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

Chong Kun Dang

Status and phase: Not yet enrolling; Phase 4

Conditions: Mild Cognitive Impairment

Treatments: Drug: Choline Alfoscerate; Drug: Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05041790

B78_02MCI2003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 418 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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418 participants in 2 patient groups, including a placebo group

Choline Alfoscerate

Experimental group

Treatment:

Drug: Choline Alfoscerate

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo