Recruiting

MSS for MCI

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT07142499

Conditions

Mild Cognitive Impairment (MCI)

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Memory Support System

Brain Health Education

Study Details

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)

Study ID

NCT07142499

Start date

Jul 29, 2025

Status verified date

Oct, 2025

Completion date

May, 2026

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

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 include:

  • 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.

Study Design

Enrollment

7 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

Interventions

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.

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.

Primary outcome measure

  • Recruitment rate [ Time Frame: baseline, week 1 of intervention session ]
  • Retention rate [ Time Frame: baseline, treatment end (4-9 weeks) ]
  • Completion rate [ Time Frame: baseline, treatment end (4-9 weeks) ]

Central Contacts and Locations

Central contacts

Clara Li, PhD

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

Xinyi Zhang, MA

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

Locations

Li Lab, Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Shreya Upendra, MA

929-504-2324shreya.upendra@mssm.edu

Xinyi Zhang, MA

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

Principal Investigator:

Clara Li

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Nov 6, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2025-11-06.