval >150 ms, or
- a QTcF interval >480 ms (based on the Fridericia correction where QTcF = 
QT/RR0.33)
Patients with a heart rate between 45 and 49 beats per minute or a PR interval between 
250 and 280 ms, based on the latest ECG results, available at the Completion Visit in the 
lead-in study, must be discussed with the sponsor medical expert before being enrolled. 
The patients can be considered eligible, provided they are stable and there is no safety 
risk related to their participation in the study as per the investigator's judgement.
12. The patient is, in the investigator’s opinion, unlikely to comply with the protocol or is
unsuitable for any reason.
13. The patient has attempted suicide within the last 6 months or is at significant risk of 
suicide (either in the opinion of the Investigator or defined as a “yes” to suicidal ideation 
questions 4 or 5 or answering “yes” to suicidal behaviour on the C-SSRS within the last 
12 months).

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Open-label treatment period with memantine (substudy):
Patients who meet each of the inclusion criteria at the Baseline III Visit and none of the 
exclusion criteria at the Baseline III Visit are eligible to participate in the open-label treatment 
period with memantine (substudy).
Inclusion Criteria
1.
The patient has completed Visit 6 [(i.e., the open-label treatment period (initial 28-week 
period)].
2.
The patient’s sight and hearing (hearing aid permissible) are, in the investigator’s 
judgement, sufficient for compliance with the study procedures.
3.
The patient (and/or if applicable the legal representative if different from the responsible 
caregiver) and the responsible caregiver are able to read and understand the Informed 
Consent Form.
4.
The patient (and/or if applicable the legal representative if different from the responsible 
caregiver) and the responsible caregiver have signed the Informed Consent Form.
5.
The patient is willing and able to attend study appointments within the specified time 
windows.
6.
The patient has a MMSE score at the Baseline III Visit of this study not greater than 19 in 
accordance with the memantine label/summary of product characteristics (SmPC).
7.
The patient, according to the judgement of the investigator, requires initiation of 
treatment with memantine as per local label/SmPC/treatment guidelines.
8.
The patient has a knowledgeable and reliable caregiver who will accompany the patient 
to all clinic visits during the study.
9.
The patient, if a man, must:

use two methods of contraception in combination if his female partner is of childbear-
ing potential; this combination of contraceptive methods must be used from the Base-
line III Visit of this study to ≥ 1 month after the last dose of IMP, OR 

have been surgically sterilised prior to Visit 6.

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Exclusion Criteria
1.
The patient exhibits an increase in the MMSE score by 3 points or more at Visit 6 from 
Baseline II Visit.
2.
The patient has experienced seizures before Visit 6.
3.
The patient has evidence of clinically significant disease including but not limited to 
pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease or 
metabolic disturbance (patients with controlled diabetes, or patients with controlled 
hypertension, or right bundle branch block, complete or partial, may be included in the 
study). Patients with pacemakers are eligible provided that they will follow a routine 
check-up with their doctor and are considered stable. As specified in the donepezil SmPC
special precaution is needed for patients with asthma, obstructive pulmonary disease, 
bradycardia, or difficulty in passing urine.
4.
The patient has known fructose intolerance.
5.
The patient has had safety and tolerability issues with the prior use of memantine.
6.
The patient takes or has taken disallowed recent or concomitant medication (specified in
Appendix II) or it is anticipated that the patient will require treatment with at least one of 
the disallowed concomitant medications during the study.
7.
The patient’s donepezil or memantine treatment is likely to be interrupted or discontinued 
during the study.
8.
The patient has clinically significant abnormal vital signs at Visit 6 considered a potential 
safety risk by the Investigator.
9.
The patient has a moderate or severe on-going adverse event from the open-label 
treatment period (initial 28-week period) considered a potential safety risk by the 
investigator.
10. The patient has a previous history of testing positive for hepatitis B surface antigen 
(HBsAg), or hepatitis C virus / antibodies (anti-HCV) AND had abnormal ALT, AST or 
bilirubin during the open-label treatment period (initial 28-week period).
11. The patient has tested positive for hepatitis B surface antigen (HBsAg), or hepatitis C 
virus /antibodies (anti-HCV) for the first time within the last 6 months prior to Visit 6 in 
the open-label treatment period (initial 28-week period).
12. The patient has one or more clinical laboratory test values outside the reference range, 
based on the latest available blood and urine sample results available at Visit 6, that are of 
potential risk to the patient’s safety, or the patient has according to the latest available 
blood sample:

a serum creatinine value >1.5 times the upper limit of the reference range, or

a serum total bilirubin value >1.5 times the upper limit of the reference range, or

a serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value >2 
times the upper limit of the reference range
13. The patient has, based on the latest ECG available at Visit 6:

an abnormal ECG that is, in the investigator’s opinion, clinically significant, or 

a heart rate <45 beats per minute, or

a PR interval >280 ms, or

a QRS interval >150 ms, or

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
a QTcF interval >480 ms (based on the Fridericia correction where QTcF = 
QT/RR0.33) 
Patients with a heart rate between 45 and 49 beats per minute or a PR interval between 
250 and 280 ms, based on the latest ECG results, available at Visit 6, must be discussed 
with the sponsor medical expert before being enrolled. The patients can be considered 
eligible, provided they are stable and there is no safety risk related to their participation in 
the study as per the investigator's judgement.
14. The patient is, in the investigator’s opinion, unlikely to comply with the protocol, e.g., 
unable to complete all relevant assessments including the C-SSRS at Visit 6 or is 
unsuitable for any other reason (e.g., worsening of the patient’s dementia to the degree 
that a change in the patient’s residential status is warranted over the next 6 months).
15. The patient is likely to be placed in a nursing home during the study.
16. The patient has attempted suicide within the last year or is at significant risk of suicide 
(either in the opinion of the Investigator or defined as a “yes” to suicidal ideation 
questions 4 or 5 or answering “yes” to suicidal behaviour on the C-SSRS within the last 
12 months).
5.4
Withdrawal Criteria
A patient must be withdrawn from the study if:
• the patient and/or his or her legal representative withdraws his or her consent (defined as a 
patient and/or his or her legal representative  who explicitly takes back his or her consent);
section 8.3 states how the patient’s data will be handled.
• the investigator considers it, for safety and/or study compliance reasons, in the best 
interests of the patient that he or she be withdrawn.
• the patient has a serum ALT or AST value >8 times the upper limit of the reference range.*
(Not applicable for the Czech Republic)
• the patient has a serum ALT or AST value >5 times the upper limit of the reference range 
that is confirmed by testing within 5 days. (Applicable for the Czech Republic only)
• the patient has a serum ALT or AST value >3 times the upper limit of the reference range 
and a serum total bilirubin value >2 times the upper limit of the reference range.*
• the patient has a serum ALT or AST value >3 times the upper limit of the reference range 
and an international normalised ratio of prothrombin time (INR) more than 1.5.*
• the patient has a serum ALT or AST value >5 times the upper limit of the reference range 
for >2 weeks.* (Not applicable for the Czech Republic)
• the patient has a serum ALT or AST value >3 times the upper limit of the reference range 
with the appearance of fatigue, nauseas, vomiting, right upper quadrant pain or tenderness, 
fever, rash, and/or eosinophilia (>5%).*
• the patient has a QTcF interval >500 ms that is confirmed with an ECG taken at a
visit <2 weeks later.
• the patient attempts suicide or is at significant risk of suicide ( either in the opinion of the 
investigator or defined as a “yes” to suicidal ideation questions 4 or 5 or answering “yes” 
to suicidal behaviour on the C-SSRS during the study).

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• the patient is lost to follow-up (defined as a patient who fails to comply with scheduled 
study visits or contact, who has not actively withdrawn from the study, and for whom no 
alternative contact information is available [this implies that at least two attempts have 
been made to contact the patient]).
* in accordance with the FDA "Guidance for Industry Drug-Induced Liver Injury: 
Premarketing Clinical Evaluation”5
Patients who withdraw will not be replaced.
6
Investigational Medicinal Products
6.1
Treatment Regimen
Open-label treatment period (initial 28-week period):
All patients will be treated with idalopirdine 60 mg/day (IMP) and donepezil hydrochloride 
(10 mg/day).
The daily dose of idalopirdine 60 mg/day can be decreased to 30 mg/day if it is not well 
tolerated by the patient in the opinion of the investigator (see section 8.6).
The IMP will be dispensed as adjunctive treatment to the base treatment with donepezil 
hydrochloride.
Visit 1: The patient will be dispensed one wallet card of idalopirdine 60 mg encapsulated 
tablets and one wallet card of donepezil hydrochloride 10 mg tablets.
Visit 2-3: The patient will be dispensed one wallet card of idalopirdine 60 mg or 30 mg 
encapsulated tablets and one wallet card of donepezil hydrochloride 10 mg tablets. 
Visit 4-5: The patient will be dispensed two wallet cards of idalopirdine 60 mg or 30 mg
encapsulated tablets, and two wallet cards of donepezil hydrochloride 10 mg tablets.
The patients will be instructed to take 1 capsule of IMP once daily and 1 tablet of donepezil 
hydrochloride 10 mg once daily, for oral use. The first dose of the IMP and donepezil 
hydrochloride 10 mg is to be taken the day after dispensing to the patient. The dose of 
donepezil hydrochloride must be maintained throughout the duration of the study.
Open-label treatment period with memantine (substudy):
All patients will be treated with the same dose of IMP idalopirdine used in the open-label 
treatment period (initial 28-week period), donepezil hydrochloride 10 mg/day and memantine 
(patient’s individualised dose; including titration doses).

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Memantine (patient’s individualised maintenance dose) should be prescribed according to the 
investigator's judgement and the initial dose may be changed at any time if clinically indicated 
in the opinion of the investigator. The dose of donepezil hydrochloride must be maintained 
throughout the duration of the study. The dose of idalopirdine must remain fixed at that the 
dose given at the end of the open-label treatment period (initial 28-week period). The 
investigator should ensure that the memantine prescribed to the patient is an approved brand 
for their country and that an adequate supply of memantine is prescribed for the time between 
any two visits. 
The IMP and memantine will be dispensed as adjunctive treatment to donepezil hydro-
chloride.
Visit 6, 8-10: Memantine will be prescribed according to the investigator’s judgement 
(patient’s individualised dose after titration period) and investigator should ensure that an 
adequate supply of memantine is prescribed for the patient between any two visits.
Visit 6, 8 and 9: The patient will be dispensed one wallet card of idalopirdine 60 mg or 30 mg 
encapsulated tablets, one wallet card of donepezil hydrochloride 10 mg tablets.
Visit 10: The patient will be dispensed three wallet cards of idalopirdine 60 mg or 30 mg 
encapsulated tablets, three wallet cards of donepezil hydrochloride 10 mg tablets. 
The patient will be instructed to take 1 capsule of IMP once daily, 1 tablet of donepezil 
hydrochloride 10 mg once daily, for oral use, and memantine as prescribed by the 
investigator. The first dose of IMP, and donepezil hydrochloride 10 mg, and memantine is to 
be taken the day after Visit 6. For the day of Visit 6, patient will take IMP and donepezil from 
wallet cards that they return and will start new wallet cards the day after Visit 6.
The patient should continue to take memantine from the same supply brought to the visit (for 
accountability) until the package is empty. The investigator must ensure a new prescription 
for memantine is provided if there is not enough medication for the treatment days until the 
next visit including the potential visit window.

