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Combating Alzheimer's Through Sleep and Exercise

Study acronym: CASE
StatusRecruiting
PhaseNot applicable
Started2023-03-01
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoints removed 14 → 10 primary endpoints
See other at-risk trials from University of Miami

Amendment history

2026-09-24
Primary endpoint(s) modified14 to 10 entries
WasBlood Pressure, Cortisol Levels, Cortisone Levels, Creatinine Levels, HbA1c Levels, Heart Rate, High-Density Lipoprotein (HDL) Levels, High-sensitivity C-reactive protein (hs-CRP) Levels, Low-Density Lipoprotein (LDL) Levels, Melatonin Levels, Slow Wave Sleep Duration, Total Cholesterol Levels, Total Sleep Duration, Triglycerides Levels
NowC-Peptides, Cognitive Function, Glycated Hemoglobin (HbA1c) Levels, High-Density Lipoprotein (HDL) Levels, High-sensitivity C-reactive protein (hs-CRP) Levels, Insulin Levels, Low-Density Lipoprotein (LDL) Levels, Neurofilament light chain, Total Cholesterol Levels, Triglycerides Levels
Enrollment increased: 30 → 60 participants
Interventions modified
2026-04-14
Study Status v7
Primary completion date2026-03-01→2028-12-30
Completion date2026-03-01→2028-12-30
2025-02-21
Study Status, Contacts/Locations v6
Primary completion date2025-03-01→2026-03-01
Completion date2025-03-01→2026-03-01
Study sitescontacts updated at 1 of 1 site
2024-02-29
Study Status, Contacts/Locations v5
Primary completion date2024-03-01→2025-03-01
Completion date2024-03-01→2025-03-01
Study sitescontacts updated at 1 of 1 site
2023-08-31
Study Status v4
Primary completion date2023-09-01→2024-03-01
Completion date2023-09-01→2024-03-01
Show 3 earlier versions
2023-03-20
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2022-12-05
Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v2
Primary completion date2024-09-01→2023-09-01
Completion date2024-09-01→2023-09-01
Start date2022-04-01→2023-03-01
InterventionsDREEM 2 Headband (Other), Fitbit (Other)→DREEM 2 Headband (Device), Exercise Routine (Other)
Eligibility criteria-42 characters
Inclusion Criteria: Age 45 years and older Able to perform mild exercise Able to wear DREEM 2 Headband [...] ng to provide consent will be included. Exclusion Criteria: Under 45 years old Prohibited from or unable to perform mild exercise Unable to [...]
Primary endpoints20 to 14 entries
BloodCortisol PressureLevels CalculatedCortisone Low-DensityLevels Creatinine Lipoprotein (LDL) Level Calculated Low-Density Lipoprotein (LDL) LevelLevels HbA1c HbA1c Heart RateLevels High-Density Lipoprotein (HDL) LevelLevels High-Density Lipoprotein (HDL) Level Slow Wave Sleep Duration Total Cholesterol Level Total Cholesterol Level Total Sleep Duration Triglycerides Level Triglycerides Level high-sensitivity C-reactive protein (hs-CRP) LevelLevels highLow-sensitivityDensity C-reactive proteinLipoprotein (hs-CRPLDL) LevelLevels Melatonin Levels Total Cholesterol Levels Triglycerides Levels
Study sites1 entry, revised
NYUUniversity Langoneof HealthMiami Hospitals
Collaborators+24 characters
Shipley Foundation Dreem
2022-01-05
Study Identification, Study Status, Sponsor/Collaborators v1
Primary completion date2021-11-01→2024-09-01
Completion date2021-11-01→2024-09-01
Start date2021-05-01→2022-04-01
Lead sponsorNYU Langone Health→University of Miami
2021-04-19
Original filing
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.
Trial Details
NCT Number NCT04855630
Lead Sponsor University of Miami
Collaborators: Shipley Foundation, Elemind Technologies, Inc., Fitbit LLC, Altoida
Conditions Dementia, Mild Cognitive Impairment (MCI), Cognitively Unimpaired, Alzheimer's Dementia (AD)
Enrollment 60 participants
Start Date 2023-03-01
Primary Completion 2028-12-30 (estimated)
Study Completion 2028-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-23