Alzheimer's DiseaseNCT07485153
A Study to Compare Two Different Sleep Tests in Participants With No Symptoms or Early Symptoms of Alzheimer's Disease
An observational study of Alzheimer's Disease and Early Alzheimer's Disease, run by Eli Lilly and Company at 1 site in Singapore.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Alzheimer's Disease, Early Alzheimer's Disease, Memory Problems
- What is being tested?
- Mobile EEG, Activity Monitor and Sleep Study
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteSingapore
- Study dates
- Mar 2026to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Singaporean age 55-85 with mild memory complaints or MCI who are otherwise healthy.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
Singapore1 site
Lilly Centre for Clinical Pharmacology
Singapore, 138623
Jeffer Pang Hann Wei, pang_jeffer_hann_wei@lilly.com
About this study
Official 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
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.
- Being tested
- Mobile EEG, Activity Monitor, Sleep Study
- Medical subject headings
- Alzheimer Disease, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile EEGDevice
Also called Somfit
Device measures electrical activity in the brain, pulse rate, blood oxygen saturation levels, changes in blood flow and volume, motion and snoring.
Activity MonitorDevice
Also called ActiGraph LEAP Activity Monitor
Device monitors physical movement.
Sleep StudyDevice
Also called Polysomnography
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Asymptomatic or Early Alzheimer's Disease | Mobile Electroencephalogram (EEG) with Sleep Study Receives: Device: Mobile EEG; Device: Activity Monitor; Device: Sleep Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Agreement between Participants with the Same Results in Sleep Staging Using EEG and Sleep Study
Measured: Night 1, Night 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485153
- Sponsor's protocol ID
- 27283
- Other IDs
- H7I-MC-S033
- Status last verified
- Oct 2025
- First submitted
- 5 Feb 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07485153
- Acronym / sponsor ID
- 27283
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Asymptomatic or Early Alzheimer's Disease | – | Device: Mobile EEG, Device: Activity Monitor, Device: Sleep StudyMobile Electroencephalogram (EEG) with Sleep Study |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Singaporean age 55-85 with mild memory complaints or MCI who are otherwise healthy.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile EEGAlso: SomfitDevice measures electrical activity in the brain, pulse rate, blood oxygen saturation levels, changes in blood flow and volume, motion and snoring. | Device | Participants with Asymptomatic or Early Alzheimer's Disease |
| Activity MonitorAlso: ActiGraph LEAP Activity MonitorDevice monitors physical movement. | Device | Participants with Asymptomatic or Early Alzheimer's Disease |
| Sleep StudyAlso: PolysomnographyIn-Laboratory overnight assessment using EEG, electromyography to measure muscle movement, eye movement, electrical activity in the heart, blood oxygen saturation levels and breathing levels. | Device | Participants with Asymptomatic or Early Alzheimer's Disease |
Primary outcome
Percentage of Agreement between Participants with the Same Results in Sleep Staging Using EEG and Sleep Study
Time frame: Night 1, Night 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease and Early Alzheimer's Disease, run by Eli Lilly and Company at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Agreement between Participants with the Same Results in Sleep Staging Using EEG and Sleep Study (time frame: Night 1, Night 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.