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Panel 4
Dose Schedules
IMP Dispensing
Week     Day/Visit
Treatment Group        
Base treatment                             
Idalopirdine 
30 mg or 60 mg/day
Donepezil hydrochloride
10 mg/day
Memantine a, b
(patient’s individualised 
dose
Week 1     Day 0/ Visit 1
  60 mg
10 mg
NA
Week 4     Day 28/Visit 2
30 mg or 60 mg
10 mg
NA
Week 8     Day 56/Visit 3
30 mg or 60 mg
10 mg
NA
Week 12   Day 84/Visit 4
30 mg or 60 mg
10 mg
NA
Week 20   Day 140/Visit 5
30 mg or 60 mg
10 mg
NA
Week 28   Day 196/Visit 6a
30 mg or 60 mg
10 mg
titration dose
Week 32   Day 224/Visit 8a
30 mg or 60 mg
10 mg
maintenance dose
Week 36   Day 252/Visit 9a
30 mg or 60 mg
10 mg
maintenance dose
Week 40   Day 280/Visit 10a
30 mg or 60 mg
10 mg
maintenance dose
a  only for patients participating in the open-label treatment period with memantine (substudy)
b  memantine will be prescribed by the investigator or another medically-qualified person
6.2
IMPs, Formulations, and Strengths
Open-label treatment period (initial 28-week period):
The IMPs in this period are:
• Idalopirdine - 30 mg/day, once daily, encapsulated tablets, for oral use
• Idalopirdine - 60 mg/day, once daily, encapsulated tablets, for oral use
Base treatment provided by H. Lundbeck A/S in this study is:
• Donepezil hydrochloride - 10 mg/day, once daily, tablets, for oral use
Open-label treatment period with memantine (substudy):
The IMPs in this period are:
• Idalopirdine -  30 mg/day, once daily, encapsulated tablets, for oral use
• Idalopirdine -  60 mg/day, once daily, encapsulated tablets, for oral use
Base treatment provided by H. Lundbeck A/S in this study is:
• Donepezil hydrochloride - 10 mg/day, once daily, tablets, for oral use
Base treatment prescribed according to investigator judgement is:
• Memantine immediate-release (IR): 20 mg/day (recommended target dose) or patient’s 
individualised maintenance dose (including titration doses as applicable during an initial 
titration phase of up to 3 weeks); once daily or twice daily, tablets, for oral use.
• Memantine extended-release (XR): 28 mg/day (recommended target dose) or patient’s 
individualised maintenance dose (including titration doses as applicable during an initial 
titration phase of up to 3 weeks); once daily, capsules, for oral use.

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Memantine will not be supplied by Lundbeck, but should be prescribed according to approved 
SmPC/label by the investigator or another medically-qualified person.
6.3
Manufacturing, Packaging, Labelling, and Storage of IMP
The IMPs will be manufactured, packaged, labelled, released (by a qualified person [QP]), 
and distributed in accordance with the principles of Good Manufacturing Practice, under the 
responsibility of Lundbeck.
The donepezil hydrochloride tablets will be packaged, labelled, released (by a qualified 
person [QP]) and distributed in accordance with the principles of Good Manufacturing 
Practice, under the responsibility of Lundbeck.
The idalopirdine 30 mg and idalopirdine 60 mg will be provided in 4-week wallet cards
containing 28+7 capsules to account for the treatment period as per Panel 2, Panel 3 and
Panel 4.
The donepezil hydrochloride will be provided in 4-week wallet cards containing 28+7 tablets 
to account for the treatment period as per Panel 2, Panel 3 and Panel 4.
The wording on the labels will be in accordance with the Good Manufacturing Practice
guidelines regarding labelling and national and/or local regulatory requirements. If additional 
information is to be added when the IMP is dispensed to patients, this will be clearly stated on 
the labels, and the investigator will be instructed to do so.
No manipulation, repackaging, or relabelling of IMP or donepezil hydrochloride is permitted 
after QP release by Lundbeck, unless a repackaging/relabelling agreement exists, and the 
documentation is available to the Department of Clinical Supply, H. Lundbeck A/S, and, 
where necessary, new QP releases are made.
The IMP and donepezil hydrochloride will be identified using a unique IMP number.
Patients continuing into the open-label treatment period with memantine (substudy) will 
receive memantine (titration dose or patient’s individualised dose) as prescribed according to 
the Investigator’s judgement.
The IMP, donepezil hydrochloride and memantine must be stored in a safe and secure 
location, and in accordance with the storage conditions specified on the labels.
6.4
Dispensing of IMP
Open-label treatment period (initial 28-week period):
The number of days between two visits must not exceed the number of days for which the 
patient has been dispensed IMP and donepezil hydrochloride.

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Capsule and tablet counts will be done at each visit. The patients will be asked to return all 
wallet cards (used and unused) at each visit.
Open-label treatment period with memantine (substudy):
The number of days between two visits must not exceed the number of days for which the 
patient has been dispensed IMP, donepezil hydrochloride and prescribed memantine.
Capsule and tablet counts will be done at each visit. The patients will be asked to return all 
wallet cards (used and unused) for IMP and donepezil hydrochloride at each visit. In addition, 
patients will be asked to bring used and unused memantine in original packaging to the visit 
for accountability purposes.
6.5
Method of Assigning Patients to Treatment
The patient’s screening number from the lead-in study will automatically be transferred into 
the extension study.
An interactive voice response system (IVRS) will be used in this study. The IVRS will
dispense IMP idalopirdine 60 mg (or idalopirdine 30 mg in case of a tolerability issue) to the 
patients and donepezil hydrochloride 10 mg to the patients on base treatment with donepezil 
only.
6.6
IMP Accountability
The IMPs and donepezil hydrochloride must be tracked using two logs:
• a site-specific log to track the complete inventory (that is, what is shipped between the site 
and Lundbeck)
• a patient-specific log to track what is dispensed to and returned by the patient 
Open-label treatment period with memantine (substudy):
Memantine must be tracked using:
• a patient-specific log to track what is prescribed to, returned by and re-dispensed or re-
prescribed to the patient
The investigator and the pharmacist (if applicable) must agree to only dispense IMP and 
donepezil hydrochloride to patients enrolled in the study. The investigator or the pharmacist 
(if applicable) must maintain an adequate record of the receipt and distribution of the IMPs
and donepezil hydrochloride. This record must be available for inspection at any time.
For tracking of accountability, the used and unused wallet cards (IMP and donepezil 
hydrochloride) and prescribed memantine records should be available for verification of 
accountability data at any time.

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6.7
Post-study Access to IMP
Open-label treatment period (initial 28-week period):
The patients will not be provided with IMP or donepezil hydrochloride after study 
completion. The patient must be treated in accordance with normal clinical practice and may 
continue on donepezil hydrochloride as per prescription, if judged relevant by the 
investigator.
Open-label treatment period with memantine (substudy):
The patients will not be provided with IMP or donepezil hydrochloride after study 
completion. The patient must be treated in accordance with normal clinical practice and may 
continue on donepezil hydrochloride and/or memantine as per prescription, if judged relevant 
by the investigator.
7
Concomitant Medication
For patients in the open-label treatment period (initial 28-week period): Concomitant 
medication is any medication other than the IMP and donepezil that is taken during the study. 
For patients in the open-label treatment period with memantine (substudy): Concomitant 
medication is any medication other than the IMP, and donepezil and memantine that is taken 
during the study.
The concomitant medications that are disallowed during the study are summarised in
Appendix II.
Data on concomitant medications that are on-going at V7 (Completion Visit) of the lead-in
study will be transferred to the 14861B study. Any changes, including reason for the change,
in concomitant medication must be recorded at each subsequent visit. For any concomitant 
medication initiated or for which the dose has changed due to a new disorder or worsening of 
a concurrent disorder, the disorder must be recorded as an adverse event.
8
Study Visit Plan
8.1
Overview
An overview of the procedures and assessments to be conducted during the study and their 
timing is presented in Panel 2 and Panel 3. Further details are in chapter 9.
All assessments can be completed over a maximum of two consecutive days, in this case the 
first day should be considered as the visit day of the study.

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After completing or withdrawing from the study, the patient must be treated in accordance 
with usual clinical practice. 
8.2
Baseline II Visit /Visit 1 (Visit 7 of the lead-in study)
Baseline II Visit is the same visit as Visit 7 (Completion Visit) of the lead-in study and most 
of the data from assessments performed during Visit 7 (Completion Visit) will be transferred 
to study 14861B.
Laboratory and ECG results that are available at Visit 7 (Completion Visit) of the lead-in 
study will be used for eligibility assessment in study 14861B.
A written informed consent must be obtained before any assessments presented in Panel 2 for 
the Baseline II Visit is performed (with exception of the assessments performed in the lead-in 
study).
Assessments and procedures to be performed after the informed consent has been signed 
include evaluation of inclusion and exclusion criteria, dispense of Patient Identification Card
and IMP dispense.
Patient Identification Card
Each patient will be provided with a patient identification card that states, at a minimum, the 
name of the IMP, the study number, the patient identification number, the investigator’s 
name, and an emergency telephone number providing 24-hour service.
The patient identification card should be returned to the investigator upon completion of the 
patient’s participation in the study.
8.3
Baseline III Visit /Visit 6 [open-label treatment period with memantine
(substudy)]
Baseline III Visit of the open-label treatment period with memantine (substudy) is the same 
visit as Visit 6 of the open-label treatment period (initial 28-week period). Assessments and 
procedures done at Visit 6 in the open-label treatment period (initial 28-week period) are the 
same as the Baseline III Visit.
The most recent laboratory and ECG results that are available at Visit 6 will be used for 
eligibility assessment in the open-label treatment period with memantine (substudy).
A written informed consent must be obtained before any assessments presented in Panel 3 are 
performed (with exception of the assessments performed as a part of Visit 6).
Assessments and procedures to be performed after the informed consent has been signed 
include evaluation of inclusion and exclusion criteria, pharmacokinetic assessments and IMP 
and donepezil dispensing and memantine prescriptions.

