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

• Status: Completed
• Trial end date: 2019-01-25
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dong-A ST Co., Ltd.
• Treatments: Acetylcarnitine

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