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

This study has been terminated.

(Lack of patients to enroll.)

Sponsor:

Information provided by:

Eisai Inc.

ClinicalTrials.gov Identifier:

NCT00165750

First received: September 12, 2005

Last updated: January 8, 2009

Last verified: January 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

January 8, 2009

Start Date ^ICMJE

March 2005

Estimated Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

MRI, ADAS-cog [ Time Frame: 0, 12, 24 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00165750 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

ADL, BPSD, CDR-SB, ZBI, GHQ, CIBIC plus [ Time Frame: 0, 12, 24 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Alzheimer's Disease

Intervention ^ICMJE

Drug: DONEPEZIL HYDROCHLORIDE

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

Other Name: Aricept

Study Arm (s)

Experimental: 1

Intervention: Drug: DONEPEZIL HYDROCHLORIDE

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

November 2008

Estimated Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria:

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

Exclusion criteria:

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

Gender

Both

Ages

60 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT00165750

Other Study ID Numbers ^ICMJE

AS-019 (EKI-5-003)

Has Data Monitoring Committee

Not Provided

Responsible Party

J.S. Yoon, Principal Investigator, Cheonnam University Hospital

Study Sponsor ^ICMJE

Eisai Korea Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Jihee Mun

Eisai Korea Inc.

Information Provided By

Eisai Inc.

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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