NCT07485153Not yet recruiting
A Study to Compare Two Different Sleep Tests in Participants With No Symptoms or Early Symptoms of Alzheimer's Disease
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
Source: ClinicalTrials.gov · Last updated 20 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 35 (estimated)
- First submitted
- 5 Feb 2026
- Start date
- 1 Mar 2026
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Alzheimer disease
- NCT number
- NCT07485153
What you commit to
- Study type: Observational
- Planned participants: 35
- From 1 Mar 2026 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
- Diagnosed with a sleep disorder.
Other
- Has a pacemaker or implantable cardioverter defibrillator.
- Has irregular circadian patterns (works night shifts, etc.).
- Is pregnant or lactating/breastfeeding at time of screening.
- 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.
Who the study is looking for
- 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.
Age in the registry: 55 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lilly Centre for Clinical Pharmacology Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.