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

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ClinicalTrials.gov Identifier: NCT02955706
Recruitment Status : Unknown
Verified November 2016 by Dong-A ST Co., Ltd..
Recruitment status was:  Recruiting
First Posted : November 4, 2016
Last Update Posted : November 8, 2016
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.

Brief Summary:
clinical trial to assess the efficacy of Acetyl-L-carnitine

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: Acetyl-L-Carnitine Drug: Placebo of Acetyl-L-Carnitine Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 328 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy of Acetyl-L-carnitine in Patient With Alzheimer's Disease
Study Start Date : April 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : February 2019


Arm Intervention/treatment
Experimental: Active
Acetyl-L-carnitine (DongA ST)
Drug: Acetyl-L-Carnitine
TID
Other Name: Nicetile

Placebo Comparator: placebo
Placebo of Acetyl-L-carnitine (DongA ST)
Drug: Placebo of Acetyl-L-Carnitine
TID
Other Name: Placebo of Nicetile




Primary Outcome Measures :
  1. ADAS-cog [ Time Frame: 24week ]

Secondary Outcome Measures :
  1. K-MMSE [ Time Frame: 12week, 24week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02955706


Contacts
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Contact: YoonHeok Choi 02-920-8864 moon23@donga.co.kr

Locations
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Korea, Republic of
Konkuk university medical center Recruiting
Seoul, Korea, Republic of, KS013
Contact: SeolHee Han, MD         
Sponsors and Collaborators
Dong-A ST Co., Ltd.
Investigators
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Principal Investigator: Seol Hee Han, MD Konkuk University Medical Center

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Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT02955706     History of Changes
Other Study ID Numbers: NCT_ADC_IV
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Acetylcarnitine
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Nootropic Agents