At Risk for AD-dementia, With Subjective Cognitive DeclineNCT06340659
Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in At-risk Older Adults (The Exergames Telerehabilitation Study)
A study testing HbAEx and HbExergame in people with At Risk for AD-dementia, With Subjective Cognitive Decline, run by University of Minnesota at 1 site in United States.
Trial summary
Significance of Research Question/Purpose: Subjective cognitive decline (SCD) is regarded as the first clinical manifestation in the AD-dementia continuum and currently has a prevalence of 11.2% in adults over the age of 45, with incidence increasing with greater age. Read more about this study
- Who is it for?
- Ages 65 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- At Risk for AD-dementia, With Subjective Cognitive Decline
- What is being tested?
- HbAEx and HbExergame
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2024to 30 Nov 2026
- 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 65 to 99 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Cognitive complaint (defined as answering yes to the questions's "Do you perceive memory or cognitve difficulties?" and "In the last two years, has your cognition or memory declined?";
- Montreal Cognitive Assessement (MoCA) 26 or greater
- Age 65 years and older;
- English-speaking;
- Without ACSM contraindication to exercise
Who cannot join
- Dementia or mild cognitive impairment diagnosis;
- Neurological or major psychiatric disorder, alcohol/chemical dependency or recent medical condition (anethesia COVID-19 ["brain fog"]) likely causing cognitive impairment;
- Current enrollment in another intervention study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
Significance of Research Question/Purpose: Subjective cognitive decline (SCD) is regarded as the first clinical manifestation in the AD-dementia continuum and currently has a prevalence of 11.2% in adults over the age of 45, with incidence increasing with greater age. Furthermore, population-based studies suggest that between 50% and 80% of older individuals (aged 70 years and older) who perform normally on cognitive tests, report some form of perceived decline in cognitive functioning when asked. The SCD state is unique as this population is more likely than their healthy peers to present with AD biomarkers such as neurodegeneration and amyloid burden, and therefore represents probable preclinical AD relative to other causes of SCD. Likewise, growing evidence suggests that a significant proportion of those adults are subsequently found to develop MCI, or AD, following the classic SCD-MCI-AD trajectory, with SCD increasing MCI risk 1.5-3 fold. Preventing Alzheimer's disease (AD) is arguably the most important approach to address the dementia epidemic worldwide because 99.6% of drug trials failed and no drugs can yet prevent, cure, or even slow AD. A treatment that delays the onset of AD by five years could save $89 billion in 2030.This highlights an urgent and pressing need to develop behavioral interventions to prevent AD and slow its progression.
This study will use a randomized, 2-parallel group, trial design that is guided by the Consolidated Standards of Reporting Trials (CONSORT)and the SPIRIT checklist. We will randomize 104 community-dwelling older adults to one of two arms for 3 months: home-based (asynchronous telerehabilitation) Exergame (HbExergame) or home-based (asynchronous telerehabilitation) aerobic exercise (HbAEx). Randomization will allocate subjects on a 1:1 allocation ratio within each age stratum (65-74 and >75), and will use permuted blocks of 8 and 4. We do not expect equal numbers of subjects in each age stratum, but want to balance the groups for each age. Investigators will be blinded to group assignment. All participants will be blinded to study aims and reminded as needed not to discuss their experiences with outcome assessors. Outcome assessors (also blinded to group allocations) will measure: 1) feasibility (attendance, adherence to exercise dose, systems usability scale), 2) preliminary cognition: fluid cognition [primary outcome], attention, episodic memory, and processing speed [secondary outcomes] using the NIH Toolbox cognition battery and aerobic fitness [VO2peak and 6-minute walk distance], and 3) blood neurotrophic biomarkers.
- Being tested
- HbAEx, HbExergame
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HbAExBehavioural
Participants will have a 1-week (3 session) on-boarding period where study interventionists will deliver all necessary equipment (bike, pulse oximeters, etc.) to the participants' home, review the AEx program and prescription, and supervise the first 3 sessions to ensure participant understanding and fidelity of the AEx program. Thereafter, the remaining 33 sessions will be conducted by the participant without the direct supervision (asynchronous telerehabilitation) of the study interventionists. Subjects will cycle on recumbent stationary cycles at moderate-vigorous intensity individualized as 50-70% of heart rate reserve (HRR) and/or 11-14 on Borg Category Ratio-15 Rating of Perceived Exertion (RPE) Scale, for 30-50 minutes per session. Following the completion of each session, during the check-in meeting with the participant, the study interventionist will gather information from the participant (including HR and RPE) for dose quantification.
