Mild Cognitive ImpairmentPhase 4NCT04346862
Evaluation the Effect of Acetyl-L-carnitine in Patients With Mild Cognitive Impairment Accompanied With Chronic Cerebrovascular Disease
A Phase 4 study testing Acetyl-L-carnitine hydrochloride 500mg in people with Mild Cognitive Impairment, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy of Acetyl-L-carnitine in patient with Mild Cognitive Impairment associated with chronic cerebrovascular disease. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Acetyl-L-carnitine hydrochloride 500mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 636 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Jan 2016to 30 Jun 2020
- 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 55 and 85 years old
- Patients with chronic cerebrovascular disease, who have modified Fazekas scale grade 2 ~ 3
- Patients wtih a diagnosis of MCI
- MOCA-K of 23 or less
- Patients who provided a signed written informed consent form
Who cannot join
- Patiens who are uneducated or illiterate
- Patiens previously treated with dementia
- Patients who received a nootropic agent or thyroid hormone within 4 weeks of visit 1
- Patients with cognitive impairment due to diseases other than cerebrovascular disease
- Patients with severe depression, schizophrenia, alcoholism, and drug dependence
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Catholic Kwandong University International St. Mary'S Hospital
Incheon
Young-in Kim, PhD
About this study
Official title: Phase IV Study to Evaluate the Effect of Improvement in Cognitive Impairment of Acetyl-L-carnitine in Patients With Mild Cognitive Impairment Accompanied With Chronic Cerebrovascular Disease
The purpose of this study is to evaluate the efficacy of Acetyl-L-carnitine in patient with Mild Cognitive Impairment associated with chronic cerebrovascular disease.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Acetyl-L-carnitine hydrochloride 500mg, Placebo
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetyl-L-carnitine hydrochloride 500mgDrug
The participants will receive treatment of Acetyl-L-carnitine hydrochloride 500mg, orally, 3 times a day for 24weeks
PlaceboDrug
The participants will receive treatment of placebo of Acetyl-L-carnitine hydrochloride 500mg, orally, 3 times a day for 24weeks
| Study group | Role | What they receive |
|---|---|---|
| Acetyl-L-carnitine hydrochloride | Experimental | Not described Receives: Drug: Acetyl-L-carnitine hydrochloride 500mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interference score using K-CWST(Korean-Color Word Stroop Test)
interference score is defined as 'the time required to test stage 2(Color-Word)' minus ''the time required to test stage 1(Word)
Measured: 24 week
Montreal Cognitive Assessment Korean(MOCA-K)
MOCA-K included cognitive domains; attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. MOCA-K scored from 0 to 30. The higher the score, the better.
Measured: 24 week
Secondary outcomes (3)
Korean Trail Making Test Elderly(K-TMT-e)
The K-TMT-e was composed of 2 parts: part A calls for the test-taker to connect randomly distributed numbers (1-25) on a test paper in ascending order (1->2->3...), whereas part B requires the test-taker to alternate numbers and letters (1->A->2->B...).
Measured: 24 week
EQ-5D
EQ-5D included 5 dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Measured: 24 week
Clinical Global Impression -Improvement (CGI-I)
CGI-I scored from 1 (very much improved) to 7 (very much worse).
Measured: 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start26 Jan 2016
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 636 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346862
- Sponsor's protocol ID
- HM-VASCA-401
- Status last verified
- Apr 2020
- First submitted
- 13 Apr 2020
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study to Evaluate the Effect of Improvement in Cognitive Impairment of Acetyl-L-carnitine in Patients With Mild Cognitive Impairment Accompanied With Chronic Cerebrovascular Disease
- ClinicalTrials.gov ID
- NCT04346862
- Acronym / sponsor ID
- HM-VASCA-401
- Conditions
- Mild Cognitive Impairment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 636 participants (estimated)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2016 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 15 Apr 2020 (actual)
- 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.
The purpose of this study is to evaluate the efficacy of Acetyl-L-carnitine in patient with Mild Cognitive Impairment associated with chronic cerebrovascular disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetyl-L-carnitine hydrochloride | Experimental | Drug: Acetyl-L-carnitine hydrochloride 500mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 55 and 85 years old
- Patients with chronic cerebrovascular disease, who have modified Fazekas scale grade 2 ~ 3
- Patients wtih a diagnosis of MCI
- MOCA-K of 23 or less
- Patients who provided a signed written informed consent form
Key exclusion criteria (5 listed)
- Patiens who are uneducated or illiterate
- Patiens previously treated with dementia
- Patients who received a nootropic agent or thyroid hormone within 4 weeks of visit 1
- Patients with cognitive impairment due to diseases other than cerebrovascular disease
- Patients with severe depression, schizophrenia, alcoholism, and drug dependence
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-carnitine hydrochloride 500mgThe participants will receive treatment of Acetyl-L-carnitine hydrochloride 500mg, orally, 3 times a day for 24weeks | Drug | Acetyl-L-carnitine hydrochloride |
| PlaceboThe participants will receive treatment of placebo of Acetyl-L-carnitine hydrochloride 500mg, orally, 3 times a day for 24weeks | Drug | Placebo |
Primary outcome
Interference score using K-CWST(Korean-Color Word Stroop Test)
Time frame: 24 week
interference score is defined as 'the time required to test stage 2(Color-Word)' minus ''the time required to test stage 1(Word)
Montreal Cognitive Assessment Korean(MOCA-K)
Time frame: 24 week
MOCA-K included cognitive domains; attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. MOCA-K scored from 0 to 30. The higher the score, the better.
3 secondary outcomes
Korean Trail Making Test Elderly(K-TMT-e)
Time frame: 24 week
EQ-5D
Time frame: 24 week
Clinical Global Impression -Improvement (CGI-I)
Time frame: 24 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
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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.
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 hydrochloride 500mg in people with Mild Cognitive Impairment, run by Hanmi Pharmaceutical Company Limited 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 Apr 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin-A Jung, Ph.D (82-2-410-9038, jajung@hanmi.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interference score using K-CWST(Korean-Color Word Stroop Test) (time frame: 24 week). The study lists 2 primary outcomes in all. 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 21 Apr 2020.