Eardream Data Collection in Colombia Supported by ADDF

NCT05570370 | Unknown

• 1 other identifier: ADDF_COL
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Alzheimer Disease, Early Onset

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Relative time-frequency decomposition responses in exploration vs exploration states in the cognitive task measured with EEG

  experimental session at day 1

Study Arms (2)

ADAD family members, mutation carriers

asymptomatic and presymptomatic individuals

Other: 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

Interventions

This is an observational study OTHER

This is an observational study

ADAD family members, mutation carriers; ADAD family members, non-mutation carriers

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• Alzheimer's Drug Discovery Foundation: collaborator

Study Sites (1)

Fundacion Universitaria de Antioquia

Medellín, Colombia

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Carlos Tobon

CONTACT

219 69 00; carlos.tobonq@udea.edu.co

Rafael Polania

CONTACT

+41446339975; rafael.polania@hest.ethz.ch

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: October 6, 2022
• Study Start: August 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 6, 2022

Record last verified: 2022-10

Locations

CO (1)