Vascular Cognitive ImpairmentPhase 4NCT05050604
A Clinical Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate in Vascular Cognitive Impairment Patients
A Phase 4 study testing Choline Alfoscerate 400mg in people with Vascular Cognitive Impairment, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
This is a multi-center, randomized, double-blind, placebo-controlled, Phase IV Trial to evaluate the efficacy and safety of Choline Alfoscerate compared to placebo in Mild Cognitive Impairment Patients with Cerebrovascular Disease Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Vascular Cognitive Impairment
- What is being tested?
- Choline Alfoscerate 400mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 418 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2021to Nov 2024
- 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
- Age ≥ 50 years
- Patients with vascular cognitive impairment according to modified Fazekas scale grade 2~3 and/or more than 3 of lacunar infarction in Supratentorial
- Patients with Clinical Deterioration Rating(CDR) score of 0.5
- Patients with Korean-Montreal Cognitive Assessment (K-MoCA) score of 23 or less
- Walk or move using walking aids (i.e., walkers, walking sticks or wheelchairs)
- Written informed consent
Who cannot join
- Clinical diagnosis of dementia (including secondary dementia due to Alzheimer's disease, vascular dementia, infections of the central nervous system (e.g., HIV, syphilis), Creutzfeld-Jacob disease, Pixie disease, Huntington's disease, Parkinson's disease, etc.)
- Medication of dementia within the past 3 months. (e.g., donepezil, galantamine, rivastigmine, memantine)
- Medication of brain functional improvement medication within the past 6 weeks. (e.g., citicoline, oxiracetam, piracetam, choline alfoscerate, Nicergoline, Nimodipine, ginko-biloba, acetyl-l carnitine)
- No studies (no regular school entrance), illiteracy
- Stroke within the past 3 months
- Abnormal results from Vitamin B12, Thyroid Stimulated Hormone Test (TSH), HIV-Ab, and VDRL test contribute to or contribute to cognitive impairment of the subject
- Serious mental disorders such as severe depression, schizophrenia, alcoholism, drug dependence, etc.
- Severe cardiovascular disease such as myocardial infarction, unstable angina or heart failure within the past 6 months
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Asan Medical Center
Seoul, 05505
Sun U Kwon, +82230103440, sukwon@amc.seooul.kr
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase IV Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate Compared to Placebo in Mild Cognitive Impairment Patients With Cerebrovascular Disease
This is a multi-center, randomized, double-blind, placebo-controlled, Phase IV Trial to evaluate the efficacy and safety of Choline Alfoscerate compared to placebo in Mild Cognitive Impairment Patients with Cerebrovascular Disease
Read the detailed description
Subject will be randomised in a 1:1 ratio to receive either Choline Alfoscerate or it's placebo. Investigational Product(IP, Choline Alfoscerate or it's placebo) will be administered 3 times a day per oral during the treatment
- Conditions
- Vascular Cognitive Impairment
- Being tested
- Choline Alfoscerate 400mg, Placebo of Choline Alfoscerate 400mg
- Keywords
- Vascular Cognitive Impairment, Choline Alfoscerate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Choline Alfoscerate 400mgDrug
Choline Alfoscerate 400mg per oral 3 times a day during the entrie treatment period
Placebo of Choline Alfoscerate 400mgDrug
Placebo of Choline Alfoscerate 400mg per oral 3 times a day during the entrie treatment period
| Study group | Role | What they receive |
|---|---|---|
| Choline Alfoscerate | Experimental | Not described Receives: Drug: Choline Alfoscerate 400mg |
| Placebo of Choline Alfoscerate | Placebo comparator | Not described Receives: Drug: Placebo of Choline Alfoscerate 400mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects whose cognitive function is maintained/improved at 48 weeks compared to baseline
Measured: Baseline to 48 weeks
Secondary outcomes (8)
The proportion of subjects reduced by more than or eual 0 points for modified ADAS-Cog score at 24 weeks compared to baseline
ADAS-Cog: Alzheimer's Disease Assessment Scale-Cognitive Subscale
Measured: Baseline to 24 weeks
The proportion of subjects reduced by more than 2 points of modified ADAS-Cog score at 24 to 48 weeks compared to baseline
Measured: Baseline, 24 weeks, 48 weeks
The proportion of subjects reduced by more than 4 points of modified ADAS-Cog score at 24 to 48 compared to baseline
Measured: Baseline, 24 weeks, 48 weeks
The change of Modified ADAS-Cog score at 24 to 48 weeks compared to baseline
Measured: Baseline, 24 weeks, 48 weeks
The proportion of subjects increased by more than 0 point of K-MMSE-2 score at 24 and 48 weeks compared to baseline
K-MMSE-2: Korean version Mini-Mental State Exam-2
Measured: Baseline, 24 weeks, 48 weeks
The change of K-MMSE-2 score at 24 to 48 weeks compared to baseline
Measured: Baseline, 24 weeks, 48 weeks
The change of Modified K-MoCA score at 24 to 48 weeks compared to baseline
K-MoCA: Korean-Montreal Cognitive Assessment
Measured: Baseline, 24 weeks, 48 weeks
The change of CDR-SB score at 48 weeks compared to baseline
CDR-SB: Sum of Boxes of Clinical Dementia Rating
Measured: Baseline to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study startSep 2021 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe 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
- 418 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Choline Alfoscerate Re-evaluation Consortium (57 pharmaceutical companies)
- Responsible party
- Sponsor
- Investigators
- Sun U Kwon, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050604
- Sponsor's protocol ID
- INFINITE-V (B78_03VCI2004)
- Status last verified
- Sep 2021
- First submitted
- 10 Sep 2021
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase IV Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate Compared to Placebo in Mild Cognitive Impairment Patients With Cerebrovascular Disease
- ClinicalTrials.gov ID
- NCT05050604
- Acronym / sponsor ID
- INFINITE-V (B78_03VCI2004)
- Conditions
- Vascular Cognitive Impairment
- Keywords
- Vascular Cognitive Impairment, Choline Alfoscerate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 418 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Collaborators
- Choline Alfoscerate Re-evaluation Consortium (57 pharmaceutical companies)
- Study start
- Sep 2021 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 20 Sep 2021 (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.