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8.4
Withdrawal Visit
Patients who withdraw from the study prior to the Completion Visit will be asked to attend a 
Withdrawal Visit, if at all possible. The visit must be scheduled as soon as possible after 
withdrawal.
No new information will be collected from patients who withdraw, except information 
collected in relation to the scheduled Withdrawal Visit or needed for the follow-up of adverse 
events (section 10.5).
The reason for withdrawal must be recorded on the Reason for Withdrawal Form in the 
eCRF.
For a patient and/or his or her legal representative who withdraw(s) consent:
• if the patient and/or his or her legal representative withdraw(s) consent during a visit and 
then agrees to it being the final visit, the investigator will complete the visit as a With-
drawal Visit and all the data collected up to and including this visit will be used.
• if the patient and/or his or her legal representative (if applicable) withdraw(s) consent 
during a telephone conversation, the investigator will ask the patient if he or she will attend 
a Withdrawal Visit. If the patient:
agrees to attend a Withdrawal Visit, all the data collected up to and including this visit 
will be used.
refuses to attend a Withdrawal Visit, the investigator should attempt to follow the 
patient’s safety and future treatment.
• if the patient and/or his or her legal representative (if applicable) explicitly request(s) that 
his or her data collected from the time of withdrawal of consent onwards not be used, this 
will be respected.
8.5
Safety Follow-up Visit (Visit 7 and Visit 12)
The safety follow-up is conducted to capture serious adverse events (SAEs) that occur during 
the Safety Follow-up Period as well as to follow up on the outcome of adverse events on-
going at the end of the Treatment Period. The safety follow-up must be conducted as a visit to 
the site. 
Open-label treatment period (initial 28-week period):
For patients not continuing into the open-label treatment period with memantine (substudy), 
the safety follow-up (Visit 7) must be conducted 4 weeks (+ up to 7 days) after Visit 6 
(Completion/Withdrawal Visit). 
Open-label treatment period with memantine (substudy):
The safety follow-up (Visit 12) must be conducted 4 weeks (+ up to 7 days) after Visit 11 
(Completion/Withdrawal Visit).

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For adverse events that were on-going at the end of the Treatment Period and that resolved 
during the Safety Follow-up Period, the stop date must be recorded. For non-serious adverse 
events still on-going at the safety follow-up, the stop date must be recorded as “on-going”. 
SAEs must be followed until resolution or the outcome is known.
Patients with a clinical safety laboratory test value that was out-of-range at the Completion or 
Withdrawal Visit and judged clinically significant must be followed according to accepted 
medical standards for up to 4 weeks or until resolution of the abnormality, whichever comes 
first.
Patients with AST or ALT values >3 times ULN at the Completion or Withdrawal Visit 
should be followed until the values normalise or return to the Baseline I values or a diagnosis 
has been established (see sections 8.7 and 9.4.2). The results must be recorded in the eCRF
until the end of the study (see section 8.7).
The safety follow-up for patients who withdraw consent must be performed, if at all possible; 
any information obtained will be recorded in the patients´ medical records.
8.6
Unscheduled Visit (Dispensing Unscheduled Study Visit)
Applicable only to the open-label treatment period (initial 28-week period):
In case of a tolerability issue as per investigator’s assessment, the dose of idalopirdine can be 
decreased from 60 mg/day to 30 mg/day. This is allowed only once during the patient’s 
participation in the study and can only take place during one of already scheduled visits or a 
specific unscheduled study visit, called “Dispensing unscheduled study visit”, to which both 
the patient and the caregiver are present. 
At the “Dispensing unscheduled study visit” the investigator will collect information about 
the tolerability issue that is to be recorded as an adverse event and potential change in the 
concomitant medication. The patients will be asked to return the wallet card of idalopirdine
60 mg encapsulated tablets (used and unused) and will be dispensed a new wallet card of 
idalopirdine 30 mg encapsulated tablets.
8.7
End-of-study Definition
The end of the study for an individual patient is defined as the last protocol-specified contact 
with that patient. The overall end of the study is defined as the last protocol-specified contact 
with the last patient on-going in the study.
For any increased (abnormal) laboratory value still present at the time of the last study 
patient’s visit [i.e., Visit 7 for patients who do not continue into the open-label treatment 
period with memantine (substudy) or Visit 12 for patients who participate in the open-label 
treatment period with memantine (substudy)], no follow-up information will be collected 
within the eCRF. Investigators will however still be required to follow the patients according 
to normal clinical practice.

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9
Assessments
9.1
Baseline Procedures and Assessments
Demographics and Other Baseline Characteristics
As indicated in Panel 2, demographics and other baseline characteristics performed during the 
Screening/Baseline I Visit in the lead-in study will be transferred to the 14861B study,
provided the patient is found eligible and has signed the Informed Consent Form for the 
14861B study.
9.1.1
Use of Efficacy Assessments
• The following assessments will be used: MMSE – assessing the cognitive aspects of 
mental function
• ADAS-Cog – assessing cognitive impairment
• ADCS-CGIC – blinded assessment of clinical global impression of change
• ADCS-ADL23 − assessing activities of daily living
• NPI – assessing neuropsychiatric symptoms
The efficacy assessments will be administered in the local language. Only scales provided by
Lundbeck that have been validated in the language to which they have been translated will be
used in this study.
Detailed instructions on how to administer and score the efficacy assessments will be
provided to the site in a Rater Guideline.
The ADAS-Cog should preferably be the first efficacy assessment performed at each visit.
The same order of assessments should be used per patient at each visit.
Assessments done at Visit 7 (Completion Visit) of the lead-in study will be transferred and 
will not be completed at the Baseline II Visit. 
For patients continuing into the open-label treatment period with memantine (substudy), 
MMSE done at Visit 6 in the open-label treatment period (initial 28-week period) is the same 
as the Baseline III Visit.
9.1.1.1
Mini Mental State Examination (MMSE)
The MMSE6 is a test designed to assess the cognitive aspects of mental function. The test
assesses 11 cognitive areas: orientation (items for time and place), memory (items for
registration and recall), attention and calculation, language (items for naming, repetition,
comprehension, reading and writing) and visual construction (item for drawing). The items
are administered in the order listed and rated immediately. The score for each item is
dichotomous (1 = response is correct, 0 = response is incorrect). The total score of the items

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ranges from 0 to 30, where the higher scores indicate lower impairment of cognitive function.
An experienced clinician can use the MMSE after a short training session. 
It takes approximately 10 minutes to administer and score the MMSE. The MMSE will be 
administered in the local language. Only scales provided by Lundbeck that have been 
validated in the language to which they have been translated will be used in this study.
9.1.1.2
Alzheimer’s Disease Assessment Scale – cognitive sub-scale (ADAS-Cog)
The ADAS-Cog7 is a test designed to assess cognitive symptoms associated with AD and is 
devised to be sensitive to change. The ADAS-Cog consists of 11 items to assess the patients 
orientation, memory (word recall, recognition, and remembering instructions), language 
(spoken language ability, comprehension of the spoken language, word finding difficulty, 
naming objects and fingers, following commands), and praxis (ideational and constructional). 
The total score of the 11 items ranges from 0 to 70, with a lower score indicating lower 
cognitive impairment.
An experienced clinician can administer the ADAS-Cog after a short training session. It takes
20-35 minutes to administer and rate the ADAS-Cog.
9.1.1.3
Alzheimer’s Disease Cooperative Study – Clinical Global Impression of
Change (ADCS-CGIC)
The ADCS-CGIC8 is a semi-structured interview designed to assess clinically relevant
changes in patients with AD. The ADCS-CGIC interview is guided by probes covering 
cognition, behaviour, and social and daily functioning. The severity of the symptoms is based 
on answers from both the patient and the caregiver. A global clinical judgement of severity at 
baseline in the lead-in study is used as a reference for subsequent visit change scores and is 
rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). At subsequent 
visits, a global impression of change from 1 (marked improvement) to 7 (marked worsening) 
is rated in comparison to the baseline reference, which is in this study the baseline assessment 
performed in the lead-in study.
The ADCS-CGIC can be administered by an experienced clinician after a short training
session. It takes approximately 30 to 45 minutes to administer the ADCS-CGIC.
The ADCS-CGIC rater must be blinded to all other efficacy and safety assessments. Sites 
should make all efforts possible to ensure the blinding of the CGIC rater is respected. In case 
the ADCS-CGIC rater administers other scales to other patient(s), the rater must keep an up to 
date listing with the patient(s) identification (screening number) and the corresponding scales 
administered. This listing must be available in the investigator trial master file (TMF)
throughout the study.

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9.1.1.4
Alzheimer’s Disease Co-operative Society – Activities of Daily Living (ADCS-
ADL) Inventory
The ADCS-ADL23
9 is a standardised, clinician-rated inventory designed to assess activities of 
daily living (ADL) in patients with AD over a defined period. 
The ADCS-ADL23 consists of 23 items and is conducted with a caregiver or informant who is 
in close contact with the patient. Each item in the ADCS-ADL23 (for example, eating, 
walking, bathing) comprises a series of hierarchical sub-questions, ranging from the highest 
level of independent performance to a complete loss for each ADL. The total score of the 23 
items ranges from 0 to 78, with higher scores indicating less impairment.
The ADCS-ADL23 can be administered by an experienced clinician after a short training
session. It takes 30 to 45 minutes to administer and rate the ADCS-ADL23.
9.1.1.5
Neuropsychiatric Inventory (NPI)
The NPI10,11,12 is a 12-item structured interview with a caregiver designed to assess
behavioural disturbances in patients with dementia. The NPI comprises 10 behavioural and 2
neurovegetative items. Each item consists of a screening question and several sub-questions
which are rated no (not present) or yes (present). Each item is then rated for frequency (a 
4-point scale from 1 [occasionally] to 4 [very frequently]), severity (a 3-point scale from 1
[mild] to 3 [marked]), and caregiver distress (a 6-point scale from 0 [not at all] to 5 [very
severely or extremely]). The total score12items of the frequency and severity ratings range from 
0 to 144 and the total score12items of caregiver distress ranges from 0 to 60.
An experienced clinician can use the NPI after a short training session. It takes approximately
30 minutes to administer and score the NPI.
9.1.2
Rater Qualification
Only raters who have been trained and certified are allowed to rate patients in study 14861B. 
The documentation of training issued during the lead-in study covers the extension study
14861B and no additional documentation will be re-issued for existing raters.
Rater training and certification will be conducted by ePharmaSolutions.
9.1.3
For new raters joining the study
The ADAS-Cog and MMSE should only be administered by a rater having adequate
experience with patients with AD and administration of cognitive tests. The rater should be a 
neurologist, geriatrician, psychiatrist or (neuro-)psychologist involved in clinical practice. 
Any exceptions (including experienced study nurses) must be discussed and approved by a 
Lundbeck Scales Manager.

