Safety and Efficacy Study of ABT-089 in Adults With Mild to Moderate Alzheimer's Disease

Study Overview
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Brief Summary
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The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for Alzheimer's disease.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Study Using a Bayesian Adaptive Design to Evaluate the Efficacy and Safety of ABT-089 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: ABT-089
* Drug: ABT-089
* Drug: ABT-089
* Drug: ABT-089
* Drug: ABT-089
* Drug: ABT-089
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has mild to moderate Alzheimer's disease Patient has been receiving a stable dose of an acetylcholinesterase inhibitor Patient has a MMSE score between 12 and 26 Patient has a MHIS score of less than or equal to 4 Females must be postmenopausal for at least two years or surgically sterile Patient has an identified, reliable, caregiver who will support him/her to ensure compliance with treatment and will accompany them to each outpatient visit Exclusion Criteria: Patient is living in a nursing home Patient has a history of any significant neurologic disease other than Alzheimer's disease Patient has any uncontrolled medical illness Patient uses non-prescribed drugs of abuse or has a history of drug or alcohol abuse/dependence

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: ABT-089<br>* 5 mg - capsules once daily for 12 weeks<br>|
| Experimental: B<br> | Drug: ABT-089<br>* 10 mg - capsules once daily for 12 weeks<br>|
| Experimental: C<br> | Drug: ABT-089<br>* 15 mg - capsules once daily for 12 weeks<br>|
| Experimental: D<br> | Drug: ABT-089<br>* 20 mg - capsules once daily for 12 weeks<br>|
| Experimental: E<br> | Drug: ABT-089<br>* 30 mg - capsules once daily for 12 weeks<br>|
| Experimental: F<br> | Drug: ABT-089<br>* 35 mg - capsules once daily for 12 weeks<br>|
| Placebo Comparator: G<br> | Drug: placebo<br>* placebo - capsules once daily for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability |  | Baseline to Final Evaluation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (how the body handles the study drug) |  | Baseline to Final Evaluation | 
| Pharmacodynamic (how the study drug affects cognitive functions such as thinking and memory) |  | Baseline to Final Evaluation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mild to moderate Alzheimer's disease, memory, cognition, dementia