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

Not Applicable

Completed

• Conditions: Dementia With Lewy Bodies (DLB)
• Interventions: Drug: Donepezil

• Registration Number: NCT00776347
• Lead Sponsor: Osaka University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-20
• Study First Submitted QC: 2008-10-20
• Study First Posted: 2008-10-21
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-14
• Last Update Posted: 2015-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
donepezil	Donepezil	-

Primary Outcome Measures

Name	Time	Method
FDG-PET	14 weeks

Secondary Outcome Measures

Name	Time	Method
Cognitive function, psychiatric symptoms, global clinical function, and burden of caregiver	14 weeks

Trial Locations

Locations (1)

Osaka University Hospital; 🇯🇵 Suita,, Osaka, Japan