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Sponsors and Collaborators: |
Pfizer Eisai Inc. |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00477659 |
The objective of this study is to identify neural correlates of cognitive improvement after three months of donepezil HCl in subjects with mild Alzheimer's Disease (AD), measuring the Functional Hippocampus Connectivity Index (HCI) and Cerebral Blood Flow (CBF) Perfusion in the Medial Temporal Lobe network. The hypothesis is that donepezil HCl will improve MTL connectivity and CBF Perfusion in the MTL-projected target regions, which will significantly correlate with cognitive improvement in mild AD subjects.
Condition | Intervention | Phase |
---|---|---|
Alzheimer's Disease |
Drug: donepezil HCl (Aricept) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Single Center Study To Examine Neural Correlates Of Cognition In Subjects With Mild Alzheimer's Disease After Three Months Of Open Label Donepezil HCl (Aricept® ) Treatment |
Enrollment: | 14 |
Study Start Date: | July 2007 |
Study Completion Date: | August 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Donepezil: Experimental |
Drug: donepezil HCl (Aricept)
Oral donepezil 5mg/day for 4 weeks, followed by 10 mg/day for 8 weeks
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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:
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trials Disclosure Group ) |
Study ID Numbers: | A2501055, E2020-A001-416 |
Study First Received: | May 23, 2007 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00477659 |
Health Authority: | United States: Food and Drug Administration |
fMRI study; open-label donepezil |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Donepezil Alzheimer Disease Central Nervous System Diseases |
Neurodegenerative Diseases Brain Diseases Dementia Cognition Disorders Delirium |
Nootropic Agents Cholinesterase Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Nervous System Diseases Enzyme Inhibitors Cholinergic Agents Tauopathies Central Nervous System Agents Pharmacologic Actions |