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
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Alzheimer's Disease
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Enrollment
- 274
- Locations
- 29
- Primary Endpoint
- ADAS-Cog - Alzheimer's Disease Assessment Scale Cognition portion
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •The subject is a male or female between the ages of 55 and 90 years, inclusive, at Screening Visit
- •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
- •The subject has a Modified Hachinski Ischemic Scale (MHIS) score of less than or equal to 4 at Screening Visit
- •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).
Arms & Interventions
A. Sugar Pill
Intervention: Placebo
B. ABT-126
Intervention: ABT-126
C. ABT-126
Intervention: ABT-126
D. donepezil
Intervention: donepezil
Outcomes
Primary Outcomes
ADAS-Cog - Alzheimer's Disease Assessment Scale Cognition portion
Time Frame: Measurements up through 12 weeks.
Secondary Outcomes
- 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.(Measurements up through 12 weeks.)