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

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Acetyl-L-Carnitine
Placebo of Acetyl-L-Carnitine
Sponsored by
Dong-A ST Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Konkuk university medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

placebo

Arm Description

Acetyl-L-carnitine (DongA ST)

Placebo of Acetyl-L-carnitine (DongA ST)

Outcomes

Primary Outcome Measures

ADAS-cog

Secondary Outcome Measures

K-MMSE

Full Information

First Posted
November 2, 2016
Last Updated
April 13, 2021
Sponsor
Dong-A ST Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02955706
Brief Title
Assessment the Efficacy of Acetyl-L-carnitine in Patient With Alzheimer's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
September 29, 2018 (Actual)
Study Completion Date
January 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A ST Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
265 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
Acetyl-L-carnitine (DongA ST)
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo of Acetyl-L-carnitine (DongA ST)
Intervention Type
Drug
Intervention Name(s)
Acetyl-L-Carnitine
Other Intervention Name(s)
Nicetile
Intervention Description
TID
Intervention Type
Drug
Intervention Name(s)
Placebo of Acetyl-L-Carnitine
Other Intervention Name(s)
Placebo of Nicetile
Intervention Description
TID
Primary Outcome Measure Information:
Title
ADAS-cog
Time Frame
24week
Secondary Outcome Measure Information:
Title
K-MMSE
Time Frame
12week, 24week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seol Hee Han, MD
Organizational Affiliation
Konkuk University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Konkuk university medical center
City
Seoul
ZIP/Postal Code
KS013
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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