This is a multi-center, randomized, double-blind, placebo-controlled, Phase IV Trial to evaluate the efficacy and safety of Choline Alfoscerate compared to placebo in Mild Cognitive Impairment Patients with Cerebrovascular Disease
Detailed description
Subject will be randomised in a 1:1 ratio to receive either Choline Alfoscerate or it's placebo. Investigational Product(IP, Choline Alfoscerate or it's placebo) will be administered 3 times a day per oral during the treatment
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 |
|---|---|---|
| Choline Alfoscerate | Experimental | Drug: Choline Alfoscerate 400mg |
| Placebo of Choline Alfoscerate | Placebo comparator | Drug: Placebo of Choline Alfoscerate 400mg |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 50 years
- Patients with vascular cognitive impairment according to modified Fazekas scale grade 2~3 and/or more than 3 of lacunar infarction in Supratentorial
- Patients with Clinical Deterioration Rating(CDR) score of 0.5
- Patients with Korean-Montreal Cognitive Assessment (K-MoCA) score of 23 or less
- Walk or move using walking aids (i.e., walkers, walking sticks or wheelchairs)
Key exclusion criteria (8 listed)
- Clinical diagnosis of dementia (including secondary dementia due to Alzheimer's disease, vascular dementia, infections of the central nervous system (e.g., HIV, syphilis), Creutzfeld-Jacob disease, Pixie disease, Huntington's disease, Parkinson's disease, etc.)
- Medication of dementia within the past 3 months. (e.g., donepezil, galantamine, rivastigmine, memantine)
- Medication of brain functional improvement medication within the past 6 weeks. (e.g., citicoline, oxiracetam, piracetam, choline alfoscerate, Nicergoline, Nimodipine, ginko-biloba, acetyl-l carnitine)
- No studies (no regular school entrance), illiteracy
- Stroke within the past 3 months
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 |
|---|---|---|
| Choline Alfoscerate 400mgCholine Alfoscerate 400mg per oral 3 times a day during the entrie treatment period | Drug | Choline Alfoscerate |
| Placebo of Choline Alfoscerate 400mgPlacebo of Choline Alfoscerate 400mg per oral 3 times a day during the entrie treatment period | Drug | Placebo of Choline Alfoscerate |
Primary outcome
The proportion of subjects whose cognitive function is maintained/improved at 48 weeks compared to baseline
Time frame: Baseline to 48 weeks
8 secondary outcomes
The proportion of subjects reduced by more than or eual 0 points for modified ADAS-Cog score at 24 weeks compared to baseline
Time frame: Baseline to 24 weeks
The proportion of subjects reduced by more than 2 points of modified ADAS-Cog score at 24 to 48 weeks compared to baseline
Time frame: Baseline, 24 weeks, 48 weeks
The proportion of subjects reduced by more than 4 points of modified ADAS-Cog score at 24 to 48 compared to baseline
Time frame: Baseline, 24 weeks, 48 weeks
The change of Modified ADAS-Cog score at 24 to 48 weeks compared to baseline
Time frame: Baseline, 24 weeks, 48 weeks
The proportion of subjects increased by more than 0 point of K-MMSE-2 score at 24 and 48 weeks compared to baseline
Time frame: Baseline, 24 weeks, 48 weeks
The change of K-MMSE-2 score at 24 to 48 weeks compared to baseline
Time frame: Baseline, 24 weeks, 48 weeks
The change of Modified K-MoCA score at 24 to 48 weeks compared to baseline
Time frame: Baseline, 24 weeks, 48 weeks
The change of CDR-SB score at 48 weeks compared to baseline
Time frame: Baseline to 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 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.
Sun U Kwon, MD, PhD principal investigator
Asan 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 Choline Alfoscerate 400mg in people with Vascular Cognitive Impairment, run by Chong Kun Dang Pharmaceutical 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 8 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 20 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sun U Kwon, MD, PhD (+82230103440, sukwon@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects whose cognitive function is maintained/improved at 48 weeks compared to baseline (time frame: Baseline to 48 weeks). 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 20 Sep 2021.