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NCT Number: NCT07485153

A Study to Compare Two Different Sleep Tests in Participants With No Symptoms or Early Symptoms of Alzheimer's Disease

The purpose of this study is to compare the results of two different sleep tests in Alzheimer's patients with no symptoms or early symptoms. Participants will undergo two simultaneous sleep tests (polysomnography) in a sleep laboratory for two nights and one sleep test at home for three nights. For each participant, the study will last at least a week and will last up to three months.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Mobile EEG

Device

Device measures electrical activity in the brain, pulse rate, blood oxygen saturation levels, changes in blood flow and volume, motion and snoring.

Other names: Somfit

Activity monitor

Device

Device monitors physical movement.

Other names: ActiGraph LEAP Activity Monitor

Sleep Study

Device

In-Laboratory overnight assessment using EEG, electromyography to measure muscle movement, eye movement, electrical activity in the heart, blood oxygen saturation levels and breathing levels.

Other names: Polysomnography

Primary outcomes

  1. Percentage of Agreement between Participants with the Same Results in Sleep Staging Using EEG and Sleep Study

    Time frame: Night 1, Night 2

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Study to Assess the Use of the Somfit, an Ambulatory Electroencephalogram-Based Digital Health Technology, Compared With Polysomnography to Evaluate Sleep Architecture in Individuals With Asymptomatic or Early Alzheimer's Disease

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 20, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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