Efficacy and Safety Study of ABT-288 in Subjects With Mild-to-Moderate Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
Efficacy and safety study of ABT-288 in adults with mild-to-moderate Alzheimer's disease.

Official Title
-----------------
A Randomized, Double-Blind, Active- and Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT-288 in Subjects With Mild-to-Moderate Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: ABT-288
* Drug: donepezil
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Have voluntarily signed an informed consent. 2. Subject meets diagnostic criteria criteria for probable AD (Alzheimer's Disease). 3. Female subjects must be postmenopausal for at least 2 years or surgically sterile. 4. Male subjects must be surgically sterile, sexually inactive or using a barrier method of birth control. 5. Subject has an identified, reliable caregiver. 6. Subject has a CT or MRI scan within 36 months prior to randomization. 7. With the exception of a diagnosis of mild-to-moderate AD and the presence of stable medical conditions, the subject is generally in good health based on medical history, physical examination, vital signs, clinical lab tests and ECG Exclusion Criteria: 1. Subject is currently taking or has taken a medication for the treatment of AD or dementia with 60 days of Screening visit, or is participating in cognitive therapy for the treatment of AD or dementia. 2. Subject uses non-prescribed drugs of abuse or has a history of drug or alcohol abuse/dependence. 3. Subject has a history of any significant neurologic disease other than AD. 4. Subject has a history of intolerance or adverse reaction to donepezil that led to discontinuation. 5. Subject has received any investigation product within 6 weeks prior to study drug administration.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1, Dose 1, ABT-288<br>Low Dose | Drug: ABT-288<br>* Subjects will take 4 capsules once daily for 12 weeks.<br>|
| Experimental: Arm 2, Dose 2, ABT-288<br>High dose | Drug: ABT-288<br>* Subjects will take 4 capsules once daily for 12 weeks.<br>|
| Active Comparator: donepezil<br> | Drug: donepezil<br>* Subjects will take 4 capsules once daily for 12 weeks.<br>* Other names: Aricept;|
| Placebo Comparator: sugar pill<br> | Drug: placebo<br>* Subjects will take 4 capsules once daily for 12 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADAS-cog: Alzheimer's Disease Assessment Scale - Cognition portion |  | Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MMSE: Mini Mental Status Exam |  | Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD | 
| NPI: Neuropsychiatric Inventory |  | Day -1, Weeks 4,8, 12/PD | 
| ADCS-ADL: Alzheimer's Disease Cooperative Study |  | Day -1, Weeks 4,8 & 12/PD | 
| CIBIC-Plus: Clinician Interview-Baed Impression of Change - plus |  | Day -1, Weeks 4,8 & 12/PD] |