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Completed

NCT Number: NCT02955706

Assessment the Efficacy of Acetyl-L-carnitine in Patient With Alzheimer's Disease

clinical trial to assess the efficacy of Acetyl-L-carnitine

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Konkuk university medical center

Seoul, KS013, South Korea

About this study

A multicenter, randomized, double-blind, placebo-controlled clinical trial to assess the efficacy of Acetyl-L-carnitine in patient with Alzheimer's disease

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • More than 50 Years
  • 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

  • possible or probable or definite vascular dementia according to NINDS-AIREN standard
  • 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

Treatment and study plan

Acetyl-L-carnitine

Drug

TID

Other names: Nicetile

Placebo of Acetyl-L-Carnitine

Drug

TID

Other names: Placebo of Nicetile

Primary outcomes

  1. ADAS-cog

    Time frame: 24week

Secondary outcomes

  1. K-MMSE

    Time frame: 12week, 24week

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy of Acetyl-L-carnitine in Patient With Alzheimer's Disease

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Nov 4, 2016
Registry last updated
Apr 14, 2021

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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