NCT02955706

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P75+ for phase_4 alzheimer-disease

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 4, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2019

Completed
Last Updated

April 14, 2021

Status Verified

April 1, 2021

Enrollment Period

2.5 years

First QC Date

November 2, 2016

Last Update Submit

April 13, 2021

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

  • ADAS-cog

    24week

Secondary Outcomes (1)

  • K-MMSE

    12week, 24week

Study Arms (2)

Active

EXPERIMENTAL

Acetyl-L-carnitine (DongA ST)

Drug: Acetyl-L-Carnitine

placebo

PLACEBO COMPARATOR

Placebo of Acetyl-L-carnitine (DongA ST)

Drug: Placebo of Acetyl-L-Carnitine

Interventions

Acetyl-L-CarnitineDRUG

TID

Also known as: Nicetile
Active
Placebo of Acetyl-L-CarnitineDRUG

TID

Also known as: Placebo of Nicetile
placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • More than 50 Years
  • probable Alzheimer disease according to DSM-IV and NINCDS-ADRDA standard
  • ≤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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konkuk university medical center

Seoul, KS013, South Korea

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Acetylcarnitine

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CarnitineTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic Chemicals

Study Officials

  • Seol Hee Han, MD

    Konkuk University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2016

First Posted

November 4, 2016

Study Start

April 1, 2016

Primary Completion

September 29, 2018

Study Completion

January 25, 2019

Last Updated

April 14, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)