HbExergameBehavioural
Participants will cycle as described in the HbAEx protocol while engaging in cognitive training for the duration of cycling. Cognitive training will include 20 levels of difficulty with 8-10 task scenarios in the context of three virtual worlds (environments. In each of the environments, the participant must follow directions and navigate to a destination where the scenario (cognitive task) will be performed. The game will inform the participant of the assigned task and, automatically, determine and inform the participant of the fastest route from the starting point to the scenario destination where the task will be performed. The participant will be required to remember the assigned task, follow the directions and navigate to the destination, and then remember what action is required to complete the task. A scenario-specific cognitive task will be triggered once the destination has been reached. The cycling and cognitive tasks will be completed throughout the sessions.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Subjects randomized to HbAEX Receives: Behavioral: HbAEx |
| Group 2 | Experimental | Subjects randomized to HbExergame Receives: Behavioral: HbExergame |
What is being measured
The primary outcome is the main question the study is designed to answer.
fluid cognition (global cognition)
which refers to the overall cognitive ability and will be assessed with the NIH Toolbox Cognitive Battery (NIHTB-CB) and its Fluid Composite Score (convergent validity [r = 0.78] and test-retest reliability [r = 0.86)
Measured: 12 weeks
Secondary outcomes (6)
Aerobic fitness
Aerobic fitness will be evaluated by the shuttle walk test (SWT) and followed guidelines as described by Singh and colleagues. Assistive devices will be permitted, such as ankle braces, walkers, crutches, or canes. Participants will be instructed to walk a distance of 10 meters around a marking between two cones, placed 0.5 m from each endpoint.
Measured: 12 weeks
Neuroprotective biomarkers and ApoE status.
Blood samples will be obtained by venipuncture from the antecubital vein. perform biochemical analyses of the following biomarkers: 1) peripheral neuroprotective biomarkers serum brain-derived neurotrophic factor (BDNF) and plasma IGF-1; (neurotrophic) IL-6 (systemic inflammation); glial fibrillary acidic protein (GFAP) (neuroinflammation) and, 2) APOE genotypes at the end of the study to minimize the overall variance in biochemical analyses.
Measured: 12 weeks
Exergame-specific usability and satisfaction
For individuals randomized to the HbExergame groups, usability and satisfaction of the Exergame will be assessed via questionnaire.
The Systems Usability Survey contains 14 usability- related questions using Likert scale format from 1-5 with verbal anchors of strongly disagree (1), somewhat disagree (2), neutral (3), somewhat agree (4), and strongly agree (5); 4 items are reverse scored. In addition the questionnaire contains 5 satisfaction-related questions using similar scale. Verbal anchors include: very unsatisfied (1), somewhat unsatisfied (2), neutral (3), somewhat satisfied (4), and very satisfied (5). Composite scores for usability and satisfaction will be quantified. A second questionnaire, The User Engagement Scale (Long Form) will be used to assess a quality of user experience characterized by the depth of a participant's cognitive, temporal, affective and behavioral investment when interacting with a digital system. The User Engagement Scale has 3
Measured: 12 weeks
SCD Symptoms
The Subjective Cognitive Decline Questionnaire (SCD-Q), a 27-item questionnaire, assesses both subject and informant self-perceived subjective decline in memory, language, and executive function in the last two years.
Measured: 12 weeks
Anxiety Symptoms
Anxiety symptoms will be measured with the Geriatric Anxiety Scale (GAS-10) a 10-item version Likert scale (0-3 with 3 representing increased symptoms). The total GAS-10 scores range from 0 (no anxiety) to 30 (severe anxiety). It is a reliable and valid assessment for assessing anxiety symptoms with overall adequate internal consistency (Cronbach's alpha of 0.93)
Measured: 12 weeks
Depressive Symptoms
Depression symptoms will assessed with the 15-item dichotomous (yes/no) Geriatric Depression Scale Short Form (GDS-SF). The GDS-SF scores range from 0 (no depression) to 15 (severe depression). It is a reliable and valid assessment for assessing depression symptoms with overall adequate internal consistency (Cronbach's alphas of 0.74-0.76) and statistically significant construct validity (dimensionality coefficients of 0.94).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start14 Aug 2024
- Primary completion31 Aug 2026
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for At Risk for AD-dementia, With Subjective Cognitive DeclineStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This study will use a single-blind, randomized trial will randomize 104 community-dwelling older adults to one of two arms for 3 months: home-based (asynchronous) Exergame (HbExergame) or home-based asynchronous aerobic exercise (HbAEx). Randomization will allocate subjects on a 1:1 allocation ratio within each age stratum (65-74 and ≥75) in random blocks of 8 or 4
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340659
- Sponsor's protocol ID
- AE and CT
- Status last verified
- Aug 2026
- First submitted
- 8 Mar 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in At-risk Older Adults (The Exergames Telerehabilitation Study)
- ClinicalTrials.gov ID
- NCT06340659
- Acronym / sponsor ID
- AE and CT
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Significance of Research Question/Purpose: Subjective cognitive decline (SCD) is regarded as the first clinical manifestation in the AD-dementia continuum and currently has a prevalence of 11.2% in adults over the age of 45, with incidence increasing with greater age. Furthermore, population-based studies suggest that between 50% and 80% of older individuals (aged 70 years and older) who perform normally on cognitive tests, report some form of perceived decline in cognitive functioning when asked. The SCD state is unique as this population is more likely than their healthy peers to present with AD biomarkers such as neurodegeneration and amyloid burden, and therefore represents probable preclinical AD relative to other causes of SCD. Likewise, growing evidence suggests that a significant proportion of those adults are subsequently found to develop MCI, or AD, following the classic SCD-MCI-AD trajectory, with SCD increasing MCI risk 1.5-3 fold. Preventing Alzheimer's disease (AD) is arguably the most important approach to address the dementia epidemic worldwide because 99.6% of drug trials failed and no drugs can yet prevent, cure, or even slow AD. A treatment that delays the onset of AD by five years could save $89 billion in 2030.This highlights an urgent and pressing need to develop behavioral interventions to prevent AD and slow its progression.
