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

Phase 4

Not yet recruiting

• Conditions: Mild Cognitive Impairment
• Interventions: Drug: Placebo; Drug: Choline Alfoscerate

• Registration Number: NCT05041790
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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.

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-03
• Study First Submitted QC: 2021-09-03
• Study First Posted: 2021-09-13
• Last Update Submitted: 2021-09-14
• Last Update Posted: 2021-09-20
• Study Start: 2021-09-30
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 418

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Choline Alfoscerate	Choline Alfoscerate	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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 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 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 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.

Trial Locations

Locations (1)

Asan Medical Center Institutional Review Board; 🇰🇷 Seoul, Korea, Republic of