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

Phase 4

Completed

• Conditions: Alzheimer Disease
• Interventions: Drug: Acetyl-L-Carnitine; Drug: Placebo of Acetyl-L-Carnitine

• Registration Number: NCT02955706
• Lead Sponsor: Dong-A ST Co., Ltd.

Brief Summary

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

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

Study Timeline

• Study Start: 2016-04-01
• Study First Submitted: 2016-11-02
• Study First Submitted QC: 2016-11-02
• Study First Posted: 2016-11-04
• Primary Completion: 2018-09-29
• Study Completion: 2019-01-25
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-13
• Last Update Posted: 2021-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 265

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	Acetyl-L-Carnitine	Acetyl-L-carnitine (DongA ST)
placebo	Placebo of Acetyl-L-Carnitine	Placebo of Acetyl-L-carnitine (DongA ST)

Primary Outcome Measures

Name	Time	Method
ADAS-cog	24week

Secondary Outcome Measures

Name	Time	Method
K-MMSE	12week, 24week

Trial Locations

Locations (1)

Konkuk university medical center; 🇰🇷 Seoul, Korea, Republic of