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
  Purpose

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


Condition Intervention Phase
Alzheimer's Disease
Drug: DONEPEZIL HYDROCHLORIDE
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Correlation Between Regional Brain Volume and Response to Donepezil Treatment in AD Patients

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

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

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

Enrollment: 40
Study Start Date: March 2005
Study Completion Date: November 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: DONEPEZIL HYDROCHLORIDE
One 5mg table, once daily. (After 4 weeks treatment, the dose can be increased 10mg once daily.)
Other Name: Aricept

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165750

Locations
Korea, Republic of
Cheonnam University Hospital
Gwangju, Korea, Republic of
Sponsors and Collaborators
Eisai Korea Inc.
Investigators
Study Director: Jihee Mun Eisai Korea Inc.
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Korea Inc. )
ClinicalTrials.gov Identifier: NCT00165750     History of Changes
Other Study ID Numbers: AS-019 (EKI-5-003)
Study First Received: September 12, 2005
Last Updated: November 19, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014