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NCT Number: NCT00381381

The Clinical Response of Choline Acetyltransferase and Apolipoprotein Epsilon Gene Polymorphisms to Donepezil in Alzheimer's Disease

This study attempts to differentiate the clinical responses of Choline Acetyltransferase and Apolipoprotein Epsilon gene polymorphism to donepezil in Alzheimer's Disease patients.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Bundang Hospital, Bundang, South Korea

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age: 60 - 90 years old.
  • CDR: 0.5 - 2.0.
  • Patients who do not have severe depressive symptoms that affect cognition on depression scale of CERAD-K(C), GDS-K: 19 and below.
  • Modified Hachinski Ischemic Score (Rosen, et. al., 1979): 3 and below.
  • NINCDS-ADRDA criteria: Probable AD.

Exclusion criteria

  • Patients who have delusions and other conscious dysfunction.
  • Patients who have neurologic diseases such as Parkinson's disease, stroke, tumor, normal pressure hydrocephalus, etc., on history and neurologic examination.
  • Patients who have history of infectious and inflammatory brain disease owing to virus, fungus and syphilis.
  • Patients with severe cerebrovascular pathology.
  • Patients who have present history of major psychological diseases such as depression and mania according to DSM-IV criteria.
  • Patients who have history of alcoholism or drug addiction.
  • Patients who have severe depressive symptoms that affect cognition on depression scale of CERAD-K.

Treatment and study plan

Donepezil

Drug

2.5mg once daily for the first 7 days, 5mg once daily for the next 3 weeks, after then the dose can be increased 10mg once daily under the investigator's decision.

Other names: Aricept

Primary outcomes

  1. CERAD-K (the Korean Version of the Consortium to Establish a Registry for Alzheimer's Disease)

    Time frame: 26 weeks

    CERAD-K includes: Verbal Fluency-number of kinds of animal patients listed per minute, ranges from 0, no maximum point fixed.Boston Naming Test is naming objects (0-15). Mini-Mental State Examination in the Korean version of CERAD Assessment Packet (0-30). Word List Memory (0-30). Construction Praxis is from 0-11. Word List Recall and Word List Recognition ranges from 0-10.Construction Recall (0-11).

  2. CERAD-K

    Time frame: 26 weeks

    CERAD-K includes: Trail making test A and B is scored by the time spent to link randomly arranged numbers and alphabets in correct order. Except Trail making test A and B, higher score presents better condition.

Secondary outcomes

  1. Neuropsychiatry Inventory (NPI)

    Time frame: 26 weeks

    NPI score after treatment. NPI includes 12 sections which are Delusions, Hallucinations, Agitation, Depression, Anxiety, Euphoria, Apathy, Disinhibition, Irritability, Aberrant motor behavior, Night-time behaviors and Appetite and eating disorders. The score of each section ranges from 0 to 12, and higher score means higher severity and frequency of the neuropsychiatric disturbances.

  2. GDS-K (Geriatric Depression Scale-Korean) Score After Treatment

    Time frame: 26 weeks

    GDS-K score after treatment. Geriatric Depression Scale is a basic screening measure for depression in older adults. It ranges from 0 to 30, and higher score represents more depressed.

Sponsors and collaborators

Lead sponsor

Eisai Korea Inc.

Industry

Registry information

Official study title

A Multi-center Study for the Clinical Response of Choline Acetyltransferase and Apolipoprotein Epsilon Gene Polymorphisms to Donepezil in Alzheimer's Disease

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 27, 2006
Registry last updated
Jan 4, 2022

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.

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