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

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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Drug: Choline Alfoscerate; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 418
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: JaeHong Lee, MD; Phone Number: +82-2-3010-3446; Email: jhlee@amc.seoul.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center Institutional Review Board
    • Contact: JaeHong Lee, MD; Phone Number: +82-2-3010-3446; Email: jhlee@amc.seoul.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo of Choline Alfoscerate 400mg per oral 3 times a day during the entire treatment period.
Experimental: Choline Alfoscerate	Drug: Choline Alfoscerate; Choline Alfoscerate 400mg per oral 3 times a day during the entire treatment period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 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	The Modified ADAS-Cog 13 scale has a total of 85 points, and the higher the score, the higher the severity.	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 K-MMSE-2 score at 24 to 48 weeks compared to baseline	K-MMSE-2 scale has a total of 30 points, and the lower the score, the higher the severity.	Baseline, 24 weeks, 48 weeks
The change of CDR-SB score at 48 weeks compared to baseline	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.	Baseline to 48 weeks

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Collaborators: Choline Alfoscerate Re-evaluation Consortium (57 pharmaceutical companies)
• Investigators: Principal Investigator: JaeHong Lee, MD, Asan Medical Center Institutional Review Board

Study record dates

Study Major Dates

• Study Start (Anticipated): September 30, 2021
• Primary Completion (Anticipated): November 30, 2024
• Study Completion (Anticipated): November 30, 2024

Study Registration Dates

• First Submitted: September 3, 2021
• First Submitted That Met QC Criteria: September 3, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Actual): September 20, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Mild Cognitive Impairment; Choline Alfoscerate
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Gastrointestinal Agents; Hypolipidemic Agents; Lipid Regulating Agents; Nootropic Agents; Lipotropic Agents; Choline
• Other Study ID Numbers: B78_02MCI2003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No