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Neural Correlates In Mild Alzheimer's Disease

Information source: Eisai Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alzheimer's Disease

Intervention: donepezil HCl (Aricept) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Eisai Inc.

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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.

Clinical Details

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 (AriceptŪ ) Treatment

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome: 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.

Eligibility

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Pfizer Investigational Site, Milwaukee, Wisconsin 53226, United States
Additional Information

To obtain contact information for a study center near you, click here.

Starting date: July 2007
Last updated: May 6, 2009

Page last updated: August 20, 2015

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