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Correlation Between Regional Brain Volume and Response to Donepezil Treatment in AD Patients

NCT ID: NCT00165750

Last Updated: 2013-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2008-11-30

Brief Summary

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This study investigate the relationship between regional brain volume measured by MRI and donepezil treatment response in patients with Alzheimer's Disease.

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

DONEPEZIL HYDROCHLORIDE

Intervention Type DRUG

One 5mg table, once daily. (After 4 weeks treatment, the dose can be increased 10mg once daily.)

Interventions

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DONEPEZIL HYDROCHLORIDE

One 5mg table, once daily. (After 4 weeks treatment, the dose can be increased 10mg once daily.)

Intervention Type DRUG

Other Intervention Names

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Aricept

Eligibility Criteria

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Inclusion Criteria

1. Over 60 years old.
2. Probable or possible Alzheimer's Disease according to the DSM-IV and NINCDS-ADRDA.
3. MMSE score of 10\~24, CDR of 1\~2.
4. Patients didn't take acetylcholinesterase inhibitors 4 weeks before screening.
5. Permitted drugs: antipsychiatric drug for BPSD, antidepression drug, tranquilizer, treatment drug for physical disease for example hypertension.

Exclusion Criteria

1. Uncontrolled by donepezil because of adverse events.
2. No longer continuing treatment of donepezil for refuse, drug-drug interaction etc.
3. If they have taken concomitant medication which were not allowed.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Korea Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jihee Mun

Role: STUDY_DIRECTOR

Eisai Korea Inc.

Locations

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Cheonnam University Hospital

Gwangju, Gwangju, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AS-019 (EKI-5-003)

Identifier Type: -

Identifier Source: org_study_id