Neural Correlates In Mild Alzheimer's Disease
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...
Brief Summary
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”
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.
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: August 2008
Intervention(s) in this Clinical Trial
- Drug: donepezil HCl (Aricept)
- Oral donepezil 5mg/day for 4 weeks, followed by 10 mg/day for 8 weeks
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: Donepezil
Outcome Measures for this Clinical Trial
Primary Measures
- Functional magnetic resonance imaging to identify neural correlates of cognitive improvement after 3 months of donepezil HCl in subjects w/ mild AD, using the Functional Hippocampus Connectivity Index (HCI) and Cerebral Blood Flow (CBF) Perfusion
- Time Frame: 12 weeks
Safety Issue?: No
- Time Frame: 12 weeks
Secondary Measures
- Mini Mental State Exam, Alzheimer's Disease Assess,emt Scale-cognitive subscale, Neuropsychiatric Inventory and Instrumental Activities of Daily Living scales at screen and week 12.
- Time Frame: 12 weeks
Safety Issue?: No
- Time Frame: 12 weeks
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Men and women, aged 50 and older with mild Alzheimer's disease (MMSE scores of 20 to 30 are allowed).
- Diagnostic evidence of Alzheimer's disease.
- Previous use of cholinesterase inhibitors (other than Aricept) and memantine allowed.
Exclusion Criteria:
- Prior use of Aricept, pacemakers and insulin dependent diabetes are not allowed.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 50 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Eisai Inc. Industry
Overall Clinical Trial Officials and Contacts
Pfizer CT.gov Call Center Study Director Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00477659
Study ID Number: A2501055
ClinicalTrials.gov Identifier: NCT00477659
Health Authority: United States: Food and Drug Administration
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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00477659