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The ADCS-CGIC, ADCS-ADL23 and NPI should only be administered by a rater having
adequate experience with patients with AD and administration of (semi-)structured 
interviews. The rater should be a neurologist, geriatrician, psychiatrist or (neuro-)psychologist 
involved in clinical practice. Any exceptions (including experienced study nurses) must be 
discussed and approved by a Lundbeck Scales Manager. Only raters who qualify on study-
specific Rater Certification Programme will be authorised to rate in the study. Documentation 
of training and certification will be delivered to raters for archiving in the investigator TMF. 
No patient must be rated before the documentation has been delivered.
For each individual patient, the same certified rater should preferably rate the patient
throughout the study. In case of unforeseen circumstances, certified back-up raters should be
available throughout the study. In case of temporary change of rater, the primary rater should 
take over rating the patient as soon as returned to the site. A hand-over between primary rater 
and back-up rater should be documented.
Exceptional situations must be discussed and approved by the Scales Manager.
9.2
Pharmacoeconomic Assessments
The following pharmacoeconomic assessments will be used:
Open-label treatment period (initial 28-week period):
• EQ-5D-3L (by proxy) – assessing quality of life
• RUD Lite – assessing healthcare resource utilisation
• Dependence scale – assessing dependence
Assessments done at Visit 7 (Completion Visit) of the lead-in study will be transferred and 
will not be completed at the Baseline II Visit except Dependence scale for patients from the 
lead-in study 14861A. This scale will be administered for the first time during the Baseline II 
Visit of the extension study.
Open-label treatment period with memantine (substudy):
• Patient’s current living accommodation (question extracted from the Resource Utilisation 
in Dementia – Lite (RUD-Lite))
• Dependency scale
Assessments and procedures done at Visit 6 in the open-label treatment period (initial 28-
week period) are the same as the Baseline III Visit.
9.2.1
EQ-5D-3L (proxy)
The EQ-5D-3L13 will be completed by the patient’s caregiver as a proxy for the patient.
The EQ-5D-3L is a patient-reported assessment designed to measure the patient’s wellbeing. 
It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and 
depression/anxiety) and a visual analogue scale (VAS) of the overall health state. Each 

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descriptive item is rated on a 3-point index ranging from 1 (no problems) to 3 (extreme 
problems) and a single summary index (from 0 to 1) can be calculated. The VAS ranges from 
0 (worst imaginable health state) to 100 (best imaginable health state). It takes approximately 
5 minutes to complete the EQ-5D-3L.
9.2.2
Resource Utilisation in Dementia (RUD) – Lite
The RUD Lite14 is a caregiver questionnaire designed to assess resources required for patients
with dementia. The RUD Lite consists of two sections: one about the caregiver (covering
caregiver demographics, time spent by the caregiver on assisting the patient with personal and
instrumental activities of daily living and supervision, and caregiver work status); and one
about the patient (covering the patients accommodation status and healthcare resource
utilisation). The RUD Lite can be administered by study-site staff. It takes approximately 
15 minutes to complete the RUD Lite.
9.2.3
Dependence scale
The Dependence scale15 is a clinician-rated scale designed to measure dependence as a health 
outcome measure in Alzheimer’s disease. The Dependence scale is a 13-item scale with 
questions on social and occupational functioning. Two questions are rated by frequency (No, 
Occasionally, Frequently) and the remaining questions have yes or no responses. The answers 
are used to derive a dependence level from 0 (no dependence) to 5 (complete dependence). 
The clinician interviews an informant who lives with or is well-informed about the patient’s 
day to-day activities. The Dependence scale can be rated by a clinician after a short training 
session. It takes approximately 15 minutes to complete the scale.
In this study the informant will be the patient’s caregiver.
The Dependence scale should be completed following the ADCS-ADL by the same rater.
9.3
Pharmacokinetic Assessments
Applicable only to open-label treatment period with memantine (substudy):
Venous (2 mL) blood samples for IMP analysis will be collected in EDTA tubes. The blood 
sampling and handling procedures are described in the study-specific Laboratory 
Specification Manual.
The blood samples will be analysed for idalopirdine as well as for memantine using analytical 
methods validated according to the FDA Guidance for Industry16 and the EMA Guideline on 
bioanalytical method validation.17
The bioanalysis will be performed by the Department of Bioanalysis, H. Lundbeck A/S. A 
bioanalytical protocol will be prepared by Lundbeck prior to initiation of the bioanalysis of 
the blood samples. If other metabolites are identified and considered significant, these may be 
included in an exploratory analysis.

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Selected samples will be subjected to incur sample re-analysis (ISR) as part of the in-study 
method validation of the applied bioanalytical method. PK results and ISR results will be 
clearly distinguished from each other in the bioanalytical study report that will be prepared by 
the Department of Bioanalysis, H. Lundbeck A/S.
Actual time, date of blood sampling and dosing history (that is, dose, date and time of last 
administration) of IMP and memantine will be recorded in the eCRF.
9.4
Safety Assessments
9.4.1
Adverse Events
The patients will be asked a non-leading question (for example, “how do you feel?”, “how 
have you felt since your last visit?”) at each visit. Adverse events (including worsening of 
concurrent disorders, new disorders, and pregnancies) either observed by the investigator or 
reported spontaneously by the patient will be recorded, and the investigator will assess the
seriousness and the intensity of the adverse event and its relationship to the IMP. Results from 
relevant tests and examinations, such as clinical safety laboratory tests, vital signs, and ECGs, 
or their corresponding conditions will also be recorded as adverse events if considered by the 
investigator to be clinically significant.
See chapter 10 for further information on adverse events.
9.4.2
Clinical Safety Laboratory Tests
Blood and urine sampling results for clinical safety laboratory tests performed at Visit 7 
(Completion Visit) of the lead-in study will be transferred and considered as the Baseline II 
Visit results.
For patients continuing into the open-label treatment period with memantine (substudy), 
assessments and procedures done at Visit 6 in the open-label treatment period (initial 28-week 
period) are the same as the Baseline III Visit.
The clinical safety laboratory tests are listed in Panel 5.

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Panel 5
Clinical Safety Laboratory Tests
Haematology
Livera
Urineb
B-haemoglobin
S-total bilirubin
B-total leucocyte count
S-conjugated bilirubin( only if total 
U-protein 
B-neutrophils (% of total leucocytes)
bilirubin is high abnormal)
U-glucose 
B-eosinophils (% of total leucocytes)
S-alkaline phosphatase (AP)
B-basophils (% of total leucocytes)
S-alanine aminotransferase (ALT)
U-blood
B-lymphocytes (% of total leucocytes)
S-aspartate aminotransferase (AST)
U-ketones 
B-monocytes (% of total leucocytes)
S-γ-glutamyl transferase (γGT)
B-thrombocyte count
Coagulation
Electrolytesa
P-INR
Lipidsa
S-sodium
aPTT
S-cholesterol (total) 
S-potassium
S-triglycerides (non fasting)
S-hydrogencarbonation(HC03-)
S-calcium (total)
Infection
S-C-reactive protein (CRP)
Metabolica
S-albumin
S-glucose (non fasting)
Kidneya
S-creatinine
S-urea nitrogen (BUN) 
B – blood; P – plasma; S – serum; U – urine 
a
Clinical chemistry
b
Microscopic examination (leukocytes, erythrocytes and casts) will be performed only if any of the urine
evaluations are abnormal.
Blood samples for the clinical safety laboratory tests will be collected as outlined in Panel 2
and Panel 3. The blood sampling and handling procedures are described in the study-specific
Laboratory Specification Manual.
The blood samples will be analysed at the central laboratory specified in Appendix III.
Urine samples will be collected and analysed at the central laboratory specified in Appendix 
III.
The investigator must review (initial and date) the results of the clinical safety laboratory tests 
as soon as possible after receipt of those results. Out-of-range values must be interpreted by 
the investigator with a comment of “not clinically significant” or “clinically significant” with 
a comment concerning the planned follow-up. Tests for clinically significant out-of-range 
values must be repeated, or an appropriate clinical follow-up must be arranged by the 
investigator and documented on the laboratory report, until the value has stabilised or until the 
value has returned to a clinically acceptable value (regardless of relationship to IMP). Any 
value that was out-of-range at the Completion or Withdrawal Visit and judged clinically 

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significant must be followed according to accepted medical standards for up to 4 weeks or 
until resolution of the abnormality, whichever comes first. Any out-of-range values, except 
for AST or ALT, followed after the last protocol-specified contact with the patient will be 
documented in the patient´s medical records.
Patients with AST or ALT values >3 times ULN at the Completion or Withdrawal Visit 
should be followed until the values normalise or return to the Baseline I values or a diagnosis 
has been established (see section 8.7). The results must be recorded in the eCRF until the end 
of the study (see section 8.7).
Patients with repeat testing (within 48-72 h) showing AST/ALT >3 times ULN should follow
“close monitoring” with:
• Repeating liver enzymes (AST, ALT, AP, GT) and serum bilirubin 2-3 times weekly. 
Frequency of re-testing can be decreased to once a week or less if abnormalities stabilise,
or the patient is withdrawn and the patient is asymptomatic. The follow-up laboratory tests
should preferably be taken at site and processed in the central laboratory. If this is not at all 
possible, local laboratories are accepted.
• Obtaining a more detailed history of symptoms and prior or concurrent diseases.
• Obtaining a history of concomitant drug use (including non-prescription medications and 
herbal and dietary supplement preparations), alcohol use, recreational drug use, and special
diets.
• Ruling out acute viral hepatitis types A, B, C, D, and E; autoimmune or alcoholic hepatitis; 
non-alcoholic steatohepatitis; hypoxic/ischemic hepatopathy; and biliary tract disease.
• Obtaining a history of exposure to environmental chemical agents.
• Obtaining additional tests to evaluate liver function, as appropriate (for example INR, 
direct bilirubin).
• Considering gastroenterology or hepatology consultations.
Clinically significant out-of-range values must be recorded as an adverse event on an Adverse 
Event Report Form.
The central laboratory will be notified by the sponsor when the biological samples may be 
destroyed. 
9.4.3
Vital Signs
Please refer to Panel 2 and Panel 3 for time-points of assessments.
Assessments done at Visit 7 (Completion Visit) of the lead-in study will be transferred and 
considered as the Baseline II Visit results. 
For patients continuing into the open-label treatment period with memantine (substudy), 
assessments and procedures done at Visit 6 in the open-label treatment period (initial 28-week 
period) are the same as the Baseline III Visit.

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Blood pressure (BP) and pulse rate will be measured using a standard digital meter after the 
patient has rested for at least 5 minutes in a supine position. The patient must then be 
instructed to change from a supine to a standing position in a manner consistent with his/her 
normal routines and that includes passing through a sitting position before assuming an 
upright position. BP and pulse rate will be measured after the patient has been standing for at 
least 1 minute but no longer than 5 minutes. 
Measurements are to be obtained for a specific patient in the same manner (preferably from 
the same arm) throughout the study. Care should be taken to avoid stressful stimuli such as 
blood sampling immediately prior to measurements.
Abnormalities of clinical significance must be recorded as an adverse event on an Adverse 
Event Report Form.
9.4.4
Weight
Assessment done at Visit 7 (Completion Visit) of the lead-in study will be transferred and 
considered as the Baseline II Visit result. 
For patients continuing into the open-label treatment period with memantine (substudy), 
assessments and procedures done at Visit 6 in the open-label treatment period (initial 28-week 
period) are the same as the Baseline III Visit.
The patients will be weighed wearing light clothing and no shoes. A similar amount of 
clothing must be worn on each occasion.
Abnormalities of clinical significance must be recorded as an adverse event on an Adverse 
Event Report Form.
9.4.5
Electrocardiograms (ECGs)
Assessment done at Visit 7 (Completion Visit) of the lead-in study will be transferred and 
considered as the Baseline II Visit result.
For patients continuing into the open-label treatment period with memantine (substudy), 
assessments and procedures done at Visit 6 in the open-label treatment period (initial 28-week 
period) are the same as the Baseline III Visit.
A standard 12-lead electronic ECG (eECG) will be performed using digital ECG recording 
equipment provided to the investigator or, upon agreement, to an external cardiology centre.
The eECGs will be transferred digitally to a central ECG laboratory for evaluation. The
investigator will be provided with the results and a cardiological interpretation of the ECG
from the central ECG laboratory.

