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

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

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