Memory Support System for Older Chinese Americans With Mild Cognitive Impairment

NCT07142499 | Recruiting

• 1 other identifier: GCO 22-1738
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The Memory Support System (MSS) from the Healthy Action to Benefit Independence \& Thinking® (HABIT) Program is an evidence-based, non-pharmacological intervention for mild cognitive impairment (MCI). Despite the clinical benefits and feasibility, the MSS was primarily developed and used with non-Hispanic White, English-speaking adults. Racial/ethnic minority groups are chronically under-enrolled in clinical trials for Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD) due to lack of linguistically and culturally appropriate adaptation of assessment measures and intervention protocols. The purpose of this research study is to examine whether the MSS from HABIT can help Chinese American older adults with mild thinking and memory problems. Target recruitment is 60 Chinese American adults who are primarily Mandarin- (n=30) and Cantonese-speaking (n=30). Forty participants will participate in the trainer-led day planner training and 20 will participate in self-study of the day planner and receive brain health education. Each participant will also be asked to identify a study partner to participate with them.

Conditions

Mild Cognitive Impairment (MCI)

Outcome Measures

Primary Outcomes (3)

• Recruitment rate

  Recruitment rate will be measured by dividing the number of enrollees over the number of total potential participants approached.

  baseline, week 1 of intervention session

• Retention rate

  Retention rate will be measured by dividing the number of enrollees who remain in the study over the total number of enrollees.

  baseline, treatment end (4-9 weeks)

• Completion rate

  Completion rate will be measured by dividing the number of enrollees who complete all study procedures over the number of total enrollees.

  baseline, treatment end (4-9 weeks)

Secondary Outcomes (11)

• Everyday Cognition questionnaire

  at baseline, treatment end (4-9 weeks), and 8-week follow-up

• Functional Activities Questionnaire (FAQ)

  at baseline, treatment end (4-9 weeks), and 8-week follow-up

• The Pillbox Test

  at baseline, treatment end (4-9 weeks), and 8-week follow-up

• Dementia Rating Scale-2 (DRS-2)

  at baseline, treatment end (4-9 weeks), and 8-week follow-up

• Chronic Disease Self-Efficacy Scales

  at baseline, treatment end (4-9 weeks), and 8-week follow-up

Study Arms (2)

MSS Intervention Group

EXPERIMENTAL

10-session MSS Training Workbook. Additional sessions beyond the standard 10 sessions can be added up to a maximum of 15 total sessions.

Behavioral: Memory Support System

Brain Health Education Control Group

ACTIVE COMPARATOR

10 session Brain Health Education. Additional sessions beyond the standard 10 sessions can be added up to a maximum of 15 total sessions.

Behavioral: Brain Health Education

Interventions

Memory Support System BEHAVIORAL

Participants and study partners in the MSS treatment group will work with a study trainer to learn the MSS and eventually adapt the skills to support functioning in their daily life. The MSS trainer will follow a 10-session MSS Training Workbook as the standardized protocol for training. Additional sessions beyond the standard 10 sessions can be added if needed to support mastery of the MSS (up to a maximum of 15 total sessions). Participants and study partners will also receive a copy of the brain health education workbook that contains the same educational information for the control group at the 8-week follow up.

Also known as: MSS

MSS Intervention Group

Brain Health Education BEHAVIORAL

Participants and study partners in the control group will be provided with the MSS guidebook and day planner for self-study of the MSS system. They will also meet with a study trainer to complete 10 sessions of a brain health education course that is tailored for individuals with MCI. The trainer will use a HABIT-based brain health education workbook to provide the content. Additional sessions beyond the standard 10 sessions can be added up to a maximum of 15 total sessions. Participants and study partners will receive a copy of the brain health education workbook at the 8-week follow up.

Brain Health Education Control Group

Eligibility Criteria

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

You may qualify if:

• self-identify as Chinese American;
• age 55 and above;
• a diagnosis of MCI as confirmed through documented clinical assessment and/or research-based diagnostic criteria;
• predominantly Cantonese- or Mandarin-speaking;
• able to read and write in Chinese;
• visual and auditory acuity adequate for cognitive testing;
• willing to complete the assessment measures;
• having someone in regular contact to serve as a study partner/informant;
• absence or stable use of prescribed memory-enhancing medications within the last 3 months.

You may not qualify if:

• any significant neurologic disease that would impact their participation and completion of the trial;
• history of psychiatry disorder (DSM 5 criteria) within the last 12 months;
• history of reading or writing disability sufficient to interfere with MSS training; or
• concurrent participation in another relevant clinical trial.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Li Lab, Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Clara Li, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clara Li, PhD

CONTACT

212-585-4631; clara.li@mssm.edu

Xinyi Zhang, MA

CONTACT

917-656-4981; xinyi.zhang@mssm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 26, 2025
• Study Start: July 29, 2025
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: November 6, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)