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MCINCT07160582

Cognitive-Motor Training for AD/ADRD Prevention

A study testing Novel CogXergaming Training and Exercise and Education Training Program in people with MCI and Aging, run by University of Illinois at Chicago at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Alzheimer's disease and related dementias (AD/ADRD) greatly affect memory and daily activities in older adults. Mild Cognitive Impairment (MCI) is an early stage of dementia, affecting about 17% of older adults. Read more about this study

Who is it for?
Ages 55 to 90 yearsHealthy volunteers can take part
Conditions the study is for
MCI, Aging
What is being tested?
Novel CogXergaming Training and Exercise and Education Training Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteUnited States
Study dates
1 Oct 2026to 1 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age: 55-90 years.
  • No recent major surgery, bone fracture, or hospitalization (< 3 months).
  • Not on any sedative drugs.
  • Can understand and communicate in English.
  • Can walk without an assistive device for at least 1 block to ensure independent functioning.
  • Identification of Mild Cognitive Impairment (MCI) based on Jak/Bondi criteria
  • Visual acuity greater than or equal to 20/40 with or without corrective lenses to ensure intact vision.

Who cannot join

  • Participants will not proceed with the study if any of the following occurs at baseline measurement: 1) Heart Rate >85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age), 2) systolic blood pressure (SBP) > 160 mmHg and/or diastolic blood pressure (DBP) > 110 mmHg during resting.
  • Unable to stand for 5 minutes without an assistive device and walk for 10 m without an assistive device
  • Complaints of shortness of breath, or uncontrolled pain (more than 3 out of 10 on Visual Analogue Scale), or if pulse oxygen drops less than 92% on the six-minute walk test (for endurance) to ensure that the participant can effectively participate without discomfort or injury during testing and training.
  • Exhibits difficulty understanding the study information.
  • Self-reported history or presence of any neurological, musculoskeletal, cardiorespiratory, or systemic disorders that significantly impact mobility or the ability to walk independently (without an assistive device).
  • Self-reported disability (with or without an assistive device) to ensure independent functioning.
  • Uncontrolled (not under any medications) hypertension to avoid cardiovascular complications during testing/training.
  • Weight >220 lbs (harness weight threshold).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shuaijie Wang, PhD contact

3123554674

sjwang4@uic.edu

United States1 site
  • University of Illinois at Chicago

    Chicago, Illinois, 60612

    Shuaijie Wang, 3123554674, sjwang4@uic.edu

Other trials in United States

About this study

Official title: Innovative Cognitive-Motor Training for Prevention of AD/ADRD

Alzheimer's disease and related dementias (AD/ADRD) greatly affect memory and daily activities in older adults. Mild Cognitive Impairment (MCI) is an early stage of dementia, affecting about 17% of older adults. People with MCI often show problems with gait and balance, which doubles their risk of falling compared to cognitively healthy peers. Falls can cause injuries, increase sedentary behavior, and reduce physical activity. This decline in activity can also speed up the progression from MCI to dementia. Exercise can help older adults make healthy lifestyle changes; however, most of the existing exercise programs focus mainly on physical movement rather than cognitive function. Therefore, the investigators developed a new program that uses computer vision and a cloud-based system to provide more scalable, engaging, and personalized cognitive-motor training for OAwMCI. The purpose of this study is to investigate the short- and long-term effects of a novel CogXergaming training (CXT) paradigm for improving the cognitive-motor function, physical activity, falls efficacy, and quality of life.

Read the detailed description

Alzheimer's disease/Alzheimer's disease and related dementias (AD/ADRD) significantly impair cognitive function and the ability to perform activities of daily living in older adults. Mild Cognitive Impairment (MCI) is a transitional phase between age-associated cognitive decline and dementia, which affects about 17% of older adults and can impair multiple domains of cognitive functioning (executive function, memory, etc.). Further, there is a well-established relationship between cognitive decline and reduced mobility, and OAwMCI show gait and balance deficits compared to cognitively intact older adults (CIOA), resulting in a 2-fold increase in the risk of falling. Fall-related consequences (e.g., injury) can significantly increase sedentary behavior and reduce physical activity, thus leading to a vicious cycle of deconditioning and reduced mobility, which significantly increases the risk of experiencing another fall. Further, sedentary behavior and deconditioning can accelerate the rate of conversion from MCI to AD/ADRD.

Exercise interventions are a promising approach to not only improve motor function, balance, and mobility in OAwMCI but also to improve cognitive function via several mechanisms of action. However, few exercise interventions for OAwMCI explicitly target cognitive processing in challenging conditions, such as dual tasking (i.e., simultaneous motor+cognitive task). Exergaming is a form of dual-task training that could reduce CMI in OAwMCI by providing combined cognitive stimulation and motor training in challenging environments that activate multiple cognitive processes, using digital gaming platforms. However, most existing exergames have focused only on the physical domain (promoting physical activity or exercise), and there is limited evidence on whether exergaming yields more cognitive benefit than conventional training. To explicitly target cognitive function and dual tasking ability, the investigators have developed a novel paradigm that integrates advanced computer vision technology and a cloud-based platform to provide more scalable, engaging, and customizable cognitive-motor training for OAwMCI. This CXT paradigm overcomes barriers of commercial exergaming systems (Wii Fit, Kinect) and requires minimal technology (webcam, computer/tablet), thus being more scalable and cost-effective.

The current proposal will examine the effects of 8 weeks of CXT on dual tasking ability, balance, and mobility, and patient-centered outcomes in OAwMCI, compared to an exercise and education program (EEP).

