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

Dementia With Lewy Bodies (DLB) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00776347
• Other study ID #: OSK-08096
• Status: Completed
• Phase: N/A
• First received: October 20, 2008
• Last updated: October 14, 2015
• Start date: October 2008
• Est. completion date: February 2015

Study information

• Verified date: October 2015
• Source: Osaka University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 85 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Dementia
• Dementia With Lewy Bodies (DLB)
• Lewy Body Disease

Intervention

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

Locations

Country	Name	City	State
Japan	Osaka University Hospital	Suita,	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Osaka University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FDG-PET		14 weeks	No
Secondary	Cognitive function, psychiatric symptoms, global clinical function, and burden of caregiver		14 weeks	No

External Links

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