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: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

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

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

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

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

Lead Sponsor: Eisai Inc.

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on July 02, 2009

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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