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

Dong-A ST

Status and phase

Completed

Phase 4

Conditions

Alzheimer Disease

Treatments

Drug: Placebo of Acetyl-L-Carnitine

Drug: Acetyl-L-Carnitine

Study type

Interventional

Funder types

Industry

Identifiers

NCT02955706

NCT_ADC_IV

Details and patient eligibility

About

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

Full description

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

Enrollment

265 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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