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

NCT05041790 | Unknown Phase 4

• 1 other identifier: B78_02MCI2003
• Study Type: interventional
• Target: 418
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment; Choline Alfoscerate

Outcome Measures

Primary Outcomes (1)

• 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 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

  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

  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

Study Arms (2)

Choline Alfoscerate

EXPERIMENTAL

Drug: Choline Alfoscerate

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Choline Alfoscerate DRUG

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

Choline Alfoscerate

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead
• Choline Alfoscerate Re-evaluation Consortium (57 pharmaceutical companies): collaborator

Study Sites (1)

Asan Medical Center Institutional Review Board

Seoul, South Korea

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Glycerylphosphorylcholine

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Glycerophosphates; Triose Sugar Alcohols; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Glycerophospholipids; Phosphatidic Acids; Phospholipids; Membrane Lipids; Lipids; Lecithins; Phosphatidylcholines

Study Officials

• JaeHong Lee, MD

  Asan Medical Center Institutional Review Board

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JaeHong Lee, MD

CONTACT

+82-2-3010-3446; jhlee@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 13, 2021
• Study Start: September 30, 2021
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: September 20, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)