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Twelve-lead ECGs will be recorded at as specified in Panel 2 and Panel 3. ECG recordings 
will be obtained after the patient has been supine and at rest for at least 5 minutes. The ECG 
will be repeated in case of the central reader judge it as unreadable.
A manual covering all relevant procedures for ECG recording will be provided to the sites.
The investigator has the final decision on the clinical significance of ECG abnormalities other
than those described in: Exclusion criterion 10 or withdrawal criterion: “the patient has a
QTcF interval >500 ms that is confirmed by an ECG at a visit <2 weeks later.
Abnormalities of clinical significance must be recorded as an adverse event on an Adverse 
Event Report Form.
9.4.6
Physical and Neurological Examinations
The physical and neurological examinations done at Visit 7 (Completion Visit) in the lead-in 
study will be transferred and considered as the Baseline II Visit results.
For patients continuing into the open-label treatment period with memantine (substudy), 
assessments and procedures done at Visit 6 in the open-label treatment period (initial 28-week 
period) are the same as the Baseline III Visit.
The physical examination must, at a minimum, include an examination of appearance, 
extremities, skin, head, neck, eyes, ears, nose, throat, lungs, chest, heart, abdomen (including 
the renal regions) and musculoskeletal system and must be performed by a physician.
The neurological examination comprises an evaluation of cranial nerves, motor system, 
sensory system, reflexes, cerebellar function and gait and must be performed by a physician.
Abnormalities of clinical significance must be recorded as an adverse event on an Adverse 
Event Report Form.
The investigator may appoint a designee to be primarily responsible for performing the 
physical examination. If the appointed designee is to perform the physical examination, 
he/she must be permitted to do so according to local regulations and the investigator must 
take responsibility for reviewing the findings. Whenever possible, the same individual should 
perform all the physical examinations.
9.4.7
Columbia Suicide Severity Rating Scale (C-SSRS)
C-SSRS18 done at Visit 7 (Completion Visit) of the lead-in study will be transferred and will 
not be repeated at the Baseline II Visit. 
For patients continuing into the open-label treatment period with memantine (substudy), 
assessments and procedures done at Visit 6 in the open-label treatment period (initial 28-week 
period) are the same as the Baseline III Visit.

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The C-SSRS is a semi-structured interview developed to systematically assess suicidal
ideation and behaviour of patients participating in a clinical study. The C-SSRS has 5
questions addressing suicidal ideation, 5 sub-questions assessing the intensity of ideation, and
4 questions addressing suicidal behaviour. Different versions of the scale are available: in this 
study the ”Since last visit” version will be used at all visits. An experienced clinician can use 
the CSSRS after a short training session. It takes approximately 5 minutes to administer and 
rate the C-SSRS.
The C-SSRS should be rated by a neurologist, geriatrician, psychiatrist or (neuro-)
psychologist involved in clinical practice. Any exceptions must be discussed and approved by
a Lundbeck Scales Manager.
Only raters who have been trained and certified are allowed to rate patients in study 14861B. 
The documentation of training issued during the lead-in study covers the extension study 
14861B and no additional documentation will be re-issued for existing raters.
New raters joining the study will be trained and certified by ePharmaSolutions using the same 
certification procedure as in the lead-in study. For each individual patient, the same certified 
rater should rate the patient throughout the study. In case of unforeseen circumstances, 
certified back-up raters should be available throughout the study.
Exceptional situations must be discussed and approved by the Scales Manager.
9.5
Total Volume of Blood Drawn and Destruction of Blood
Open-label treatment period (initial 28-week period):
The total volume of blood drawn from each patient will be approximately 41 mL during the 
study.
Additional blood samples may be required if the original blood samples are not viable or if re-
testing is required.
The blood samples will be destroyed after completion of the analysis.
Open-label treatment period with memantine (substudy):
The total volume of blood drawn from each patient will be approximately 84 mL during the 
study, which includes 41 mL from the open-label treatment period (initial 28-week period) 
and 43 mL from the open-label treatment period with memantine (substudy).
Additional blood samples may be required if the original blood samples are not viable or if re-
testing is required.
The blood samples will be destroyed after completion of the analysis.

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The blood sampling for idalopirdine and memantine will be retained at the bioanalytical 
facility until the results have been reported. The samples will subsequently be destroyed by 
the responsible analytical laboratory. The bioanalytical lab will retain the samples until the 
bioanalytical report is final and no longer than 1 year from last patient last visit. Lundbeck
will be notified that the samples are to be destroyed, and the documentation for sample 
destruction will be kept in the bioanalytical study file.
9.6
Patient Compliance
Responsible study personnel will dispense wallet cards containing IMP (idalopirdine) and 
donepezil hydrochloride. Additionally, for patients participating in the open-label treatment 
period with memantine (substudy), memantine will be prescribed according to investigator 
judgement. Accountability and compliance verification should be documented in the patient’s
source documents and verified by the Clinical Research Associate (CRA) during monitoring. 
Patients must be counselled at each visit on the importance of taking the IMP, donepezil and 
memantine as directed.
10 Adverse Events
10.1
Definitions
10.1.1
Adverse Event Definitions19
Adverse event – is any untoward medical occurrence in a clinical study patient administered a 
pharmaceutical product and which does not necessarily have a causal relationship with this 
treatment.
An adverse event can, therefore, be any unfavourable and unintended sign (for example, an 
out-of-range laboratory value), symptom, or disease temporally associated with the use of a 
pharmaceutical product, regardless of whether it is considered related to the pharmaceutical
product.
It is Lundbeck policy to collect and record all adverse events, including pre-treatment adverse 
events, that is, those that start after the patient has signed the Informed Consent Form and 
prior to the first dose of IMP.
Serious adverse event (SAE) – is any adverse event that:
• results in death
• is life-threatening (this refers to an event in which the patient was at risk of death at the 
time of the event; it does not refer to an event that hypothetically might have caused death 
had it been more severe)
• requires inpatient hospitalisation or prolongation of existing hospitalisation
• results in persistent or significant disability/incapacity
• is a congenital anomaly/birth defect

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• is medically important (this refers to an event that may not be immediately life-threatening 
or result in death or hospitalisation, but may jeopardise the patient or may require interven-
tion to prevent any of the SAEs defined above)
Examples of medically important events are intensive treatment in an emergency room for 
allergic bronchospasm or blood dyscrasia, convulsions that do not result in hospitalisation, 
development of drug dependency, and drug abuse.
Planned hospitalisations or surgical interventions for a condition that existed before the 
patient signed the Informed Consent Form and that did not change in intensity are not SAEs. 
Emergency room visits that do not result in admission to the hospital are not necessarily 
SAEs; however, they must be evaluated to determine whether they meet any of the SAE 
definitions (for example, life-threatening or other serious [medically important] event).
Non-serious adverse event – is any adverse event that does not meet the definition of an SAE.
If there is any doubt as to whether an adverse event meets the definition of an SAE, a 
conservative viewpoint must be taken, and the adverse event must be reported as an SAE.
Suspected unexpected serious adverse reaction (SUSAR) – is any adverse event that is
assessed as serious, unexpected (its nature or intensity is not consistent with the current 
version of the Investigator’s Brochure1, and related to an investigational product by either the 
investigator or the sponsor.  
Overdose – is a dose taken by a patient that exceeds the dose prescribed to that patient. Any
overdose (and associated symptoms) has, at a minimum, to be recorded as a non-serious 
adverse event. The nature of the overdose must be clarified (for example, medication error, 
accidental overdose, or intentional overdose).
10.1.2
Adverse Event Assessment Definitions
Assessment of Intensity
The investigator must assess the intensity of the adverse event using the following definitions, 
and record it on the Adverse Event Report Form:
• Mild – the adverse event causes minimal discomfort and does not interfere in a significant 
manner with the patient’s normal activities.
• Moderate – the adverse event is sufficiently uncomfortable to produce some impairment of 
the patient’s normal activities.
• Severe – the adverse event is incapacitating, preventing the patient from participating in his 
or her normal activities.

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Assessment of Causality
The investigator must assess the causal relationship between the adverse event and the IMP 
using the following definitions, and record it on the Adverse Event Report Form and the 
Serious Adverse Event Report Form (if applicable):
• Probable – the adverse event has a strong temporal relationship to the IMP or recurs on 
rechallenge, and another aetiology is unlikely or significantly less likely.
• Possible – the adverse event has a suggestive temporal relationship to the IMP, and an 
alternative aetiology is equally or less likely.
• Not related – the adverse event has no temporal relationship to the IMP or is due to 
underlying/concurrent illness or effect of another drug (that is, there is no causal relation-
ship between the IMP and the adverse event).
An adverse event is considered causally related to the use of the IMP when the causality 
assessment is probable or possible.
For pre-treatment adverse events, a causality assessment is not relevant.
Assessment of Outcome
The investigator must assess the outcome of the adverse event using the following definitions, 
and record it on the Adverse Event Report Form and the Serious Adverse Event Report Form
(if applicable):
• Recovered – the patient has recovered completely, and no symptoms remain.
• Recovering – the patient’s condition is improving, but symptoms still remain.
• Recovered with sequelae – the patient has recovered, but some symptoms remain (for 
example, the patient had a stroke and is functioning normally, but has some motor impair-
ment).
• Not recovered – the patient’s condition has not improved and the symptoms are unchanged 
(for example, an atrial fibrillation has become chronic).
• Death
10.2
Pregnancy
If the partner of a man participating in the study becomes pregnant, the outcome of the 
pregnancy should be followed, if the partner agrees.
10.3
Recording Adverse Events
Adverse events (including pre-treatment adverse events) must be recorded on an Adverse 
Event Report Form. The investigator must provide information on the adverse event, 
preferably with a diagnosis, or at least with signs and symptoms; start and stop dates (and 
start and stop time if the adverse event lasts less than 24 hours); intensity; causal relationship 
to IMP; action taken; and outcome. If the adverse event is an overdose, the nature of the 

