Assessment the Efficacy of Acetyl-L-carnitine in Patient With Alzheimer's Disease
NCT ID: NCT02955706
Last Updated: 2021-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
265 participants
INTERVENTIONAL
2016-04-01
2019-01-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active
Acetyl-L-carnitine (DongA ST)
Acetyl-L-Carnitine
TID
placebo
Placebo of Acetyl-L-carnitine (DongA ST)
Placebo of Acetyl-L-Carnitine
TID
Interventions
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Acetyl-L-Carnitine
TID
Placebo of Acetyl-L-Carnitine
TID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* probable Alzheimer disease according to DSM-IV and NINCDS-ADRDA standard
* 12≤K-MMSE(screening)≤26
* be able to perform examinations
* Patient taking donepezil(5mg or 10mg/day) more than 3 months
* be able to visit to hospital with caregiver
Exclusion Criteria
* CNS disease(Cerebrovascular diseases, Epilepsy etc) to cause dementia
* Illiteracy
* Patient taking galantamine, memantine, rivastigmine within three months
* Patient taking brain enhancer, thyroid hormone within 4 weeks
* Patient taking Central nervous system stimulant, Antipsychotic agent, anticholinergic agent within 2 weeks
* at screenig blood test: AST, ALT≥ 3 X upper limit of normal range or Hb≤8g/dL or platelet\<100,000/mm3 or Serum creatinine ≥ 3 X upper limit of normal range
* Abnormal result of Vit.B12, Syphilis serology, TSH
* Severe Depression, Schizophrenia, Alcoholism, Drug addiction
* Parkinson's disease (need to drug therapy)
* Angina, Myocardial infarction, ischemia within six months
* Head injury with sense of loss within six months
* Patient taking other IP within three months
* Hypersensitivity to IP
* Sever Hearing problems or Visual impairment
50 Years
ALL
No
Sponsors
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Dong-A ST Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Seol Hee Han, MD
Role: PRINCIPAL_INVESTIGATOR
Konkuk University Medical Center
Locations
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Konkuk university medical center
Seoul, , South Korea
Countries
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Other Identifiers
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NCT_ADC_IV
Identifier Type: -
Identifier Source: org_study_id
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