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Trial record 93 of 332 for:    DONEPEZIL

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00165750
Recruitment Status : Terminated (Lack of patients to enroll.)
First Posted : September 14, 2005
Last Update Posted : November 20, 2013
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Korea Inc. )

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 14, 2005
Last Update Posted Date November 20, 2013
Study Start Date  ICMJE March 2005
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2008)
MRI, ADAS-cog [ Time Frame: 0, 12, 24 weeks ]
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
 (submitted: March 21, 2008)
ADL, BPSD, CDR-SB, ZBI, GHQ, CIBIC plus [ Time Frame: 0, 12, 24 weeks ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 Arms  ICMJE 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
Actual Enrollment  ICMJE
 (submitted: January 7, 2009)
40
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00165750
Other Study ID Numbers  ICMJE AS-019 (EKI-5-003)
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eisai Inc. ( Eisai Korea Inc. )
Study Sponsor  ICMJE Eisai Korea Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jihee Mun Eisai Korea Inc.
PRS Account Eisai Inc.
Verification Date November 2013

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