NCT00555204
Terminated
Phase 2
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
Overview
- Phase
- Phase 2
- Intervention
- ABT-089
- Conditions
- Alzheimer's Disease
- Sponsor
- Abbott
- Enrollment
- 337
- Primary Endpoint
- Safety and Tolerability
- Status
- Terminated
- Last Updated
- 14 years ago
Overview
Brief Summary
The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for Alzheimer's disease.
Investigators
Eligibility Criteria
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
Arms & Interventions
A
Intervention: ABT-089
B
Intervention: ABT-089
C
Intervention: ABT-089
D
Intervention: ABT-089
E
Intervention: ABT-089
F
Intervention: ABT-089
G
Intervention: placebo
Outcomes
Primary Outcomes
Safety and Tolerability
Time Frame: Baseline to Final Evaluation
Secondary Outcomes
- 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)
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