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

November 19, 2013 updated by: Eisai Korea Inc.
This study investigate the relationship between regional brain volume measured by MRI and donepezil treatment response in patients with Alzheimer's Disease.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

56 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: DONEPEZIL HYDROCHLORIDE
One 5mg table, once daily. (After 4 weeks treatment, the dose can be increased 10mg once daily.)
Other Names:
  • Aricept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MRI, ADAS-cog
Time Frame: 0, 12, 24 weeks
0, 12, 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
ADL, BPSD, CDR-SB, ZBI, GHQ, CIBIC plus
Time Frame: 0, 12, 24 weeks
0, 12, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Korea Inc.

Investigators

  • Study Director: Jihee Mun, Eisai Korea Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

November 20, 2013

Last Update Submitted That Met QC Criteria

November 19, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AS-019 (EKI-5-003)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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