Mild Cognitive ImpairmentPhase 4NCT05041790
A Clinical Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate Compared to Placebo in Patients With Degenerative Mild Cognitive Impairment
A Phase 4 study testing Choline Alfoscerate in people with Mild 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 patients with degenerative mild cognitive impairment. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Choline Alfoscerate
- 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
- 30 Sep 2021to 30 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 55 years
- Diagnosis of mild cognitive impairment due to Alzheimer's disease that meets NIA-AA criteria
- Diagnosed with mild cognitive impairment on SNSB
- Delayed recall score of SVLT ≤ "average -1.5 standard deviation"
- K-MMSE-2 score ≥ 24
- The CDR score 0.5, and the memory item score 0.5 or 1 point
Show all 10Show fewer
- Patients with caregivers who are in regular contact, can visit together
- Walk or move using walking aids (i.e., walkers, walking sticks or wheelchairs)
- Sufficient vision, hearing, language skills, motor skills, and understanding to follow the examination procedure.
- Written informed consent
Who cannot join
- 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 three months
- Brain functional improvement medication in the past six weeks.
- Medication that may affect cognitive function during clinical trials
- No studies (no regular school entrance), illiteracy
- Significant neurological conditions (such as stroke, multiple sclerosis, severe head trauma with loss of consciousness, cerebral palsy, cerebral tumor, cerebral infarction, spinal infarction or central nervous system infection) and/or evidence (CT or MRI results performed within the past 12 months or during screening)
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Asan Medical Center Institutional Review Board
Seoul
JaeHong Lee, MD, +82-2-3010-3446, jhlee@amc.seoul.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 Patients With Degenerative Mild Cognitive Impairment(ESCALADE)
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 patients with degenerative mild cognitive impairment.
Read the detailed description
Subjects will be randomised in a 1:1 ratio to receive either Choline Alfoscerate or its placebo. Investigational Products(IP, Choline Alfoscerate or its placebo) will be administered 3 times a day per oral during the treatment period.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Choline Alfoscerate, Placebo
- Keywords
- Mild Cognitive Impairment, Choline Alfoscerate
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Choline AlfoscerateDrug
Choline Alfoscerate 400mg per oral 3 times a day during the entire treatment period.
PlaceboDrug
Placebo of Choline Alfoscerate 400mg per oral 3 times a day during the entire treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Choline Alfoscerate | Experimental | Not described Receives: Drug: Choline Alfoscerate |
| 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.
The proportion of subjects whose cognitive function is maintained/improved at 48 weeks compared to baseline
Definition of maintained/improved of cognitive function: decreased by more than or equal to 0 point of modified ADAS-Cog score
Measured: Baseline to 48 weeks
Secondary outcomes (7)
The proportion of subjects reduced by more than or equal to 0 points for modified ADAS-Cog score at 24 weeks compared to baseline
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 weeks compared to baseline
Measured: Baseline, 24 weeks, 48 weeks
The change of Modified ADAS-Cog score at 24 to 48 weeks compared to baseline
The Modified ADAS-Cog 13 scale has a total of 85 points, and the higher the score, the higher the severity.
Measured: Baseline, 24 weeks, 48 weeks
The proportion of subjects increased by more than or equal to 0 point of K-MMSE-2 score at 24 and 48 weeks compared to baseline
Measured: Baseline, 24 weeks, 48 weeks
The change of K-MMSE-2 score at 24 to 48 weeks compared to baseline
K-MMSE-2 scale has a total of 30 points, and the lower the score, the higher the severity.
Measured: Baseline, 24 weeks, 48 weeks
The change of CDR-SB score at 48 weeks compared to baseline
CDR-SB calculates the CDR score as Sum of Boxes, in which case, the score in the six areas obtained by the evaluation is added as it is, and the range of the total score is 0 to 30, and the higher the score, the more severe the degree of dementia.
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 posted13 Sep 2021
- Study start30 Sep 2021 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2024 (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 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- 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
- JaeHong Lee, MD, Principal investigator, Asan Medical Center Institutional Review Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041790
- Sponsor's protocol ID
- B78_02MCI2003
- Status last verified
- Sep 2021
- First submitted
- 3 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 Patients With Degenerative Mild Cognitive Impairment(ESCALADE)
- ClinicalTrials.gov ID
- NCT05041790
- Acronym / sponsor ID
- B78_02MCI2003
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild 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
- 30 Sep 2021 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 13 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 patients with degenerative mild cognitive impairment.
Detailed description
Subjects will be randomised in a 1:1 ratio to receive either Choline Alfoscerate or its placebo. Investigational Products(IP, Choline Alfoscerate or its placebo) will be administered 3 times a day per oral during the treatment period.
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 |
|---|---|---|
| Choline Alfoscerate | Experimental | Drug: Choline Alfoscerate |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 55 years
- Diagnosis of mild cognitive impairment due to Alzheimer's disease that meets NIA-AA criteria
- Diagnosed with mild cognitive impairment on SNSB
- Delayed recall score of SVLT ≤ "average -1.5 standard deviation"
- K-MMSE-2 score ≥ 24
Key exclusion criteria (8 listed)
- 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 three months
- Brain functional improvement medication in the past six weeks.
- Medication that may affect cognitive function during clinical trials
- No studies (no regular school entrance), illiteracy
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 AlfoscerateCholine Alfoscerate 400mg per oral 3 times a day during the entire treatment period. | Drug | Choline Alfoscerate |
| PlaceboPlacebo of Choline Alfoscerate 400mg per oral 3 times a day during the entire treatment period. | Drug | Placebo |
Primary outcome
The proportion of subjects whose cognitive function is maintained/improved at 48 weeks compared to baseline
Time frame: Baseline to 48 weeks
Definition of maintained/improved of cognitive function: decreased by more than or equal to 0 point of modified ADAS-Cog score
7 secondary outcomes
The proportion of subjects reduced by more than or equal to 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 weeks 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 or equal to 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 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
Related trials for Mild Cognitive Impairment
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
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.
JaeHong Lee, MD principal investigator
Asan Medical Center Institutional Review Board
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 in people with Mild 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 10 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 JaeHong Lee, MD (+82-2-3010-3446, jhlee@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.