Donepezil Therapy and Changes of Symptoms and Glucose Metabolism in Patients With Dementia With Lewy Bodies (DLB)

October 14, 2015 updated by: Hiroaki Kazui, Osaka University
The purpose of this study is to evaluate change of cerebral glucose metabolism by donepezil therapy and to associate change of glucose metabolism and symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Osaka
      • Suita,, Osaka, Japan, 565-0871
        • Osaka University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

DLB patients:

  • who fulfill the diagnostic criteria of DLB
  • 60 to 85 years old
  • right-handed
  • Clinical Dementia Rating (CDR) ≧ 0.5
  • Mini Mental State Examination (MMSE) score from 10 to 26

Normal Controls:

  • who are independent
  • who have no subjective or objective cognitive impairment
  • 60 to 85 years old
  • right-handed
  • MMSE score over 24

Exclusion Criteria:

DLB patients:

  • who have diabetes mellitus
  • who have pathological change on MRI other than brain atrophy
  • who have complication or history of dementia other than DLB, psychiatric disease, and physical disorder that affect brain function
  • who have severe complication of cardiovascular, hepatic, renal, or other diseases unable to secure the safety
  • who have severe digestive ulcus
  • who have severe bronchitic asthma or obstructive lung disease
  • who have no caregiver who knows patient's condition well

Normal Controls:

  • who have diabetes mellitus
  • who have taken donepezil before
  • who have abnormal findings on MRI
  • who have complication or history of brain injury, psychiatric disease, and physical disorder that affect brain function

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: donepezil
Drug: Donepezil
Drug: Donepezil
Dosage: 3mg PO/day for the first 2 weeks and 5mg PO/day for the next 14 weeks Duration: 16 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
FDG-PET
Time Frame: 14 weeks
14 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Cognitive function, psychiatric symptoms, global clinical function, and burden of caregiver
Time Frame: 14 weeks
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Osaka University

Investigators

  • Principal Investigator: Hiroaki Kazui, MD, PhD, Osaka University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

February 1, 2015

Study Registration Dates

First Submitted

October 20, 2008

First Submitted That Met QC Criteria

October 20, 2008

First Posted (ESTIMATE)

October 21, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 15, 2015

Last Update Submitted That Met QC Criteria

October 14, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSK-08096

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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