Clinical trial NCT02006654: Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With an Acetylcholinesterase Inhibitor
Official title: Randomised, Double-blind, Parallel-group, Placebo-controlled Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With an Acetylcholinesterase Inhibitor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Disease
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2013-12-10
Enrollment: 734
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To establish efficacy of idalopirdine as adjunctive therapy to acetylcholinesterase inhibitors (AChEIs) for symptomatic treatment of patients with mild-moderate Alzheimer's disease (AD).

Detailed description: The study consisted of a screening period (up to 2-week period from screening to randomization), a 24-week double-blind treatment period with placebo or idalopirdine 60mg/day as adjunctive therapy to an acetylcholinesterase inhibitor (donepezil 10mg/day, rivastigmine at the patient's individual maintenance dose, or galantamine at the patient's individual maintenance dose), and a 4-week safety follow-up period following study completion or withdrawal from treatment. The dose could be decreased once during the study to 30mg/day if 60mg/day was not well tolerated in the opinion of the investigator. The dose could be increased again to 60mg/day, after which the dose was kept fixed for the remainder of the study. Dose changes were permitted until Week 12 (Visit 5).

Eligibility criteria: Inclusion Criteria:

* The patient has a knowledgeable and reliable caregiver.
* The patient is an outpatient.
* The patient has probable AD.
* The patient has mild to moderate AD.
* Stable treatment with an AChEI.
* The patient, if a woman, must have had her last natural menstruation ≥24 months prior to baseline, OR be surgically sterile.
* The patient, if a man, agrees to protocol-defined use of effective contraception if his female partner is of childbearing potential, OR must have been surgically sterilised prior to the screening visit.

Exclusion Criteria:

* The patient has evidence of any clinically significant neurodegenerative disease, or other serious neurological disorders other than AD.
* The patient has a Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) Axis I disorder other than AD.
* The patient has evidence of clinically significant disease.
* The patient's current AChEI therapy is likely to be interrupted or discontinued during the study.
* The patient is currently receiving memantine or has taken memantine within 2 months prior to screening.

Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Change in Cognition
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Change in Global Impression
timeFrame: Baseline and Week 24
measure: Change in Daily Functioning
timeFrame: Baseline and Week 24
measure: Change in Behavioural Disturbance
timeFrame: Baseline and Week 24
measure: Change in Individual Behavioural Disturbance Items
timeFrame: Baseline and Week 24
measure: Change in NPI Anxiety Item Score in Patients With an NPI Anxiety Item Score of at Least 2 at Baseline
timeFrame: Baseline and Week 24
measure: Clinical Improvement
timeFrame: Week 24
measure: Clinical Worsening
timeFrame: Week 24
measure: Change in Cognitive Aspects of Mental Function
timeFrame: Baseline and Week 24
measure: Change in Health-related Quality of Life (EQ-5D) Utility Score
timeFrame: Baseline and Week 24
measure: Change in Health-related Quality of Life (EQ-5D VAS)
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: Mesa
country: United States
facility: US612
state: Arizona
city: Bellflower
country: United States
facility: US625
state: California
city: Costa Mesa
country: United States
facility: US626
state: California
city: Oxnard
country: United States
facility: US604
state: California
city: Santa Ana
country: United States
facility: US627
state: California
city: Danbury
country: United States
facility: US609
state: Connecticut
city: Norwalk
country: United States
facility: US614
state: Connecticut
city: Deerfield Beach
country: United States
facility: US608
state: Florida
city: Hialeah
country: United States
facility: US616
state: Florida
city: Miami
country: United States
facility: US620
state: Florida
city: North Palm Beach
country: United States
facility: US603
state: Florida
city: Port Charlotte
country: United States
facility: US631
state: Florida
city: Elk Grove Village
country: United States
facility: US622
state: Illinois
city: Elkhart
country: United States
facility: US611
state: Indiana
city: Prairie Village
country: United States
facility: US606
state: Kansas
city: Farmington Hills
country: United States
facility: US601
state: Michigan
city: Saint Louis
country: United States
facility: US607
state: Missouri
city: Lawrenceville
country: United States
facility: US613
state: New Jersey
city: Manchester
country: United States
facility: US635
state: New Jersey
city: Toms River
country: United States
facility: US630
state: New Jersey
city: Albany
country: United States
facility: US621
state: New York
city: Staten Island
country: United States
facility: US632
state: New York
city: Charlotte
country: United States
facility: US633
state: North Carolina
city: Oklahoma City
country: United States
facility: US623
state: Oklahoma
city: Norristown
country: United States
facility: US618
state: Pennsylvania
city: Houston
country: United States
facility: US619
state: Texas
city: Caulfield
country: Australia
facility: AU603
city: Glen Iris
country: Australia
facility: AU609
city: Heidelberg West
country: Australia
facility: AU602
city: Kanwal
country: Australia
facility: AU604
city: Newcastle
country: Australia
facility: AU606
city: West Perth
country: Australia
facility: AU601
city: Woodville south
country: Australia
facility: AU610
city: Belo Horizonte
country: Brazil
facility: BR608
city: Itapira
country: Brazil
facility: BR609
city: Rio de Janeiro
country: Brazil
facility: BR607
city: Chocen
country: Czechia
facility: CZ602
city: Chocen
country: Czechia
facility: CZ608
city: Havlickuv Brod
country: Czechia
facility: CZ605
city: Kladno
country: Czechia
facility: CZ606
city: Plzen
country: Czechia
facility: CZ603
city: Prague
country: Czechia
facility: CZ601
city: Praha 10 - Strasnice
country: Czechia
facility: CZ607
city: Praha 6
country: Czechia
facility: CZ604
city: Bad Homburg
country: Germany
facility: DE612
city: Bad Honnef
country: Germany
facility: DE610
city: Berlin
country: Germany
facility: DE609
city: Berlin
country: Germany
facility: DE617
city: Erbach
country: Germany
facility: DE604
city: Freiburg
country: Germany
facility: DE611
city: Gelsenkirchen
country: Germany
facility: DE607
city: Homburg
country: Germany
facility: DE605
city: Karlstadt
country: Germany
facility: DE608
city: Mittweida
country: Germany
facility: DE602
city: Munich
country: Germany
facility: DE601
city: Rostock
country: Germany
facility: DE606
city: Ulm
country: Germany
facility: DE603
city: Unterhaching
country: Germany
facility: DE616
city: Bat Yam
country: Israel
facility: IL605
city: Haifa
country: Israel
facility: IL601
city: Holon
country: Israel
facility: IL604
city: Ramat Gan
country: Israel
facility: IL602
city: Tel Aviv
country: Israel
facility: IL603
city: Seongnam-si
country: Korea, Republic of
facility: KR601
city: Seoul
country: Korea, Republic of
facility: KR602
city: Seoul
country: Korea, Republic of
facility: KR603
city: Seoul
country: Korea, Republic of
facility: KR604
city: Mexico
country: Mexico
facility: MX602
city: Monterrey
country: Mexico
facility: MX601
city: Monterrey
country: Mexico
facility: MX603
city: Monterrey
country: Mexico
facility: MX604
city: Monterrey
country: Mexico
facility: MX605
city: Saltillo
country: Mexico
facility: MX606
city: Belgrade
country: Serbia
facility: RS602
city: Kragujevac
country: Serbia
facility: RS603
city: Novi Sad
country: Serbia
facility: RS601
city: Singapore
country: Singapore
facility: SG601
city: Singapore
country: Singapore
facility: SG602
city: Banska Bystrica
country: Slovakia
facility: SK601
city: Bratislava
country: Slovakia
facility: SK603
city: Bratislava
country: Slovakia
facility: SK605
city: Rimavska Sobota
country: Slovakia
facility: SK604
city: Svidnik
country: Slovakia
facility: SK602
city: Barcelona
country: Spain
facility: ES601
city: Barcelona
country: Spain
facility: ES603
city: Barcelona
country: Spain
facility: ES604
city: Barcelona
country: Spain
facility: ES608
city: Bilbao
country: Spain
facility: ES611
city: Burgos
country: Spain
facility: ES612
city: Lleida
country: Spain
facility: ES602
city: Madrid
country: Spain
facility: ES613
city: Sant Cugat del Vallès
country: Spain
facility: ES610
city: Sevilla
country: Spain
facility: ES606
city: Terrassa
country: Spain
facility: ES605
city: Valencia
country: Spain
facility: ES607
city: Biel
country: Switzerland
facility: CH603
city: Lausanne
country: Switzerland
facility: CH605
city: Les Acacias
country: Switzerland
facility: CH602
city: Schlieren
country: Switzerland
facility: CH601
city: Balova
country: Turkey
facility: TR602
city: Istanbul
country: Turkey
facility: TR601
city: İstanbul
country: Turkey
facility: TR603
city: Istanbul
country: Turkey
facility: TR605
city: Izmir
country: Turkey
facility: TR606
city: Samsun
country: Turkey
facility: TR607
city: Brentford
country: United Kingdom
facility: GB601
city: Northampton
country: United Kingdom
facility: GB603
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: Ballard C, Atri A, Boneva N, Cummings JL, Frolich L, Molinuevo JL, Tariot PN, Raket LL. Enrichment factors for clinical trials in mild-to-moderate Alzheimer's disease. Alzheimers Dement (N Y). 2019 May 20;5:164-174. doi: 10.1016/j.trci.2019.04.001. eCollection 2019.
citation: Cummings JL, Atri A, Ballard C, Boneva N, Frolich L, Molinuevo JL, Raket LL, Tariot PN. Insights into globalization: comparison of patient characteristics and disease progression among geographic regions in a multinational Alzheimer's disease clinical program. Alzheimers Res Ther. 2018 Nov 24;10(1):116. doi: 10.1186/s13195-018-0443-2.
citation: Atri A, Frolich L, Ballard C, Tariot PN, Molinuevo JL, Boneva N, Windfeld K, Raket LL, Cummings JL. Effect of Idalopirdine as Adjunct to Cholinesterase Inhibitors on Change in Cognition in Patients With Alzheimer Disease: Three Randomized Clinical Trials. JAMA. 2018 Jan 9;319(2):130-142. doi: 10.1001/jama.2017.20373.