NCT05380739

Brief Summary

This study will evaluate the efficacy of working memory training in older adults with amnestic mild cognitive impairment (MCI).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 7, 2022

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 19, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2023

Completed
Last Updated

October 20, 2025

Status Verified

October 1, 2025

Enrollment Period

1.1 years

First QC Date

April 27, 2022

Last Update Submit

October 16, 2025

Conditions

Keywords

Working MemoryTrainingfMRI

Outcome Measures

Primary Outcomes (2)

  • Gains in WM training task performance

    Analyses of WM performance for each training session indexed as the mean set-size achieved during each training session for each participant

    2 weeks

  • Changes in brain activation within the WM network

    Univariate analyses via fMRI and fNIRS, respectively, using units of brain activation (i.e., contrast estimates)

    2 weeks

Secondary Outcomes (2)

  • Changes in criterion (fMRI) WM task performance

    2 weeks

  • Changes in functional connectivity within and between canonical brain networks

    2 weeks

Study Arms (3)

In-Person, MCI

ACTIVE COMPARATOR

Participants diagnosed with MCI will undergo 10 sessions of WM training in person.

Behavioral: Working Memory Training

Online, MCI

ACTIVE COMPARATOR

Participants diagnosed with MCI will undergo 10 sessions of WM training online.

Behavioral: Working Memory Training

Online, Healthy

ACTIVE COMPARATOR

Cognitively intact older adults will undergo 10 sessions of WM training online.

Behavioral: Working Memory Training

Interventions

A 10-session working memory (WM) training program

In-Person, MCIOnline, HealthyOnline, MCI

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • MCI Diagnosis
  • Right-handedness
  • MRI-eligibility for MRI participants

You may not qualify if:

  • History of other contributing neurological or medical conditions known to affect cognitive functioning
  • Significant mental illness
  • Sensory impairments that limit ability to participate
  • History of alcohol or drug abuse/dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Alexandru Iordan, Ph.D.

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants in the MCI group will be assigned to receive either in-person (Arm1) or online WM training (Arm2), based on their preference and availability of equipment ensuring a stable internet connection, for 10 training sessions. Participants in the HC group will receive online training (Arm3). Data for HC who received in-person training was already collected (HUM00033133). WM performance in conjunction with brain imaging will be assessed within-subject, twice pre-training (Time1 and Time2) and once post-training (Time3), as well as \~1 month after training (Follow-up). The Time1 vs. Time2 comparison will reveal task-exposure effects, whereas the Time2 vs. Time3 comparison will reveal training effects.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 27, 2022

First Posted

May 19, 2022

Study Start

April 7, 2022

Primary Completion

May 11, 2023

Study Completion

May 11, 2023

Last Updated

October 20, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations