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 (Responsible Party):
Eisai Inc. ( Eisai Korea Inc. )
ClinicalTrials.gov Identifier:
NCT00165750
First received: September 12, 2005
Last updated: November 19, 2013
Last verified: November 2013

September 12, 2005
November 19, 2013
March 2005
August 2008   (final data collection date for primary outcome measure)
MRI, ADAS-cog [ Time Frame: 0, 12, 24 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00165750 on ClinicalTrials.gov Archive Site
ADL, BPSD, CDR-SB, ZBI, GHQ, CIBIC plus [ Time Frame: 0, 12, 24 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Correlation Between Regional Brain Volume and Response to Donepezil Treatment in AD Patients
Correlation Between Regional Brain Volume and Response to Donepezil Treatment in AD Patients

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

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Alzheimer's Disease
Drug: DONEPEZIL HYDROCHLORIDE
One 5mg table, once daily. (After 4 weeks treatment, the dose can be increased 10mg once daily.)
Other Name: Aricept
Experimental: 1
Intervention: Drug: DONEPEZIL HYDROCHLORIDE
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
November 2008
August 2008   (final data collection date for primary outcome measure)

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.
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00165750
AS-019 (EKI-5-003)
Not Provided
Eisai Inc. ( Eisai Korea Inc. )
Eisai Korea Inc.
Not Provided
Study Director: Jihee Mun Eisai Korea Inc.
Eisai Inc.
November 2013

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