This study will use a randomized, 2-parallel group, trial design that is guided by the Consolidated Standards of Reporting Trials (CONSORT)and the SPIRIT checklist. We will randomize 104 community-dwelling older adults to one of two arms for 3 months: home-based (asynchronous telerehabilitation) Exergame (HbExergame) or home-based (asynchronous telerehabilitation) aerobic exercise (HbAEx). Randomization will allocate subjects on a 1:1 allocation ratio within each age stratum (65-74 and >75), and will use permuted blocks of 8 and 4. We do not expect equal numbers of subjects in each age stratum, but want to balance the groups for each age. Investigators will be blinded to group assignment. All participants will be blinded to study aims and reminded as needed not to discuss their experiences with outcome assessors. Outcome assessors (also blinded to group allocations) will measure: 1) feasibility (attendance, adherence to exercise dose, systems usability scale), 2) preliminary cognition: fluid cognition [primary outcome], attention, episodic memory, and processing speed [secondary outcomes] using the NIH Toolbox cognition battery and aerobic fitness [VO2peak and 6-minute walk distance], and 3) blood neurotrophic biomarkers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study will use a single-blind, randomized trial will randomize 104 community-dwelling older adults to one of two arms for 3 months: home-based (asynchronous) Exergame (HbExergame) or home-based asynchronous aerobic exercise (HbAEx). Randomization will allocate subjects on a 1:1 allocation ratio within each age stratum (65-74 and ≥75) in random blocks of 8 or 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: HbAExSubjects randomized to HbAEX |
| Group 2 | Experimental | Behavioral: HbExergameSubjects randomized to HbExergame |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Cognitive complaint (defined as answering yes to the questions's "Do you perceive memory or cognitve difficulties?" and "In the last two years, has your cognition or memory declined?";
- Montreal Cognitive Assessement (MoCA) 26 or greater
- Age 65 years and older;
- English-speaking;
- Without ACSM contraindication to exercise
Key exclusion criteria (3 listed)
- Dementia or mild cognitive impairment diagnosis;
- Neurological or major psychiatric disorder, alcohol/chemical dependency or recent medical condition (anethesia COVID-19 ["brain fog"]) likely causing cognitive impairment;
- Current enrollment in another intervention study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HbAExParticipants will have a 1-week (3 session) on-boarding period where study interventionists will deliver all necessary equipment (bike, pulse oximeters, etc.) to the participants' home, review the AEx program and prescription, and supervise the first 3 sessions to ensure participant understanding and fidelity of the AEx program. Thereafter, the remaining 33 sessions will be conducted by the participant without the direct supervision (asynchronous telerehabilitation) of the study interventionists. Subjects will cycle on recumbent stationary cycles at moderate-vigorous intensity individualized as 50-70% of heart rate reserve (HRR) and/or 11-14 on Borg Category Ratio-15 Rating of Perceived Exertion (RPE) Scale, for 30-50 minutes per session. Following the completion of each session, during the check-in meeting with the participant, the study interventionist will gather information from the participant (including HR and RPE) for dose quantification. | Behavioural | Group 1 |
| HbExergameParticipants will cycle as described in the HbAEx protocol while engaging in cognitive training for the duration of cycling. Cognitive training will include 20 levels of difficulty with 8-10 task scenarios in the context of three virtual worlds (environments. In each of the environments, the participant must follow directions and navigate to a destination where the scenario (cognitive task) will be performed. The game will inform the participant of the assigned task and, automatically, determine and inform the participant of the fastest route from the starting point to the scenario destination where the task will be performed. The participant will be required to remember the assigned task, follow the directions and navigate to the destination, and then remember what action is required to complete the task. A scenario-specific cognitive task will be triggered once the destination has been reached. The cycling and cognitive tasks will be completed throughout the sessions. | Behavioural | Group 2 |
Primary outcome
fluid cognition (global cognition)
Time frame: 12 weeks
which refers to the overall cognitive ability and will be assessed with the NIH Toolbox Cognitive Battery (NIHTB-CB) and its Fluid Composite Score (convergent validity [r = 0.78] and test-retest reliability [r = 0.86)
6 secondary outcomes
Aerobic fitness
Time frame: 12 weeks
Neuroprotective biomarkers and ApoE status.
Time frame: 12 weeks
Exergame-specific usability and satisfaction
Time frame: 12 weeks
SCD Symptoms
Time frame: 12 weeks
Anxiety Symptoms
Time frame: 12 weeks
Depressive Symptoms
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HbAEx and HbExergame in people with At Risk for AD-dementia, With Subjective Cognitive Decline, run by University of Minnesota 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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 1 Sep 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fluid cognition (global cognition) (time frame: 12 weeks). 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 1 Sep 2026.