Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease

Study Overview
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Brief Summary
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This is an efficacy and safety study evaluating a 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 410 adults with mild to moderate Alzheimer's disease. Subjects will be randomized to one of 5 treatment groups (ABT-126, donepezil or placebo) for a 24-week treatment period.

Official Title
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A Randomized, Double-Blind, Placebo and Active-Controlled 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: donepezil
* Drug: ABT-126


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject and caregiver must voluntarily sign and date an informed consent. If the subject does not have the capacity to provide informed consent, full informed consent must be obtained from the subject's representative and assent must be obtained from the subject. The subject is a male or female between the ages of 55 and 90 years, inclusive, at Screening Visit 1. The subject meets the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's disease. The subject has a Mini-Mental Status Examination (MMSE) total score of 10 to 24, inclusive, at Screening Visit 1. The subject has a Cornell Scale for Depression in Dementia (CSDD) score ≤ 10 at Screening Visit 1. The subject has a Modified Hachinski Ischemic Scale (MHIS) score of ≤ 4 at Screening Visit 1. With the exception of a diagnosis of mild to moderate AD and the presence of stable medical conditions, the subject is in general good health, based upon the results of medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG). The subject has an identified, reliable caregiver who will provide support and ensure compliance with the study medication and procedures, and provide accurate information about the subject's status during the study. 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, or is participating in cognitive therapy for the treatment of Alzheimer's disease or dementia. The subject has clinically significant abnormal laboratory values at Screening Visit 1 as determined by the investigator. The subject has a history of any significant neurologic disease other than Alzheimer's disease including Parkinson's disease, multi-infarct or vascular dementia, Huntington's disease, normal pressure hydrocephalus, progressive supranuclear palsy, multiple sclerosis, any seizures, mental retardation or a history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities. In the opinion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness. The subject has a known hypersensitivity or intolerance to donepezil that lead to discontinuation or a known reported history of donepezil treatment failure.

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: sugar pill<br> | Drug: placebo<br>* Placebo Comparator<br>|
| Active Comparator: donepezil<br> | Drug: donepezil<br>* Active Comparator<br>|
| Experimental: ABT-126 Low Dose<br>low dose | Drug: ABT-126<br>* low dose, middle dose, high dose<br>|
| Experimental: ABT-126 Middle Dose<br>middle dose | Drug: ABT-126<br>* low dose, middle dose, high dose<br>|
| Experimental: ABT-126 high dose<br>high dose | Drug: ABT-126<br>* low dose, middle dose, high dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alzheimer's Disease Assessment Scale - cognitive subscale |  | Measurements up through 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) | Caregiver-based assessment of activities of daily living | Measurements up through 24 weeks | 
| Mini Mental Status Exam (MMSE) | Questionnaire which provides a quantitative measure of cognition | Measurements up through 24 weeks | 
| DEMentia Quality of Life (DEMQOL) | Health-related quality of life measurement tool | Measurements up through 24 weeks | 
| Clinician Interview-Based Impression of Change - plus (CIBIC-plus) | Measures a global impression of change in severity of dementia | Measurements up through 24 weeks | 
| Neuropsychiatry Inventory (NPI) | Assesses the presence of psychopathology in subjects with Alzheimer's disease and other dementias | Measurements up through 24 weeks | 
| Partner-Patient Questionnaire for Shared Activities (PPQSA) | Measures the extent to which mood and mental state interferes with the patient-partner relationship | Measurements up through 24 weeks | 
| Resource Use in Dementia (RUD-Lite) | Brief measurement tool for resource utilization | Measurements up through 24 weeks | 
| EuroQol-5D Questionnaires | Assesses patient's mobility, self-care, usual activity, pain/discomfort and anxiety/depression | Measurements up through 24 weeks | 
| Wechsler Memory Scale-III (WMS-III) Working Memory Index | Assesses working memory | Measurements up through 24 weeks |