Eardream Data Collection in Colombia Supported by ADDF

Brain Oscillations, Sleep, and Arousal in Human Cognition - COL

Data collection based on this study will allow us to collect neurophysiological and cognitive data collected from in-ear EEG recordings of the Autosomal dominant alzheimer's disease population in Colombia

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Disease, Early Onset
• Intervention / Treatment: Other: This is an observational study

Detailed Description

There is solid neurophysiological evidence indicating that abnormal brain rhythms during sleep and noradrenergic dysfunction are core components of cognitive decline and AD onset, and their related pathophysiology. Crucially, irregularities in these neurophysiological mechanisms appear to occur in an asymptomatic and pre-symptomatic stage, but their potential to identify susceptibility for triggering neurodegeneration has yet to be established.

Thus, the possibility to identify such risk biomarkers in humans will require the acquisition of large-scale data related direct or indirect measurements of these physiological signatures. A possible key source to obtain such large-scale data related to sleep and noradrenergic function is the assessment of electroencephalographic recordings through non-obtrusive, low-cost, and reliable wearable sensors, alongside the use of advanced neuro-computational algorithms that link brain function and behavioral outcomes of LC function via pupilometry measurements.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Carlos Tobon; Phone Number: 219 69 00; Email: carlos.tobonq@udea.edu.co
• Study Contact Backup: Name: Rafael Polania; Phone Number: +41446339975; Email: rafael.polania@hest.ethz.ch

Study Locations

• Colombia
  • Medellín, Colombia
    • Recruiting
    • Fundacion Universitaria de Antioquia
    • Contact: Carlos Tobon, MD; Phone Number: 219 69 00; Email: carlos.tobonq@udea.edu.co
    • Contact: Francisco Lopera, MD; Phone Number: 219 69 00; Email: francisco.lopera@gna.org.co

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Mutation and non-mutation carriers of ADAD populations Patients diagnosed with MCI and AD

Description

Participants fulfilling all of the following inclusion criteria are eligible for the study:

Informed Consent as documented by signature mutation and non-mutation carriers of ADAD populations Patients diagnosed with MCI and AD

Diseases or lesions of the nervous system (acute or residual included neurological and psychiatric diseases, except for MCI and AD in the patient population) Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) Sleep disorders, known or suspected (e.g. Insomnia, sleep apnoea, restless leg syndrome, narcolepsy, etc.) mini mental state examination (MMSE) score > 24)

Participants are not eligible if they fulfill the following exclusion criteria:

Participation in another study with investigational drug/therapy/interventions within the 30 days preceding and during the present study (start date adapted accordingly) Suspected drug- or medication abuse, or on-label sleep medication use during the time of the study Infection/disease of the auditory canal or ear drum that could worsen with EAR-DREAM application, or allergies to in-Ear electrode materials (e.g., silver) Pregnancy (not safety related, but relevant for data interpretation procedures given that pregnancy can result in sleep patterns that are different from the baseline measurements we intend to characterize) Additional non-medical exclusion criteria may be defined for certain cognitive tasks (e.g. no glasses during experiments involving pupillometry).

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ADAD family members, mutation carriers; asymptomatic and presymptomatic individuals	Other: This is an observational study; This is an observational study
ADAD family members, non-mutation carriers; age-matched family members (non-mutation carriers) relative to the asymptomatic/presymptomatic group	Other: This is an observational study; This is an observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Density of slow-wave activity (SWA) readout from in-ear EEG recordings	in-ear EEG will be monitored during 7 nights, the aggregated density of SWA over the 7 nights will be compared in both groups (mutation vs non-mutation carrier)	Up to 7 nights of at-home recordings
Relative phasic pupilometry responses in exploration vs exploration states in the cognitive task	atent variables of the LC-noradrenergic neuro-computational model based on our cognitive task will indicate the state in wich the participant is (exploration vs exploitation). The relative phasic pupilometry responses in these two states will serve as a proxy of the degree of LC-noradrenergic reaction to these states. The relative reactivity will be compared in both groups (mutation vs non-mutation carriers)	experimental session at day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative time-frequency decomposition responses in exploration vs exploration states in the cognitive task measured with EEG	We will evaluate the the differences spatio-temporal changes in the power spectrum depending on the state in wich the participant is (exploration vs exploitation) in the cognitive task. The relative changes will be compared in both groups (mutation vs non-mutation carriers)	experimental session at day 1

Collaborators and Investigators

• Sponsor: Swiss Federal Institute of Technology
• Collaborators: Alzheimer's Drug Discovery Foundation

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: October 5, 2022
• First Posted (Actual): October 6, 2022

Study Record Updates

• Last Update Posted (Actual): October 6, 2022
• Last Update Submitted That Met QC Criteria: October 5, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: ADDF_COL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No