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)

Chong Kun Dang Pharmaceutical1 site in 1 country418 target enrollmentSeptember 30, 2021

ConditionsMild Cognitive Impairment

InterventionsCholine Alfoscerate Placebo

DrugsCholine Alfoscerate Placebo

Overview

Phase: Phase 4
Intervention: Choline Alfoscerate
Conditions: Mild Cognitive Impairment
Sponsor: Chong Kun Dang Pharmaceutical
Enrollment: 418
Locations: 1
Primary Endpoint: The proportion of subjects whose cognitive function is maintained/improved at 48 weeks compared to baseline
Status: Not yet recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 30, 2021

End Date

November 30, 2024

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chong Kun Dang Pharmaceutical

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Choline Alfoscerate

Intervention: Choline Alfoscerate

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

The proportion of subjects whose cognitive function is maintained/improved at 48 weeks compared to baseline

Time Frame: 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 Outcomes

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)
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)
The change of CDR-SB score at 48 weeks compared to baseline(Baseline to 48 weeks)