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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00555204 |
The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for Alzheimer's disease.
Condition | Intervention | Phase |
---|---|---|
Alzheimer's Disease |
Drug: ABT-089 Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 400 |
Study Start Date: | November 2007 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental |
Drug: ABT-089
5 mg - capsules once daily for 12 weeks
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B: Experimental |
Drug: ABT-089
10 mg - capsules once daily for 12 weeks
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C: Experimental |
Drug: ABT-089
15 mg - capsules once daily for 12 weeks
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D: Experimental |
Drug: ABT-089
20 mg - capsules once daily for 12 weeks
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E: Experimental |
Drug: ABT-089
30 mg - capsules once daily for 12 weeks
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F: Experimental |
Drug: ABT-089
35 mg - capsules once daily for 12 weeks
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G: Placebo Comparator |
Drug: placebo
placebo - capsules once daily for 12 weeks
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Ages Eligible for Study: | 55 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Betty Prine | 847-937-6928 | betty.prine@abbott.com |
Study Director: | Daniel Llano, MD, PhD | Abbott |
Responsible Party: | Abbott ( Daniel Llano, MD, PhD, Medical Director ) |
Study ID Numbers: | M06-876 |
Study First Received: | November 7, 2007 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00555204 |
Health Authority: | United States: Food and Drug Administration |
mild to moderate Alzheimer's disease, memory, cognition, dementia |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases Neurodegenerative Diseases |
Brain Diseases Dementia Cognition Disorders Delirium |
Nervous System Diseases Tauopathies |