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NCT04855630From ClinicalTrials.govRecruiting

Combating Alzheimer's Through Sleep and Exercise

Combating Alzheimer's Through Sleep and Exercise (CASE)

  • Dementia
  • Mild Cognitive Impairment (MCI)
  • Cognitively Unimpaired
  • Alzheimer's Dementia (AD)

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
University of Miami
Enrolment target
60
Started
1 March 2023
Main results due
30 December 2028
Study sites
1
Registry updated
23 September 2026

Can you take part?

  • Ages 55 years to 80 years.
  • Open to any sex.
  • Healthy volunteers can take part.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

1. Aged 55-80 years at the time of the screening visit
2. Able to ambulate safely and independently
3. Able to safely perform moderate-intensity exercise as per the Physical Activity Readiness Questionnaire (PAR-Q, a validated exercise readiness questionnaire)
4. Able to wear and use Fitbit wristwatch and/or the Elemind Neuromodulation headband and Lys devices
5. Able to operate a digital device like mobile phone or computer
6. Able and willing to provide venous blood samples
7. Able to understand and speak English (our AR-based MCI diagnosis tool does not yet have capacity for other languages)
8. Able to self-report a history of cognitive changes or impairment
9. Be cognitively able (including those with and without MCI) and willing to provide informed consent
10. Body weight \<400 pounds (\<181.4kg) in order to safely operate the NuStep T4r Recumbent Stepper stationary bicycle

Exclusion Criteria:

1. Severe mobility limitations that prevent safe participation in moderate exercise protocols
2. Unstable or uncontrolled medical conditions (e.g., recent cardiovascular event (\<6 months), cerebrovascular accident or transient ischemic attack (\<6 months), active cancer, or uncontrolled diabetes) that pose safety concerns
3. Inability to complete intake screening procedures
4. Severe uncorrected hearing impairment-particularly if it precludes effective utilization of the Elemind Neuromodulation headband-and/or vision impairment that interferes with digital device usage or in-person exercise guidance
5. Determined to have Alzheimer's/dementia based on performance on the Quick Mild Cognitive Impairment (QMCI).
6. Inability or unwillingness to learn or engage with digital devices (e.g., smartphone, Fitbit, Elemind, or Lys), even with staff support
7. Regular pre-study engagement in ≥150 minutes of moderate-level and/or ≥75 minutes of vigorous-level exercise per week based on Fitbit data obtained during the initial seven-day onboarding screening period
8. Determined to have sufficient sleep, as defined by a sleep efficiency mean of ≥80%) based on Elemind Neuromodulation headband data obtained during the initial seven-day onboarding screening period
9. Current usage of disease-modifying therapy targeting amyloid (e.g., anti-amyloid monoclonal antibodies) or tau
10. Body weight ≥400 pounds (≥181.4kg), which would pose a safety risk during the operation of the NuStep recumbent stationary bicycle

What this study is about

In the sponsor’s own words, from the registry.

The Combating Alzheimer's through Sleep and Exercise (CASE) study is an exploratory, hypothesis-generating trial designed to: (1) assess whether improvements in sleep are associated with improvements in cognitive performance and cardiovascular and metabolic health; (2) evaluate the effects of structured, moderate-level aerobic and anaerobic exercise on cognitive performance and cardiovascular and metabolic health; (3) examine the combined, potentially synergistic effects of both interventions on cognitive performance and cardiovascular and metabolic health; and (4) investigate the role of light exposure as a potential modulator of sleep parameters.

Study sites(1)

  • University of Miami Hospitals

    Miami, Florida, United States

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT04855630. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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