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
About this trial
This is an interventional treatment trial for Alzheimer Disease
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
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
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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