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

O

Osaka University

Status

Completed

Conditions

Dementia With Lewy Bodies (DLB)

Treatments

Drug: Donepezil

Study type

Interventional

Funder types

Other

Identifiers

NCT00776347
OSK-08096

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

60 to 85 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

24 participants in 1 patient group

donepezil
Experimental group
Treatment:
Drug: Donepezil
Drug: Donepezil

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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