Eardream Data Collection in Colombia Supported by ADDF

Alzheimer Disease, Early Onset Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05570370
• Other study ID #: ADDF_COL
• Status: Recruiting
• Start date: August 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: October 2022
• Source: Swiss Federal Institute of Technology
• Contact: Carlos Tobon
• Phone: 219 69 00
• Email: carlos.tobonq[@]udea.edu.co
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer Disease, Early Onset

Intervention

Other:
• This is an observational study
This is an observational study

Locations

Country	Name	City	State
Colombia	Fundacion Universitaria de Antioquia	Medellín

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	Alzheimer's Drug Discovery Foundation

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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