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overdose must be stated (for example, medication error, accidental overdose, or intentional 
overdose). If the intensity changes during the course of the adverse event, this must be 
recorded on the AE Intensity Log.
If the adverse event is serious, this must be indicated on the Adverse Event Report Form. 
Furthermore, the investigator must fill out a Serious Adverse Event Report Form and report 
the SAE to Lundbeck immediately after becoming aware of it (section 10.4).
Adverse events, including clinically significant out-of-range clinical safety laboratory values, 
must be recorded individually, except when considered manifestations of the same medical 
condition or disease state; in such cases, they must be recorded under a single diagnosis.
10.4
Reporting Serious Adverse Events
The investigator must report SAEs to Lundbeck immediately, and under no circumstances 
should this exceed 24 hours after becoming aware of them by completing a Serious Adverse
Event eCRF Form in Rave®.
The initial report must contain as much information as possible and, if more information 
about the patient’s condition becomes available, the Serious Adverse Event eCRF Form must 
be updated with the additional information.
If the investigator cannot report the SAE in Rave®, then he or she must complete and sign the 
Serious Adverse Event Fallback Form and send it to:
Global Pharmacovigilance (GPV)
Fax: +45 36 30 99 67
e-mail: safety@lundbeck.com
The initial report must contain as much information as possible and, if more information 
about the patient’s condition becomes available, a follow-up report with the additional 
information must be submitted using the same procedures and timelines as those for the initial 
report.
The signed (original) Serious Adverse Event Report Form must be collected by the CRA and 
filed in the sponsor TMF.
Lundbeck will assume responsibility for reporting SUSARs to the authorities in accordance 
with local regulations. In those Member States of the European Union that have implemented 
the European Union Clinical Trials Directive20 and in Norway, Liechtenstein, and Iceland, 
that is, in the countries where unblinded expedited safety reporting is required, Lundbeck will 
also assume responsibility for reporting SUSARs to the ethics committees.
Lundbeck will assess expectedness and inform the investigators about SUSARs via the 
monthly, blinded line listings or in accordance with local requirements. In the countries where 
unblinded expedited reporting is not required, it is thereafter the investigator’s responsibility 

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to report blinded SUSARs to the ethics committee, unless otherwise stated and documented 
by the ethics committee.
Lundbeck will assume responsibility for familiarising itself with local requirements regarding 
reporting SAEs to the IEC or IRB and acting accordingly.
It is the investigator’s responsibility to be familiar with local requirements regarding reporting 
SAEs to the IEC or IRB and to act accordingly.
10.5
Treatment and Follow-up of Adverse Events
Patients with adverse events must be treated according to usual clinical practice at the 
discretion of the investigator.
Non-serious adverse events must be followed up until resolution or the safety follow-up 
assessment, whichever comes first. At the safety follow-up, information on new SAEs, if any, 
and stop dates for previously reported adverse events must be recorded.
For follow-up of adverse events of safety laboratory tests (see section 9.4.2).
It is the responsibility of the investigator to follow up on all SAEs until the patient has 
recovered, stabilised, or recovered with sequelae, and to report to Lundbeck all relevant new 
information using the same procedures and timelines as those for the initial report. Relevant 
information includes discharge summaries, autopsy reports, and medical consultations.
SAEs that are spontaneously reported by a patient to the investigator after the safety follow-
up assessment must be handled in the same manner as SAEs that occur during the study. 
These SAEs will be captured in the GPV database.
Patients with clinically significant clinical laboratory values at the Completion or Withdrawal 
Visit must be followed in accordance with usual clinical practice and be scheduled for a 
Safety Follow-up Visit to allow for a medical examination and/or blood sampling (see 
section 8.5).
Patients who withdrew due to elevated AST or ALT values (see section 5.4) must be followed 
until the values normalise or stabilise or a diagnosis or a reasonable explanation has been 
established. Additional medical examinations (for example, ultrasound scanning and/or 
sampling for serology, conjugated bilirubin, INR) should be considered. A gastroenterology 
or hepatology consultation should also be considered.
10.6
Study Monitoring Committees
10.6.1
Data Monitoring Committee
The DMC consists of specialists within relevant therapeutic areas. The DMC ensures that the 
ethical principles are observed and monitors the safety of the patients. The DMC will be 

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informed to what extent the data and analyses provided to them have been quality controlled. 
Members of the DMC will not be involved in other study-related tasks. The DMC procedures 
are described in the Data Monitoring Committee Charter.
11 Data Handling and Record Keeping
11.1
Data Collection
11.1.1
Electronic Case Report Forms (eCRFs)
eCRFs will be used to collect all the data related to the study, except the external data 
described in section 11.1.3.
The eCRFs use third party software (Rave®) to capture data via an on-line system on a 
computer. Data related to the study will be recorded electronically in a central database over 
encrypted lines, and all entries and modifications to the data will be logged in an audit trail. 
Access to the system will only be granted after appropriate and documented training. Written 
instructions for using the system will be provided along with the training.
Electronic signatures will be used where signatures are required on pages and/or visits. 
Automated data entry checks will be implemented where appropriate; other data will be 
reviewed and evaluated for accuracy by the CRA. All entries, corrections, and changes must 
be made by the investigator or a delegate.
11.1.2
Patient Binders
11.1.2.1
Use of Patient Binders
Lundbeck will provide a Patient Binder for each patient.  The Patient Binder contains
different types of source documents, organised by visit and type. A ballpoint pen with 
waterproof ink must be used to enter information in the Patient Binder.
Data from the source documents should be recorded in the eCRF within 3 days of the patient 
visit.
11.1.2.2
Rating Scales and Caregiver Outcome 
The Patient Binder contains paper versions of the rating scales and caregiver outcomes. They 
will be completed by the rater(s) and caregiver, respectively. The data will be transcribed to 
the Scoring Sheets in the eCRF by the investigator or a delegate.
The rater(s) must verify that all the entries in the Scale Section are accurate and correct by 
signing and dating the relevant pages.

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Caregiver’s response cannot be corrected by the site staff.
11.1.2.3
Serious Adverse Event Fallback Forms
Serious Adverse Event Fallback Forms must be used when the eCRF cannot be accessed.
11.1.3
External Data
All electronic data will be transferred using a secure method accepted by Lundbeck.
The clinical safety laboratory results will be transferred by Quintiles Laboratories.
ECG results will be transferred by Quintiles Cardiac Safety Services.
11.2
Retention of Study Documents at the Site
11.2.1
eCRF Data
If a site closes before the study has been completed, the investigator will continue to have 
read-only access to the eCRF. If a site closes after the study has been completed, the 
investigator will no longer have read access to the eCRF. Instead, each site will be provided 
with a CD-ROM containing the data related to the site (including eCRF data, queries, and the 
audit trail). As a CD-ROM is not considered a durable medium and may therefore not be 
readable for the full retention period (for example, 15 years [if required by the applicable 
regulatory requirements]), it is possible for the investigator to request a new CD-ROM with 
the data related to the site.
11.2.2
Other Study Documents
The investigator must keep the investigator’s set of documents in the investigator TMF for at 
least 15 years after the Clinical Study Report has been approved or in accordance with 
national requirements, whichever is longer.
The Investigator will be requested to store the investigator TMF in a sealed archive box at an 
off site storage facility to ensure safe storage and easy retrieval of the study documents for the 
entire retention period. A study-specific binder will remain at the site after the other study-
specific documents have been shipped for off-site storage. This binder is considered part of 
the investigator TMF and must be kept in a secure place by the site for the required period of 
time. The binder must contain, at a minimum, the following documents: a copy of the
Investigator TMF Index, a certified copy of the Patient Identification Code List, and a
Retrieval Form.
Lundbeck will notify the investigator in writing when the required storage period has expired 
and when the documents may be destroyed according to regulations.

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12 Monitoring Procedures
Prior to including patients in the study, the investigator must sign a source data agreement that 
identifies the source documents (original documents, data, and records) at the site.
During the study, the CRA will visit the site to ensure that the protocol is being adhered to
and that all issues are being recorded, to perform source data verification, and to monitor IMP
accountability. The visit intervals will depend on the outcome of the remote monitoring of the 
eCRFs, the site’s recruitment rate, and the compliance of the site to the protocol and Good 
Clinical Practice.3  In addition, the CRA will be available for discussions by telephone.
Source data verification requires that the CRA be given direct access to all the source 
documents. Direct access includes permission to examine, analyse, verify, and reproduce any 
records and reports that are important for the evaluation of the study.
For all other data in the eCRFs, it must be possible to verify these against source documents.
13 Audits and Inspections
Authorised personnel from Global Clinical Quality Assurance at Lundbeck and quality 
assurance personnel from business partners may audit the study at any time to assess 
compliance with the protocol and the principles of Good Clinical Practice3 and all other 
relevant regulations.
The patients must be informed that authorised personnel from Lundbeck may wish to review
their medical records. The investigator must be aware and the patients must be informed that 
representatives from regulatory authorities may also wish to inspect source data, such as 
medical records.
The investigator must notify Lundbeck, without delay, of an announced inspection by a 
regulatory authority.
During audits and inspections, the investigator must permit direct access to all the source 
documents, including medical records and other documents pertinent to the study.
During audits and inspections, the auditors and inspectors may copy relevant parts of medical 
records. No personal identification apart from the screening or randomisation number will 
appear on these copies.
Patient data will not be disclosed to unauthorised third parties, and patient confidentiality will 
be maintained at all times.
14 Protocol Compliance
Deviations from the protocol must not occur.

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Lundbeck has a “no-waiver” policy, which means that permission will not be given to deviate 
from the protocol.
If deviations occur, the investigator must inform the CRA and they must review, discuss, and 
document the implications of the deviation.
15 Study Termination
Lundbeck or a pertinent regulatory authority may terminate the study or part of the study at 
any time. The reasons for such action may include, but are not limited to:
• safety concerns
• proven lack of efficacy of the IMP in other studies
If the study is terminated or suspended, the investigator must promptly inform the patients 
and ensure appropriate therapy and follow-up. Furthermore, the investigator and/or sponsor 
must promptly inform the IECs and IRBs and provide a detailed written explanation. The 
pertinent regulatory authorities must be informed in accordance with national regulations.
If the risk/benefit analysis changes after the termination of the study, the new evaluation must 
be provided to the IECs and IRBs if it will have an impact on the planned follow-up of the 
patients who participated in the study. If so, the actions needed to protect the patients must be 
described.
16 Statistical Methodology
16.1
Responsibilities
The Department of Biostatistics, H. Lundbeck A/S, will perform the statistical analyses
described below.
16.2
Analysis Sets
The following analysis sets will be used to analyse and present data:
• all-patients-treated set (APTS) – all patients who took at least one dose of IMP in the open 
label treatment period (initial 28-week period).
• all-patients-treated set 2 (APTS2) – all patients who took at least one dose of both IMP 
and memantine in the open-label treatment period with memantine (substudy).
Each patient will be classified according to this definition at a Classification Meeting held 
after all the data have been entered in the study database and verified.
All descriptive statistics and statistical analyses in the open-label treatment period (initial 28-
week period) will be based on the APTS, and all analyses in the open-label treatment period 

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with memantine (substudy) will be based on APTS2. Listings will be based on all patients 
entering the treatment period.
16.3
Descriptive Statistics
In general, summary statistics (n, arithmetic mean, standard deviation, median, lower and 
upper quartiles, minimum and maximum values) will be presented for continuous variables 
and counts and percentages will be presented for categorical variables.
Descriptive statistics will be presented for each treatment period separately.
Descriptive statistics for efficacy assessments (MMSE, ADAS-Cog, ADCS-ADL23, ADCS-
CGIC and NPI), Dependence scale, RUD Lite, and EQ-5D-3L will be presented by visit lead-
in study, and treatment group in the lead-in study and in total. For the open-label treatment 
period (initial 28-week period), data will be presented using data from both the lead-in study 
and the open-label treatment period (initial 28-week period). 
If relevant, individual patient profile plots will be generated for selected variables, using data 
from both the lead-in study and the extension study.
16.4
Patient Disposition
Patient disposition and reason for withdrawal will be presented by treatment period.
Patient disposition will be summarised by lead-in study, and by treatment group in the lead-in 
study and in total and include the number of patients who completed and the number of
patients who withdrew from the study.
The number of patients who withdraw from the study and primary reason for withdrawal as 
well as all reasons for withdrawal will be summarised by lead-in study, and treatment group 
in the lead-in study and in total. 
Kaplan-Meier time to withdrawal plots in the open-label treatment period (initial 28-week 
period) will be generated by lead-in study, and treatment group in the lead-in study and in 
total.
16.5
Demographics and Other Baseline Characteristics
Demographics (sex, age, race) based on APTS and APTS2 will be summarised by treatment 
group (placebo or idalopirdine all doses pooled) in the lead-in study and in total.
16.6
Recent and Concomitant Medication
Recent and concomitant medication in each treatment period will be summarised by 
anatomical therapeutic chemical (ATC) code and generic drug name by treatment group 
(placebo or idalopirdine all doses pooled) in the lead-in study and in total. 

