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Life sciences · Interventional Study
ClinicalTrials.gov · September 23, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT04855630). This is a study registration, not published results. Lead sponsor: University of Miami. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 60 participants (ESTIMATED). Conditions: Dementia, Mild Cognitive Impairment (MCI), Cognitively Unimpaired, Alzheimer's Dementia (AD). Interventions: DEVICE: Elemind Neuromodulation Headband; OTHER: Exercise Routine. Primary outcome measures: Glycated Hemoglobin (HbA1c) Levels , Up to Week 8; Total Cholesterol Levels , Up to Week 8; Triglycerides Levels , Up to Week 8; High-sensitivity C-reactive protein (hs-CRP) Levels , Up to Week 8; Low-Density Lipoprotein (LDL) Levels , Up to Week 8; C-Peptides , Up to Week 8; High-Density Lipoprotein (HDL) Levels , Up to Week 8; Cognitive Function , Up to 8 weeks; Insulin Levels , Up to 8 weeks; Neurofilament light chain , Up to Week 8. Brief summary: 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.