Alzheimer DiseasePhase 4NCT02955706
Assessment the Efficacy of Acetyl-L-carnitine in Patient With Alzheimer's Disease
A Phase 4 study testing Acetyl-L-Carnitine in people with Alzheimer Disease, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
clinical trial to assess the efficacy of Acetyl-L-carnitine Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Acetyl-L-Carnitine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 265 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2016to 25 Jan 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
clinical trial to assess the efficacy of Acetyl-L-carnitine
Read the 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
- Conditions
- Alzheimer Disease
- Being tested
- Acetyl-L-Carnitine, Placebo of Acetyl-L-Carnitine
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetyl-L-CarnitineDrug
Also called Nicetile
TID
Placebo of Acetyl-L-CarnitineDrug
Also called Placebo of Nicetile
TID
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Acetyl-L-carnitine (DongA ST) Receives: Drug: Acetyl-L-Carnitine |
| placebo | Placebo comparator | Placebo of Acetyl-L-carnitine (DongA ST) Receives: Drug: Placebo of Acetyl-L-Carnitine |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADAS-cog
Measured: 24week
Secondary outcomes (1)
K-MMSE
Measured: 12week, 24week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study start1 Apr 2016
- Primary completion29 Sep 2018
- Study completion25 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seol Hee Han, MD, Principal investigator, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02955706
- Sponsor's protocol ID
- NCT_ADC_IV
- Status last verified
- Apr 2021
- First submitted
- 2 Nov 2016
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02955706
- Acronym / sponsor ID
- NCT_ADC_IV
- Conditions
- Alzheimer Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 29 Sep 2018 (actual)
- Study completion
- 25 Jan 2019 (actual)
- First posted
- 4 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: Acetyl-L-CarnitineAcetyl-L-carnitine (DongA ST) |
| placebo | Placebo comparator | Drug: Placebo of Acetyl-L-CarnitinePlacebo of Acetyl-L-carnitine (DongA ST) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetyl-L-CarnitineAlso: NicetileTID | Drug | Active |
| Placebo of Acetyl-L-CarnitineAlso: Placebo of NicetileTID | Drug | placebo |
Primary outcome
ADAS-cog
Time frame: 24week
1 secondary outcome
K-MMSE
Time frame: 12week, 24week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seol Hee Han, MD principal investigator
Konkuk University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetyl-L-Carnitine in people with Alzheimer Disease, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADAS-cog (time frame: 24week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.