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16.7
Exposure 
Exposure in each treatment period will be calculated per patient and summarised by treatment 
group (placebo or idalopirdine all doses pooled) in the lead-in study and in total. 
Number and percentage of patients with dose reduction of IMP to 30 mg/day in the open-label 
treatment period (initial 28-week period) will be calculated by treatment group (placebo or 
idalopirdine all doses pooled) in the lead-in study and in total. 
16.8
Efficacy Analyses
On an exploratory basis, changes from baseline in in the open-label treatment period (initial 
28-week period) of ADAS-Cog total score, ADCS-ADL23 total score, NPI total score, NPI 
individual items, EQ-5D-3L utility score, and EQ-5D-3L VAS score will be analysed using a 
restricted maximum likelihood (REML)-based mixed model for repeated measures (MMRM) 
approach. Baseline will be defined as the baseline in the lead-in study. The analyses will be 
performed by lead-in study. The model for the lead-in studies 14861A and 14862A will 
include the fixed categorical effects of treatment group in the lead-in study, country, visit, 
treatment-by-visit interaction, MMSE-stratum (<19, ≥19), and MMSE-stratum-by-visit 
interaction as well as the continuous covariates of baseline score and baseline score-by-visit 
interaction. In all analyses, an unstructured (co)variance structure will be used to model the 
within-patient errors. The Kenward-Roger approximation will be used to estimate 
denominator degrees of freedom. 
ADCS-CGIC will be analysed using the same methodology, using the scores at each visit and 
the ADCS-CGIC score at baseline in the lead-in study as baseline.
16.9
Safety Analyses
Safety tables will be presented for each treatment period separately by treatment group 
(placebo or idalopirdine all doses pooled) in the lead-in study, and in total.
16.9.1
Analysis of Adverse Events
Adverse events will be classified according to when the adverse event started:
• treatment-emergent adverse event (TEAE) – an adverse event that starts on or after the 
date of first dose of IMP in the extension study and prior to the last protocol-specified 
contact with that patient. TEAEs may be divided into study periods (these will be defined 
in the Statistical Analysis Plan).
Adverse events, sorted by system organ class (SOC) and preferred term, will be summarised 
by treatment group in the lead-in study and in total.
If relevant, incidence and prevalence in the lead-in study and in the open-label treatment 
period (initial 28-week period) for selected preferred terms will be presented by treatment 
group in the lead-in study.

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16.9.2
Analysis of Other Safety Endpoints
Clinical safety laboratory tests, vital signs, weight and ECG parameters will be summarised 
by visit and last post baseline assessment in the treatment period. For the open-label treatment 
period (initial 28-week period), the summaries will be presented using data from both the 
lead-in study and the open-label treatment period (initial 28-week period).
Potentially clinically significant (PCS) values will be flagged and summarised.
If relevant, individual patient profile plots will be generated for selected parameters, using 
data from both the lead-in study and the extension study.
C-SSRS will be summarised by visit. For the open-label treatment period (initial 28-week 
period), the summaries will be presented using data from both the lead-in study and the open-
label treatment period (initial 28-week period).
16.9.3
Analysis of Liver Tests
In addition to the standard summary of clinical safety laboratory tests, the incidences of
• ALT/AST > 1x, 1.5x, 2x, 3x, 5x, 10x, 20x ULN
• TBL > 1x, 1.5x, 2x ULN
• AP > 1.5x, 2x ULN
• ALT/AST > 3xULN and TBL > 2xULN
• ALT/AST > 3xULN and TBL > 2xULN and AP ≤ 1.5xULN
• ALT/AST > 3xULN and (TBL > 2xULN or INR > 1.5xULN) and AP ≤ 1.5xULN
will be produced.
16.10 Interim Analyses
An interim analysis may be performed prior to completion of the study to support a potential 
regulatory submission.
16.11 Sample Size and Power
Open-label treatment period (initial 28-week period):
Approximately 240 sites are planned in 30-35 countries. The study will include eligible 
patients who have completed Visit 7 (Completion Visit) of the lead-in studies. Assuming a 
completion rate of 85% and that approximately 85% of these are eligible and complete the 
extension study, this results in a total of approximately (3x310 + 3x280) x 85% x 85% ≈ 1280
patients completing this study. 
Open-label treatment period with memantine (substudy):

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With a sample size of n=100 the upper 1-sided 90% confidence limit for 0 to 10 AEs 
observed is:
Number of AEs 
observed
0
1
2
3
4
5
10
Upper 1-sided CI 
for AE incidence
2.3%
3.9%
5.3%
6.6%
7.9%
9.1%
15.0%
This is regarded as sufficient accuracy for evaluating safety and tolerability.
16.12 Statistical Analysis Plan
A Statistical Analysis Plan describing the handling of data issues and the planned statistical 
analyses in more detail will be prepared by the Department of Biostatistics, H. Lundbeck A/S, 
before any of the lead-in studies are unblinded.
17 Clinical Study Report and Publications
17.1
Clinical Study Report
Upon completion of the study, a Clinical Study Report will be prepared by the Department of 
Medical Writing, H. Lundbeck A/S.
17.2
Data Ownership
The data collected in this study are the property of Lundbeck.
17.3
Publications
The results of this study will be submitted for publication.
The primary publication based on this study must be published before any secondary 
publications are submitted for publication.
Authors of the primary publication must fulfil the criteria defined by the International 
Committee of Medical Journal Editors (ICMJE).21
18 Indemnity and Insurance
In the event of study-related injuries or deaths, insurance for the patients and indemnity of the 
investigators and those of their employees, servants, or agents whose participation in this 
study has been documented are provided. Insurance and liability will be in accordance with 
applicable laws and Good Clinical Practice.3

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19 Finance
19.1
Site Agreement
The financial agreements for the site are addressed in one or more documents.  Both parties 
must sign the agreements before the site is initiated.
19.2
Financial Disclosure
All the investigators, including sub-investigators and raters, participating in the study must 
complete a Financial Disclosure Form in order to comply with the United States Food and 
Drug Administration (FDA) Financial Disclosure requirements.
19.3
Equipment
Equipment owned or rented by Lundbeck that has been provided to the site for use during the 
study must be returned at the end of the study.

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References
1
H. Lundbeck A/S. Investigator’s Brochure: Lu AE58054. 12 June 2013 or later editions.
2
World Medical Association (WMA). Declaration of Helsinki: Ethical principles for medical 
research involving human subjects. [Internet] 
wma.net/en/30publications/10policies/b3/index.html.
3
ICH. ICH Harmonised Tripartite Guideline E6: Guideline for Good Clinical Practice. 1996.
4
European Parliament and the Council of the European Union. Directive 95/46/EC: Protection of 
individuals with regard to the processing of personal data and on the free movement of such data.  
24 October 1995.  Official Journal of the European Communities L 281, 23 November 1995, 
0031-0050.
5
United States Food and Drug Administration (FDA). Guidance for Industry: Drug-Induced Liver 
Injury: Premarketing Clinical Evaluation. July 2009.
6
Folstein MF, Folstein SE, McHugh PR. “Mini-mental state”: A practical method for grading the 
cognitive state of patients for the clinician. J. Psychiatr. Res. 1975; 12: 189-98.
7
Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer’s Disease. Am J. Psychiatry 
1984; 141, 11: 1356-64.
8
Schneider LS, Olin JT, Doody RS, Clark CM, Morris JC, Reisberg B, et al. Validity and 
reliability of the Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change. 
Alzheimer Dis Assoc Disord. 1997; 11(Suppl 2): 22-32.
9
Galasko D, Bennett D, Sano M, Ernesto C, Thomas R, Grundman M, et al. An inventory to assess 
activities of daily living for clinical trials in Alzheimer´s Disease. Alzheimer Dis Assoc Disord. 
1997; 11(Suppl 2): 33-9.
10
Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The 
neuropsychiatric inventory: comprehensive assessment of psyhopathology in dementia. 
Neurology. 1994; 44: 2308-14.
11
Cummings JL. The neuropsychianic inventory: assessing psychopathology in dementia patients. 
Neurology. 1997; 48(Suppl 6): 10-16.
12
Kaufer DI, Cummings JL, Christine D, Bray T, Castellon S, Masterman D, et al. Assessing the 
impact of neuropsychiatric symptoms in Alzheimer's disease: the Neuropsychiatric Inventory 
Caregiver Distress Scale. J Am Geriatric Soc. 1998; 46: 210-15.
13
The EuroQoL Group. EuroQol: a new facility for the measurement of health-related quality of 
Life. Health Policy. 1990; 16(3): 199-208.
14
Wimo A, Winblad B. Resource utilisation in dementia: RUD Lite. Brain Aging. 2003; 3: 48-59.
15
Stern Y, Albert SM, Sano M, Richards M, Miller L, Folstein M et al. Assessing patient 
dependence in Alzheimer’s disease. J Gerontol 1994; 49:M216-M222.
16
United States Food and Drug Administration (FDA). Guidance for Industry: Bioanalytical 
method validation. May 2001.

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17
European Medicines Agency (EMA). Committee for Medicinal Products for Human Use
(CHMP). Guideline on bioanalytical method validation. EMEA/CHMP/EWP/192217/2009. 21 
July 2011.
18
Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, et al. The Columbia-
Suicide Severity Rating Scale: initial validity and internal consistency findings from three 
multisite studies with adolescents and adults. Am J Psychiatry. 2011; 168: 1266-77
19
ICH. ICH Harmonised Tripartite Guideline E2A: Clinical safety data management: definitions 
and standards for expedited reporting. 1994.
20
European Parliament and the Council of the European Union. Directive 2001/20/EC: 
Approximation of the laws, regulations and administrative provisions of the Member States 
relating to the implementation of good clinical practice in the conduct of clinical trials on 
medicinal products for human use.  4 April 2001.  Official Journal of the European Communities 
L 121/34, 1 May 2001.
21
International Committee of Medical Journal Editors (ICMJE). Uniform requirements for 
manuscripts submitted to biomedical journals: ethical considerations in the conduct and reporting 
of research: authorship and contributorship. [Internet] icmje.org/ethical_1author.html.

