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Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in At-risk Older Adults (The Exergames Telerehabilitation Study)
NCT06340659 · View on ClinicalTrials.gov ↗
Study 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. 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 g
Conditions Studied
Interventions
- BEHAVIORAL HbAEx
- BEHAVIORAL HbExergame
Study Locations (1)
Minnesota
- University of Minnesota — Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2024-08-14 |
| Est. Completion | 2026-09-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06340659
The ClinicalTrials.gov registry entry for NCT06340659 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 919 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with At Risk for AD-dementia, With Subjective Cognitive Decline appearing as the primary indexed condition, and to 2 interventions — of which HbAEx is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06340659 reports 1 study location spanning 1 distinct geographic area — top geographies include Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06340659 about?
NCT06340659 is a clinical study titled "Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in At-risk Older Adults (The Exergames Telerehabilitation 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 s...
What is the current status of trial NCT06340659?
This trial is currently recruiting. It is a NA study. The enrollment target is 104 participants. The study started on 2024-08-14. Estimated completion is 2026-09-30.
What conditions does trial NCT06340659 study?
This clinical trial studies the following conditions: At Risk for AD-dementia, With Subjective Cognitive Decline. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06340659?
The interventions under investigation include: HbAEx (BEHAVIORAL), HbExergame (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06340659?
This trial is sponsored by University of Minnesota, which has 919 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06340659 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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