A Clinical Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate Compared to Placebo in Patients With Degenerative Mild Cognitive Impairment

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Drug: Choline Alfoscerate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Choline Alfoscerate<br> | Drug: Choline Alfoscerate<br>* Choline Alfoscerate 400mg per oral 3 times a day during the entire treatment period.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo of Choline Alfoscerate 400mg per oral 3 times a day during the entire treatment period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline to 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | The Modified ADAS-Cog 13 scale has a total of 85 points, and the higher the score, the higher the severity. | 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 |  | 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. | 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. | Baseline to 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Choline Alfoscerate, Mild Cognitive Impairment