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Neural Correlates In Mild Alzheimer's Disease

NCT ID: NCT00477659

Last Updated: 2021-11-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-23

Study Completion Date

2008-08-15

Brief Summary

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The objective of this study was to identify neural correlates of cognitive improvement after 3 months of donepezil hydrochloride treatment using either or both of two functional magnetic resonance imaging (fMRI) measures - the functional Hippocampus Connectivity Index (HCI) and Cerebral Blood Flow (CBF) Perfusion; in the Medial Temporal Lobe (MTL) network in subjects in the early stage of Alzheimer's Disease (AD).

Detailed Description

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Conditions

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Alzheimer's Disease

Keywords

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Functional magnetic resonance imaging examination Alzheimer's Disease Donepezil hydrochloride Aricept

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Donepezil hydrochloride

Group Type EXPERIMENTAL

Donepezil hydrochloride

Intervention Type DRUG

Donepezil hydrochloride 5 mg per day orally, once daily for 4 weeks, followed by 10 mg per day (two 5-mg tablets) for 8 weeks

Interventions

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Donepezil hydrochloride

Donepezil hydrochloride 5 mg per day orally, once daily for 4 weeks, followed by 10 mg per day (two 5-mg tablets) for 8 weeks

Intervention Type DRUG

Other Intervention Names

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E2020, Aricept

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Eisai Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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A2501055

Identifier Type: OTHER

Identifier Source: secondary_id

E2020-A001-416

Identifier Type: -

Identifier Source: org_study_id