Aim 1: Examine the immediate effects of CXT on mechanistic measures of CMI in OAwMCI by comparing the dual task costs during both volitional and reactive balance tasks between groups after 8 weeks of training.

Aim 2: Examine the immediate effects of CXT on dynamic balance, mobility, and endurance in OAwMCI, and the investigators will also compare the cognitive function using the NIH cognitive toolbox between groups immediately after the training (Ancillary Aim).

Aim 3: Examine the immediate and sustained effects of CXT on patient-centered measures of physical activity, falls efficacy, and quality of life, and examine whether reductions in CMI (Aim 1) and improved balance, mobility, and endurance (Aim 2) will mediate improvements in patient-centered outcomes.

Exploratory analysis: To understand stakeholder (participants, clinicians) perceptions regarding CXT and facilitators/barriers for translation of the intervention into home and community settings, focus groups will be conducted to assess system usability, acceptability, attitudes, and intrinsic motivation via self-reported questionnaires and recorded transcripts.

Conditions
MCI, Aging
Being tested
Novel CogXergaming Training, Exercise and Education Training Program
Keywords
CogXergaming, Cognitive-motor interference, Dual-task

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Novel CogXergaming TrainingBehavioural

    Also called CXT

    In each session, participants will play 6 games in the same order (Fruit catch, Math, Tracking, Candy match, Letter Number Sequencing - LNS, Stroop), each of which contains 10-20 trials and will last for around 10 minutes (total = 60 minutes. The CXT program employs a progressive method to ensure the intensity of CXT remains challenging without overload. If a participant demonstrates ≥80% accuracy in 3 continuous trials for one game, then the exercises for this game will be progressed to the next level (levels: 1-9 in Table 3). Each session of CXT will last approximately 1 hour. At least one day of rest will be required between weekly training sessions.

  • Exercise and Education Training ProgramBehavioural

    Also called EEP

    EEP consists of a conventional exercise program and fall-prevention education. The conventional exercise program comprises 50 minutes of supervised exercises for stretching and strengthening. A fall-prevention education program will also be provided to Group B, for about 10 minutes after each session of the exercise program. Each session of EEP will last approximately 1 hour. At least one day of rest will be required between weekly training sessions.

Study groups in NCT07160582
Study groupRoleWhat they receive
Novel CogXergaming TrainingExperimentalCustomized Novel CogXergaming Training based on cognitive-motor balance training will be delivered to Participants in group A. Participants will undergo 18 sessions of training for eight weeks, with around 60 minutes of training per session, i.e., 3 sessions per week in the first 2 weeks, and 2 sessions per week in the remaining 6 weeks. All the CXT training will be performed using a desktop with a webcam.
Receives: Behavioral: Novel CogXergaming Training
Exercise and Education Training ProgramExperimentalParticipants in Group B will complete 8 weeks of a conventional exercise program and fall-prevention education (3x/week in the first 2 weeks and 2x/week in the remaining 6 weeks, 18 sessions total) in the lab.
Receives: Behavioral: Exercise and Education Training Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dual-task Limits of Stability Test (LOS)

    Measures changes in max excursion under dual-task conditions during the LOS test compared to the single-task.

    Measured: Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)

  2. Mini-BESTest

    Assesses 4 domains: anticipatory and reactive balance control (therapist-induced), sensory orientation, and gait.

    The value ranges from 0 to 28, and higher scores indicate better balance control.

    Measured: Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)

  3. Physical Activity Scale of Elderly (PASE)

    Self-reported measure of physical activity levels in older adults. The score ranges from 0 to 799, higher scores indicate greater physical activity level.

    Measured: Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)

  4. Activities Specific Balance Confidence (ABC)

    Assesses an individual's confidence in maintaining balance during various daily activities. The score ranges from 0 to 100, and higher scores indicate greater confidence in maintaining balance during activities

    Measured: Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)

Secondary outcomes (7)
  1. Dual-task Stance Perturbation Test (SPT)

    Measures changes in the center of pressure (COP) displacement under dual-task conditions during SPT compared to single-task conditions.

    Measured: Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)

  2. Timed up and go (TUG)

    Measures functional mobility by assessing the time taken to stand up, walk, and return to a seated position.

    Measured: Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)

  3. 6 Minute Walk Test (6MWT)

    Assesses aerobic endurance and walking ability by measuring the distance walked in 6 minutes.

    Measured: Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)

  4. NIH motor toolbox- standing balance test

    Assesses balance control during standing.

    Measured: Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)

  5. NIH motor toolbox- 4-meter walking test.

    A walking speed test that assesses for functional limitations and physical performance

    Measured: Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)

  6. 36-Item Short Form Survey (SF-36)

    Evaluates health-related quality of life, including physical and mental health components. The score ranges from 0 to 100, and higher score indicate better quality of life.

    Measured: Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)

  7. Weekly # of steps

    Tracks physical activity levels by recording the number of steps per week using pedometer

    Measured: Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2025
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion1 Oct 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Controlled design to compare the effect of two different training programs on the cognitive-motor function, physical activity, falls efficacy, and quality of life in older adults with mild cognitive impairment.
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07160582
Sponsor's protocol ID
2025-0354
Status last verified
Mar 2026
First submitted
29 Aug 2025
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Novel CogXergaming Training and Exercise and Education Training Program in people with MCI and Aging, run by University of Illinois at Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shuaijie Wang, PhD (3123554674, sjwang4@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dual-task Limits of Stability Test (LOS) (time frame: Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

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