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Memory Support System for Older Chinese Americans With Mild Cognitive Impairment

NCT ID: NCT07142499

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-29

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Mild Cognitive Impairment (MCI)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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MSS Intervention Group

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

Group Type EXPERIMENTAL

Memory Support System

Intervention Type 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.

Brain Health Education Control Group

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

Group Type ACTIVE_COMPARATOR

Brain Health Education

Intervention Type 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.

Interventions

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Memory Support System

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.

Intervention Type BEHAVIORAL

Brain Health Education

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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MSS

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Clara Li

Associate Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Clara Li, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Li Lab, Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Clara Li, PhD

Role: CONTACT

Phone: 212-585-4631

Email: [email protected]

Xinyi Zhang, MA

Role: CONTACT

Phone: 917-656-4981

Email: [email protected]

Facility Contacts

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Shreya Upendra, MA

Role: primary

Xinyi Zhang, MA

Role: backup

Other Identifiers

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GCO 22-1738

Identifier Type: -

Identifier Source: org_study_id