Mild Cognitive Impairment
Conditions
Keywords
Mild Cognitive Impairment, Choline Alfoscerate
Brief 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.
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.
Interventions
Choline Alfoscerate 400mg per oral 3 times a day during the entire treatment period.
DRUGPlacebo
Placebo of Choline Alfoscerate 400mg per oral 3 times a day during the entire treatment period.
Sponsors
Choline Alfoscerate Re-evaluation Consortium (57 pharmaceutical companies)
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 55 years 2. Diagnosis of mild cognitive impairment due to Alzheimer's disease that meets NIA-AA criteria 3. Diagnosed with mild cognitive impairment on SNSB 4. Delayed recall score of SVLT ≤ average -1.5 standard deviation 5. K-MMSE-2 score ≥ 24 6. The CDR score 0.5, and the memory item score 0.5 or 1 point 7. Patients with caregivers who are in regular contact, can visit together 8. Walk or move using walking aids (i.e., walkers, walking sticks or wheelchairs) 9. Sufficient vision, hearing, language skills, motor skills, and understanding to follow the examination procedure. 10. Written informed consent
Exclusion criteria
1. 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.) 2. Medication of dementia within the past three months 3. Brain functional improvement medication in the past six weeks. 4. Medication that may affect cognitive function during clinical trials 5. No studies (no regular school entrance), illiteracy 6. 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) 7. 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 8. Serious mental disorders such as severe depression, schizophrenia, alcoholism, drug dependence, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of subjects whose cognitive function is maintained/improved at 48 weeks compared to baseline | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of subjects reduced by more than 2 points of modified ADAS-Cog score at 24 to 48 weeks compared to baseline | 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 | Baseline, 24 weeks, 48 weeks | — |
| The change of Modified ADAS-Cog score at 24 to 48 weeks compared to baseline | Baseline, 24 weeks, 48 weeks | The Modified ADAS-Cog 13 scale has a total of 85 points, and the higher the score, the higher the severity. |
| The proportion of subjects reduced by more than or equal to 0 points for modified ADAS-Cog score at 24 weeks compared to baseline | Baseline to 24 weeks | — |
| The change of K-MMSE-2 score at 24 to 48 weeks compared to baseline | Baseline, 24 weeks, 48 weeks | K-MMSE-2 scale has a total of 30 points, and the lower the score, the higher the severity. |
| The change of CDR-SB score at 48 weeks compared to baseline | Baseline to 48 weeks | 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. |
| 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 | Baseline, 24 weeks, 48 weeks | — |
Countries
South Korea
Contacts
Primary ContactJaeHong Lee, MD
Outcome results
None listed