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Appendix I
Clinical Study Protocol Authentication and Authorisation

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Clinical Study Protocol
Authentication and Authorisation
Study title:
An open-label extension study to evaluate the long-term safety and 
tolerability of Lu AE58054 as adjunctive treatment to donepezil in patients 
with mild-moderate Alzheimer's disease
Study No.:
14861B
Edition No.:
3.0
Date of edition:
16 June 2015
This document has been signed electronically.  The signatories are listed below.
Authentication
I hereby confirm that I am of the opinion that the ethical and scientific basis of this study is sound.
International study manager:
Clinical research scientist:
Head, Biostatistics:
Divisional Director, GPV:
Authorisation
I hereby confirm that I am of the opinion that the ethical and scientific basis of this study is sound.
Divisional Director, ICR 
Neurology:

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Appendix II
Recent and Concomitant Medication: Disallowed or 
Allowed with Restrictions

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Recent and Concomitant Medication: Disallowed or Allowed with 
Restrictions
In the table below disallowed recent and concomitant medications are listed, including any 
restrictions with respect to their use prior to and during the study.
Disallowed Recent and Concomitant Medication
Drug Class
Details
Any investigational drug
Disallowed throughout the whole study. 
AChE inhibitors or cholinergic 
agonists or antagonists
All AChE inhibitors except donepezil are disallowed.  Treatment with 
donepezil must have been stable at 10 mg/day and must be maintained 
throughout the duration of the study.
Anti-cholinergic drugs acting on 
the muscarinic acetylcholine 
receptor
Allowed only if prescribed for urinary and bladder difficulties, including 
frequent urination and inability to control urination. Dose modifications and 
initiation of treatment are disallowed during the study.
Anaesthetics:
General
Local
General anaesthetics are disallowed during the study except in case of 
emergency procedures requiring anaesthesia. 
Episodic use of local anaesthetics is allowed.
Analgesics  
Codeine and tramadol are allowed. Other opioid analgesics are disallowed 
during the study.
Anorexics
Disallowed during the study.
Antiacne agents
Disallowed during the study. 
Agents for topical use are allowed.
Antiarrhythmics
Open-label treatment period (initial 28-week period):
Flecainide and propafenone disallowed. For other antiarrhythmics dose 
modifications and initiation of treatment are allowed during the study. As 
specified in the donepezil SPC precaution should be taken when administering 
quinidine.
Open-label treatment period with memantine (substudy):
Flecainide, quinidine and propafenone disallowed. For other antiarrhythmics 
dose modifications and initiation of treatment are allowed during the study. 
Procainamide is allowed but caution should be exercised according to the 
memantine SmPC.
Antibiotics
Disallowed for chronic use during the study. 
UTI prophylaxis with antibiotics is allowed.
Anticoagulants
Low dose Low Molecular Weight Heparins for deep vein thrombosis 
prophylaxis are allowed. The anti-aggregation agents clopidogrel, or aspirin, 
or dipyridamole are allowed. Other anticoagulants are disallowed during the 
study.
Anticonvulsants
Disallowed if indication is epilepsy or convulsions.
Pregabalin is allowed for treatment of neuropathic pain. Gabapentin is allowed 
for treatment of neuropathic pain or essential tremor. Treatment must be well 
tolerated and the dose must have been stable during the study with no 
modification of the dose. Initiation of treatment during the study is disallowed. 
All other anti-epileptic agents are disallowed during the study, regardless of 
the indication.

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Drug Class
Details
Antidepressants
Stable treatment with no modification of dose with selective serotonin 
reuptake inhibitors (SSRIs), venlafaxine, moclobemide and mirtazapine for the 
duration of the study. Paroxetine and duloxetine should be used with caution. 
Initiation of treatment not allowed during the study. 
Trazodone (maximum evening dose of 50 mg) is acceptable if the treatment is 
stable.  Initiation and dose modification are not allowed during the study. 
Other antidepressants are disallowed. As specified in Section 4.5 of the 
donepezil SmPC precaution should be taken when administering fluoxetine.
Antidiarrhoeal agents
Allowed except opioid-containing agents.
Antifungal agents:
Systemic
Topical
Systemic antifungal agents are disallowed during the study. 
Antifungal agents for topical use are allowed.
Antihistamines
Only fexofenadine, (dex)loratidine and cetirizine allowed throughout the 
study.
Antihypertensives
Centrally active antihypertensives (such as clonidine, alphamethyldopa, 
guanidine, gaunfacine, moxonidine) are disallowed. For all other 
antihypertensives, dose modifications and initiation of treatment are allowed 
during the study.
Anti-impotence agents
Disallowed during the study.
Antinauseants
Occasional use for up to five consecutive days allowed.
Antineoplastics
Disallowed during the study.
Antiobesity agents
Disallowed during the study.
Anti-parkinson agents (e.g., 
levodopa, dopamine agonists, 
COMT inhibitors, amantadine, 
monoamine oxidase B 
inhibitors, anticholinergics etc)
Disallowed during the study.
Anti-psoriatic agents
Disallowed during the study. 
Anti-psoriatic agents for topical use are allowed.
Antipsychotics depot
Disallowed during the study.
Antipsychotics typical
Disallowed during the study.
Antipsychotics atypical
Only treatment with risperidone (maximum 2 mg/day) or quetiapine 
(maximum 100 mg/day) is allowed if absolutely necessary, and if prescribed 
according to treatment guidelines. Risperidone or quetiapine treatment should 
not be initiated within 3 days of a study visit with efficacy assessments. 
Antiviral agents
Anti-HIV agents are disallowed.
Anxiolytics
The use of benzodiazepines as anxiolytic treatment is acceptable, provided the 
dose remains fixed during the study. Where absolutely necessary, 
benzodiazepine treatment can be initiated as a short-term anxiolytic treatment 
during the study, as long as the treatment is not initiated within 3 days of a 
study visit with efficacy assessments.
Use of antidepressants is described in the corresponding row.
Benign prostate hyperplasia 
treatment
Only alpha-1 blockers (Terazosin, Tamsulosin, Doxazosin) and finasteride are 
permitted. 
Beta-blockers
Precaution should be taken when administering betablockers.
Cough/cold agents
Open-label treatment period (initial 28-week period):
Only non-opioids and codeine allowed.
Open-label treatment period with memantine (substudy):
Only non-opioids and codeine allowed. Dextromethorphan disallowed.
Diuretics
Open-label treatment period with memantine (substudy):
Hydrochlorothiazide and triamterene are disallowed.

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Drug Class
Details
H2 blocker/proton pump 
inhibitors
Open-label treatment period (initial 28-week period):
Dose modifications and initiation of treatment allowed during the study.
Open-label treatment period with memantine (substudy):
Dose modifications and initiation of treatment allowed during the study, but 
caution should be exercised according to the memantine SmPC.
Hormones, including hormone-
replacement therapy
Dose modifications and initiation of treatment allowed during the study. 
Steroids: See separate row.
Hormone suppressants
Dose modifications and initiation of treatment allowed during the study.
Hypoglycaemic agents and 
Insulin
Dose modifications and initiation of treatment allowed during the study. 
Rosiglitazone is disallowed. 
Hypolipidaemics
Dose modifications and initiation of treatment allowed during the study.
Muscle relaxants
Allowed on a p.r.n. basis (not to exceed 5 consecutive days).
As specified in Section 4.5 of the donepezil, rivastigmine and galantamine
SmPC precaution should be taken when administering neuro-muscular 
blockers.
NMDA-antagonist (memantine) Open-label treatment period (initial 28-week period):
Disallowed during the study. 
Open-label treatment period with memantine (substudy):
NMDA receptor antagonists, except for memantine, are disallowed (e.g., 
amantadine, dextromethorphan, ketamine).
Psychotropic agents, not 
otherwise specified (including 
herbal agents)
Disallowed during the study.
Gingko Biloba is allowed provided the dose remains fixed during the study.
Sedatives/
hypnotics
Zolpidem, zaleplon, and zopiclone: These selected hypnotics are acceptable 
provided the dose remains fixed during the study. Melatonin is allowed 
anytime. Where absolutely necessary, these agents may be initiated during the 
study as long as the treatment is not initiated within 3 days of a study visit with 
efficacy assessments. 
Please refer to Anxiolytics for benzodiazepines.
Steroids:
Systemic
Topical
Inhalant
Systemic steroids are disallowed during the study. 
Topical and inhalant use allowed before and throughout the study.
Urinary alkalinizers
Open-label treatment period with memantine (substudy):
Disallowed for patients participating in the open-label treatment period with 
memantine (substudy) (e.g. carbonic anhydrase inhibitors, sodium 
bicarbonate)

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Appendix III
Non-site Study Personnel and Vendors

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Non-site Study Personnel and Vendors
Coordinating Investigator
, Prof. Dr.  
Germany 
Tel
E-mail: 
Clinical Research Organisation (CRO) Responsible for Monitoring
Quintiles
Quintiles United Kingdom
575 East Swedesford Road Suite 200
Berkshire, RG2 6UU England
Tel: +44 (0) 1184 508000
Fax: +44 (0) 1344 708300
Primary contact:
Clinical research associate (CRA)
The CRA’s contact details are in the investigator TMF.
Sponsor & Sponsor Personnel 
H. Lundbeck A/S 
2500 Valby (Copenhagen), Denmark
+45 36 30 13 11
International study manager
Tel:
Medical expert
Tel
E-mail:
Vendors
Central laboratory
Quintiles Global Central Laboratories
The Alba Campus
Rosebank, Livingston
West Lothian, EH54 7EG
United Kingdom
Tel: +44 1506 81 4000
Fax: +44 1506 81 4199
Quintiles Laboratories Ltd
1600 Terrell Mill Road
Suite 100
Marietta, GA 30067
USA
Tel: +1 770 373 3500
Fax: +1 770 373 3501

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Central ECG Reader
Quintiles Cardiac Safety Services
Brigade South Parade, 1st Floor
No.10, M.G.Road
Bangalore – 560001
INDIA
Tel: + 91 80 6799 4917
Rater training and certification.
Data monitoring of scales
ePharmaSolutions
625 Ridge Pike
Suite E402 Building E
Conshohocken
PA 19428
USA
Tel: +1-800-503-9480
Electronic Data Capture
Medidata Solutions Worldwide
79 Fifth Avenue, 8th Floor
New York, New York 10003
USA
Tel: +1 212 918 1800
Fax: +1 212 918 1818
E-mail: helpdesk@mdsol.com
IVRS/IWRS
Almac Clinical Technologies
25 Fretz Road
Souderton, PA 18964
USA
Tel: +1 215 660 8500
Fax: +1 215 660 8620

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Appendix IV
Lead-in Study Treatment Designs

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Lead-in Study Treatment Designs
Study
IMP
Base treatment
14861A
Idalopirdine (30 mg)
Donepezil hydrochloride (10 mg)
Idalopirdine (60 mg)
PBO
14862A
Idalopirdine (10 mg)
Donepezil hydrochloride (10 mg)
Idalopirdine (30 mg)
PBO