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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2015-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Dementia With Lewy Bodies (DLB)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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donepezil

Group Type EXPERIMENTAL

Donepezil

Intervention Type DRUG

Dosage: 3mg PO/day for the first 2 weeks and 5mg PO/day for the next 14 weeks Duration: 16 weeks

Donepezil

Intervention Type DRUG

Interventions

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Donepezil

Dosage: 3mg PO/day for the first 2 weeks and 5mg PO/day for the next 14 weeks Duration: 16 weeks

Intervention Type DRUG

Donepezil

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes