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

Mild Cognitive Impairment Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05041790
• Other study ID #: B78_02MCI2003
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 30, 2021
• Est. completion date: November 30, 2024

Study information

• Verified date: September 2021
• Source: Chong Kun Dang Pharmaceutical
• Contact: JaeHong Lee, MD
• Phone: +82-2-3010-3446
• Email: jhlee[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 418
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center Institutional Review Board	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical	Choline Alfoscerate Re-evaluation Consortium (57 pharmaceutical companies)

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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