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

Alzheimer Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02955706
• Other study ID #: NCT_ADC_IV
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2016
• Est. completion date: January 25, 2019

Study information

• Verified date: April 2021
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: January 25, 2019
• Est. primary completion date: September 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• Acetyl-L-Carnitine
TID
• Placebo of Acetyl-L-Carnitine
TID

Locations

Country	Name	City	State
Korea, Republic of	Konkuk university medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADAS-cog		24week
Secondary	K-MMSE		12week, 24week