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

NCT07485153 | Not Yet Recruiting

• 2 other identifiers: 27283H7I-MC-S033
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer's Disease; Early Alzheimer's Disease; Memory Problems

Outcome Measures

Primary Outcomes (1)

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

  Night 1, Night 2

Study Arms (1)

Participants with Asymptomatic or Early Alzheimer's Disease

Mobile Electroencephalogram (EEG) with Sleep Study

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

Interventions

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.

Also known as: Somfit

Participants with Asymptomatic or Early Alzheimer's Disease

Activity Monitor DEVICE

Device monitors physical movement.

Also known as: ActiGraph LEAP Activity Monitor

Participants with Asymptomatic or Early Alzheimer's Disease

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.

Also known as: Polysomnography

Participants with Asymptomatic or Early Alzheimer's Disease

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

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 may not qualify 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

MeSH Terms

Conditions

Alzheimer Disease; Memory Disorders

Interventions

Fitness Trackers; Polysomnography

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies; Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

1-317-615-4559; LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: March 20, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 20, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)