NCT07485153 · NOT YET RECRUITING
A Study to Compare Two Different Sleep Tests in Participants With No Symptoms or Early Symptoms of Alzheimer's Disease
This study compares two ways of measuring sleep: a mobile EEG headband-style device worn at home, and the standard overnight sleep lab test. Participants do two nights in a sleep lab and three nights at home. Nothing is being treated. It is a measurement study, and no phase was listed. The goal is to see whether the results agree.
You may qualify if
- Have mild cognitive impairment, subjective memory complaints, or normal cognition.
- Evidence of the presence of Alzheimer's pathology as measured by amyloid positron emission tomography (PET), cerebrospinal fluid biomarkers (amyloid beta and tau), or blood biomarkers.
- Montreal Cognitive Assessment (MoCA) score of 24 or greater.
- Clinical Dementia Rating Scale (CDR) global score of 0 or 0.5.
- Able to provide signed informed consent.
- On stable medications (including those for Alzheimer's disease) for 30 days before the first recording night of Study Period 1, and willing to remain on stable therapy during the study.
- Must have a study partner who knows the participant well and can accompany the participant at visits where informant-rated scales are administered.
You're excluded if
- Severe illness that in the investigator's judgement would adversely affect the participant's participation in the study.
- Skin illness that may interfere with study assessments.
- Has a pacemaker or implantable cardioverter defibrillator.
- Diagnosed with a sleep disorder.
- Has irregular circadian patterns (works night shifts, etc.).
- Is pregnant or lactating/breastfeeding at time of screening.
- Use of sleep aid medications (such as melatonin, Ambien, Lunestra) or other medications or substances that could affect sleep (alcohol, cannabinoids, or opioids) on nights of in-clinic and at-home recordings.
- Currently enrolled in another clinical study involving an investigational product or other type of medical research judged not to be scientifically or medically compatible with this study.
- People who habitually spend less than 5 hours in bed per night.
- No alcohol will be allowed at least 24 hours before the use of the EEG and throughout the clinical assessment period.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-03-20