protocolSection identificationModule nctId: NCT06340659, orgStudyIdInfo id: AE and CT, briefTitle: Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in At-risk Older Adults (The Exergames Telerehabilitation Study), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2027-07-01, completionDateStruct date: 2027-07-01, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: University of Minnesota, class: OTHER, descriptionModule briefSummary: 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.The first purpose is to develop a fully-featured version of the Virtual Reality Cognitive Training (VRCT) aspect of the Exergame that can be installed and updated remotely. We will build on the Phase II Exergame by creating the capability that allows it to be installed and updated remotely to facilitate home-based use, especially by older adults. This also helps address a strong preference from our Phase II participants to minimize interaction with outsiders due to the ongoing COVID-19 pandemic, indicating a home- based solution will greatly facilitate commercialization. The second purpose is to determine the efficacy of the Home-based (Hb)Exergame on cognition and aerobic fitness in older adults at risk for AD using a 2:2 factorial design clinical trial. We will measure the following outcomes quantitatively: a) cognition: fluid cognition (global cognition) as the primary outcome, processing speed and other cognitive domains as secondary outcomes; b) aerobic fitness, c) neuroprotective blood biomarkers., conditionsModule conditions: AD-dementia, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: This study will use a single-blind, randomized, 2:2 factorial design. will randomize 104 community-dwelling older adults to one of four arms for 3 months: home-based (asynchronous) Exergame (HbExergame), supervised Exergame, home-based asynchronous aerobic exercise (HbAEx, or supervised aerobic exercise (supervised AEx). Randomization will allocate subjects on a 1:1:1:1 allocation ratio within each age stratum (65-74 and ≥75) in random blocks of 8 or 4, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 104, type: ESTIMATED, armsInterventionsModule interventions name: Supervised AEx, interventions name: HbAEx, interventions name: Supervised Exergame, interventions name: HbExergame, outcomesModule primaryOutcomes measure: fluid cognition (global cognition), secondaryOutcomes measure: Cognitive Function, secondaryOutcomes measure: Aerobic fitness, secondaryOutcomes measure: Neuroprotective biomarkers and ApoE status., secondaryOutcomes measure: Exergame-specific usability and satisfaction, secondaryOutcomes measure: Standing balance, secondaryOutcomes measure: Four-meter walking velocity, secondaryOutcomes measure: Repeated chair raise, secondaryOutcomes measure: Quality of Life (QoL), secondaryOutcomes measure: SCD Symptoms, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False