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

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.

Completed

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Key information

Conditions

Dementia With Lewy Bodies (DLB) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dementia Lewy Body Disease Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Donepezil

Drug

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

Primary outcomes

FDG-PET

Time frame: 14 weeks

Secondary outcomes

Cognitive function, psychiatric symptoms, global clinical function, and burden of caregiver

Time frame: 14 weeks

Sponsors and collaborators

Lead sponsor

Osaka University

Other

Registry information

Important dates

Study start: 2008
Primary completion: 2015
Study completion: 2015
First posted: Oct 21, 2008
Registry last updated: Oct 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed