Efficacy and Safety Study for Subjects With Mild-to-Moderate Alzheimer's Disease

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

Detailed Description
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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

Official Title
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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

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: Placebo
* Drug: ABT-126
* Drug: donepezil


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A. Sugar Pill<br> | Drug: Placebo<br>* Placebo intervention<br>* Other names: Sugar Pill;|
| Experimental: B. ABT-126<br> | Drug: ABT-126<br>* Experimental intervention<br>|
| Experimental: C. ABT-126<br> | Drug: ABT-126<br>* Experimental intervention<br>|
| Active Comparator: D. donepezil<br> | Drug: donepezil<br>* Active comparator intervention<br>* Other names: Aricept;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADAS-Cog - Alzheimer's Disease Assessment Scale Cognition portion |  | Measurements up through 12 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |