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

April 13, 2021 updated by: Dong-A ST Co., Ltd.

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 to assess the efficacy of Acetyl-L-carnitine

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

265

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active
Acetyl-L-carnitine (DongA ST)
Drug: Acetyl-L-Carnitine
TID
Other Names:
  • Nicetile
Placebo Comparator: placebo
Placebo of Acetyl-L-carnitine (DongA ST)
Drug: Placebo of Acetyl-L-Carnitine
TID
Other Names:
  • Placebo of Nicetile

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ADAS-cog
Time Frame: 24week
24week

Secondary Outcome Measures

Outcome Measure
Time Frame
K-MMSE
Time Frame: 12week, 24week
12week, 24week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A ST Co., Ltd.

Investigators

  • Principal Investigator: Seol Hee Han, MD, Konkuk University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

September 29, 2018

Study Completion (Actual)

January 25, 2019

Study Registration Dates

First Submitted

November 2, 2016

First Submitted That Met QC Criteria

November 2, 2016

First Posted (Estimate)

November 4, 2016

Study Record Updates

Last Update Posted (Actual)

April 14, 2021

Last Update Submitted That Met QC Criteria

April 13, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT_ADC_IV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alzheimer Disease

Clinical Trials on Acetyl-L-Carnitine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe