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

NCT ID: NCT02955706

Last Updated: 2021-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

265 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2019-01-25

Brief Summary

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

Detailed Description

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A multicenter, randomized, double-blind, placebo-controlled clinical trial to assess the efficacy of Acetyl-L-carnitine in patient with Alzheimer's disease

Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Active

Acetyl-L-carnitine (DongA ST)

Group Type EXPERIMENTAL

Acetyl-L-Carnitine

Intervention Type DRUG

TID

placebo

Placebo of Acetyl-L-carnitine (DongA ST)

Group Type PLACEBO_COMPARATOR

Placebo of Acetyl-L-Carnitine

Intervention Type DRUG

TID

Interventions

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Acetyl-L-Carnitine

TID

Intervention Type DRUG

Placebo of Acetyl-L-Carnitine

TID

Intervention Type DRUG

Other Intervention Names

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Nicetile Placebo of Nicetile

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Seol Hee Han, MD

Role: PRINCIPAL_INVESTIGATOR

Konkuk University Medical Center

Locations

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Konkuk university medical center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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NCT_ADC_IV

Identifier Type: -

Identifier Source: org_study_id

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