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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age55-85
SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

  • Activity Monitor

    Device

    Device monitors physical movement.

  • 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.

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Participants with Asymptomatic or Early Alzheimer's Disease3 interventions

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: