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

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ClinicalTrials.gov Identifier: NCT00165750
Recruitment Status : Terminated (Lack of patients to enroll.)
First Posted : September 14, 2005
Last Update Posted : November 20, 2013
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Korea Inc. )

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

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: DONEPEZIL HYDROCHLORIDE Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Correlation Between Regional Brain Volume and Response to Donepezil Treatment in AD Patients
Study Start Date : March 2005
Primary Completion Date : August 2008
Study Completion Date : November 2008

Arm Intervention/treatment
One 5mg table, once daily. (After 4 weeks treatment, the dose can be increased 10mg once daily.)
Other Name: Aricept

Primary Outcome Measures :
  1. MRI, ADAS-cog [ Time Frame: 0, 12, 24 weeks ]

Secondary Outcome Measures :
  1. ADL, BPSD, CDR-SB, ZBI, GHQ, CIBIC plus [ Time Frame: 0, 12, 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00165750

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

Responsible Party: Eisai Korea Inc.
ClinicalTrials.gov Identifier: NCT00165750     History of Changes
Other Study ID Numbers: AS-019 (EKI-5-003)
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: November 20, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents