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Sponsors and Collaborators: |
Pfizer Alzheimer's Disease Cooperative Study (ADCS) |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00566397 |
This Phase 2 study is designed to evaluate the efficacy and safety of PF 04494700 in participants with mild to moderate Alzheimer's disease.
Condition | Intervention | Phase |
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Alzheimer's Disease |
Drug: PF-04494700 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double Blind, Placebo Controlled, Randomized, Multicenter Study Evaluating The Efficacy And Safety Of Eighteen Months Of Treatment With PF 04494700 (TTP488) In Participants With Mild To Moderate Alzheimer's Disease |
Estimated Enrollment: | 400 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: PF-04494700
15 mg for 6 days followed by daily dosing of 5mg
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2: Experimental |
Drug: PF-04494700
60 mg for 6 days followed by daily dosing of 20mg
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3: Placebo Comparator |
Drug: Placebo
Placebo
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Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alzheimer's Disease Education and Referral Center (ADEAR) | 1-800-438-4380 | |
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | B0341002 |
Study First Received: | November 29, 2007 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00566397 |
Health Authority: | United States: Food and Drug Administration |
RI, RI Study, Rage Inhibitors |
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 |