ClinicalTrials.gg
Not yet recruitingNCT07485153Updated Mar 20, 2026

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

An observational study in Alzheimer's Disease, Early Alzheimer's Disease and Memory Problems, sponsored by Eli Lilly and Company. Not yet recruiting at 1 site in Singapore. Open to participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-03-20.

Sponsored by Eli Lilly and Company · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
35
Ages
55 Years to 85 Years
Sex
All
01

Study 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. For each participant, the study will last at least a week and will last up to three months.

02

Conditions studied

  • Alzheimer's Disease
  • Early Alzheimer's Disease
  • Memory Problems
03

In context

Alzheimer Disease

3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.

This study's planned enrollment of 35 is below the median of 200 across 814 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.

Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Singaporean age 55-85 with mild memory complaints or MCI who are otherwise healthy.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.
  • (MoCA) score of 24 or greater.
  • Clinical Dementia Rating Scale (CDR) global score of 0 or 0.5.
  • Able to provide signed .
  • 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

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 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
35 participants (estimated)
Patient registry
No

Groups and cohorts

  • Participants with Asymptomatic or Early Alzheimer's Disease

    Mobile Electroencephalogram (EEG) with Sleep Study

    Device: Mobile EEG · Device: Activity Monitor · Device: Sleep Study

Interventions

  • DeviceMobile EEG

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

    Also known as: Somfit

  • DeviceActivity Monitor

    Device monitors physical movement.

    Also known as: ActiGraph LEAP Activity Monitor

  • DeviceSleep Study

    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.

    Also known as: Polysomnography

06

What researchers measure

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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07485153
Responsible party
Sponsor
First posted
Mar 20, 2026
Start date
Mar 2026 (estimated)
Primary completion
Sep 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
Mar 20, 2026

Study contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
LillyTrials@Lilly.com
1-317-615-4559
Physicians interested in becoming principal investigators please contact
Contact
clinical_inquiry_hub@lilly.com
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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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