Eardream Data Collection in Colombia Supported by ADDF

NCT ID: NCT05570370

Last Updated: 2022-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer Disease, Early Onset

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ADAD family members, mutation carriers

asymptomatic and presymptomatic individuals

This is an observational study

Intervention Type 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

This is an observational study

Intervention Type OTHER

This is an observational study

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

This is an observational study

This is an observational study

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alzheimer's Drug Discovery Foundation

OTHER

Sponsor Role collaborator

Swiss Federal Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fundacion Universitaria de Antioquia

MedellĂ­n, , Colombia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Colombia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Carlos Tobon

Role: CONTACT

219 69 00

Rafael Polania

Role: CONTACT

+41446339975

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Carlos Tobon, MD

Role: primary

219 69 00

Francisco Lopera, MD

Role: backup

219 69 00

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ADDF_COL

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Brain&Senses Study
NCT06991816 NOT_YET_RECRUITING