Clinical trial NCT00948909: Efficacy and Safety Study for Subjects With Mild-to-Moderate Alzheimer's Disease
Official title: A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild-to-Moderate Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2009-07-29
Enrollment: 274
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a efficacy and safety study evaluating new treatment for subjects with mild to moderate Alzheimer's Disease.

Detailed description: This is a Phase 2 study designed to evaluate the efficacy and safety of ABT-126 in approximately 260 adults with mild-to-moderate Alzheimer's disease (AD). Subjects will be randomized to one of the four treatment groups (ABT-126, donepezil, or placebo) for a 12-week Treatment Period. Acronyms are listed in the secondary outcome section, below, you will find a list of the acronyms defined:

* MMSE - Mini Mental Status Exam
* QoL-AD - Quality of Life - Alzheimer's Disease
* CIBIC-plus - Clinician Interview-Based Impression of Change
* NPI - Neuropsychiatric Inventory
* CSDD - The Cornell Scale for depression in Dementia
* ADCS-ADL - Alzheimer's Disease Cooperative Study - Activities of Daily Living

Eligibility criteria: Inclusion Criteria:

* The subject is a male or female between the ages of 55 and 90 years, inclusive, at Screening Visit 1.
* The subject meets the NINCDS/ADRDA criteria for probable AD.
* The subject has a Mini-Mental Status Examination (MMSE) total score of 10 to 24, inclusive, at Screening Visit 1.
* The subject has a Modified Hachinski Ischemic Scale (MHIS) score of less than or equal to 4 at Screening Visit 1.
* If female, subject must be postmenopausal for at least two years or surgically sterile
* The subject has an identified, reliable, caregiver.

Exclusion Criteria:

* The subject is currently taking or has taken a medication for the treatment of Alzheimer's disease or dementia within 60 days prior to Screening Visit 1
* The subject has a history of any significant neurologic disease other than AD.
* In the opinion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness.
* The subject has reported history of discontinuation of donepezil due to lack of efficacy.
* The subject has a history of intolerance or adverse reaction to donepezil that led to discontinuation.
* The subject has a known hypersensitivity to donepezil, piperidine derivatives, or any of the excipients in either donepezil hydrochloride or ABT-126 formulations.
* Patient uses non-prescribed drugs of abuse or has a history of drug or alcohol abuse/dependence.
* Subjects with AST and ALT values at Screening Visit 1 that are greater than or equal to 1.5-fold the upper limit of normal (ULN).

Primary outcomes:
measure: ADAS-Cog - Alzheimer's Disease Assessment Scale Cognition portion
timeFrame: Measurements up through 12 weeks.
Secondary outcomes:
measure: MMSE, QoL-AD, CIBIC-plus, NPI, CSDD, ADAS-Cog (13 item) and ADCS-ADL. Note: Acronyms are fully defined in the area titled Detailed Description.
timeFrame: Measurements up through 12 weeks.
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Site Reference ID/Investigator# 19904
state: California
city: West Palm Beach
country: United States
facility: Site Reference ID/Investigator# 23025
state: Florida
city: Indianapolis
country: United States
facility: Site Reference ID/Investigator# 19905
state: Indiana
city: Pleven
country: Bulgaria
facility: Site Reference ID/Investigator# 22944
city: Plovdiv
country: Bulgaria
facility: Site Reference ID/Investigator# 22942
city: Sofia
country: Bulgaria
facility: Site Reference ID/Investigator# 22945
city: Sofia
country: Bulgaria
facility: Site Reference ID/Investigator# 22946
city: Litomerice
country: Czech Republic
facility: Site Reference ID/Investigator# 20276
city: Plzen
country: Czech Republic
facility: Site Reference ID/Investigator# 20273
city: Prague 10
country: Czech Republic
facility: Site Reference ID/Investigator# 20274
city: Prague 2
country: Czech Republic
facility: Site Reference ID/Investigator# 20272
city: Prague 5
country: Czech Republic
facility: Site Reference ID/Investigator# 20701
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 23625
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 23624
city: Michalovce
country: Slovakia
facility: Site Reference ID/Investigator# 23622
city: Rimavska Sobota
country: Slovakia
facility: Site Reference ID/Investigator# 23942
city: Belville
country: South Africa
facility: Site Reference ID/Investigator# 20267
city: Cape Town
country: South Africa
facility: Site Reference ID/Investigator# 20266
city: Durban
country: South Africa
facility: Site Reference ID/Investigator# 20261
city: George
country: South Africa
facility: Site Reference ID/Investigator# 21682
city: Johannesburg
country: South Africa
facility: Site Reference ID/Investigator# 20265
city: Port Elizabeth
country: South Africa
facility: Site Reference ID/Investigator# 20271
city: Richards Bay
country: South Africa
facility: Site Reference ID/Investigator# 20263
city: Blackburn
country: United Kingdom
facility: Site Reference ID/Investigator# 20187
city: Bradford
country: United Kingdom
facility: Site Reference ID/Investigator# 20183
city: Crowborough
country: United Kingdom
facility: Site Reference ID/Investigator# 20191
city: Glasgow
country: United Kingdom
facility: Site Reference ID/Investigator# 20184
city: London
country: United Kingdom
facility: Site Reference ID/Investigator# 20190
city: Southampton
country: United Kingdom
facility: Site Reference ID/Investigator# 20192
Study officials:
affiliation: AbbVie
name: Laura Gault, MD
role: STUDY_DIRECTOR
References:
citation: Gault LM, Ritchie CW, Robieson WZ, Pritchett Y, Othman AA, Lenz RA. A phase 2 randomized, controlled trial of the alpha7 agonist ABT-126 in mild-to-moderate Alzheimer's dementia. Alzheimers Dement (N Y). 2015 Jun 23;1(1):81-90. doi: 10.1016/j.trci.2015.06.001. eCollection 2015 Jun.