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

A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy of Acetyl-L-carnitine in Patient With Alzheimer's Disease

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02955706

Enrollment

265

Registered

2016-11-04

Start date

2016-04-01

Completion date

2019-01-25

Last updated

2021-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

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

Interventions

DRUGAcetyl-L-Carnitine

TID

DRUGPlacebo of Acetyl-L-Carnitine

TID

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
ADAS-cog	24week

Secondary

Measure	Time frame
K-MMSE	12week, 24week

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026