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

NCT ID: NCT05041790

Last Updated: 2021-09-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 418 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2024-11-30

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.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Choline Alfoscerate

Group Type: EXPERIMENTAL

Choline Alfoscerate

Intervention Type: DRUG

Choline Alfoscerate 400mg per oral 3 times a day during the entire treatment period.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo of Choline Alfoscerate 400mg per oral 3 times a day during the entire treatment period.

Interventions

Choline Alfoscerate

Choline Alfoscerate 400mg per oral 3 times a day during the entire treatment period.

Intervention Type: DRUG

Placebo

Placebo of Choline Alfoscerate 400mg per oral 3 times a day during the entire treatment period.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Choline Alfoscerate Re-evaluation Consortium (57 pharmaceutical companies)

UNKNOWN

Sponsor Role: collaborator

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

JaeHong Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center Institutional Review Board

Locations

Asan Medical Center Institutional Review Board

Seoul, , South Korea

Countries

South Korea

Central Contacts

JaeHong Lee, MD

Role: CONTACT

jhlee@amc.seoul.kr

+82-2-3010-3446

Facility Contacts

JaeHong Lee, MD

Role: primary

jhlee@amc.seoul.kr

+82-2-3010-3446

Other Identifiers

B78_02MCI2003

Identifier Type: -

Identifier Source: org_study_id