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NCT06340659 · ClinicalTrials.gov registry record · NA

Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in At-risk Older Adults (The Exergames Telerehabilitation Study)

A NA study of At Risk for AD-dementia, With Subjective Cognitive Decline, sponsored by University of Minnesota.

Recruiting
Registry status
NA
Development phase
104
Enrollment target
1
Study location

NCT06340659: Recruiting NA study of At Risk for AD-dementia, With Subjective Cognitive Decline, sponsored by University of Minnesota.

NCT06340659 is a NA study of At Risk for AD-dementia, With Subjective Cognitive Decline that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 104 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06340659, a NA study of At Risk for AD-dementia, With Subjective Cognitive Decline, is actively recruiting participants, sponsored by University of Minnesota.

RECRUITING
Registry status
NA
Development phase
104 participants
Enrollment target
1
Study location

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

Primary Outcome

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)

Interventions

  • BEHAVIORAL HbAEx
  • BEHAVIORAL HbExergame

Study Locations (1)

Minnesota

  • University of Minnesota - Minneapolis

Trial Details

FieldValue
Enrollment Target 104 participants
Start Date 2024-08-14
Est. Completion 2026-09-30
Phase NA
University of Minnesota

966 total trials

What NCT06340659 shows while recruiting

NCT06340659 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).

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.

NCT06340659 reports a single indexed study location in Minnesota.

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.

What interventions are being tested in trial NCT06340659?

The interventions under investigation include: HbAEx (BEHAVIORAL), HbExergame (BEHAVIORAL).

Who is sponsoring clinical trial NCT06340659?

This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.

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.

How this trial's enrollment target compares

Where NCT06340659's enrollment target sits among peer trials

104 836th of 2000 higher than 1,164 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06340659, the US trial registry maintained by the National Library of Medicine. NCT06340659 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.