Alzheimer Disease, Early OnsetNCT05570370
Eardream Data Collection in Colombia Supported by ADDF
An observational study of Alzheimer Disease, Early Onset, run by Swiss Federal Institute of Technology at 1 site in Colombia.
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 Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Alzheimer Disease, Early Onset
- What is being tested?
- This is an observational study
- How many people
- 120 participants
- Where
- 1 siteColombia
- Study dates
- 1 Aug 2022to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Adult, Older adult
Study population: Mutation and non-mutation carriers of ADAD populations Patients diagnosed with MCI and AD
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).
Trial locations and contacts
1 site in 1 country.
Colombia1 site, 1 recruiting
- Recruiting
Fundacion Universitaria de Antioquia
Medellín
Carlos Tobon, MD, 219 69 00, carlos.tobonq@udea.edu.co
Francisco Lopera, MD, 219 69 00, francisco.lopera@gna.org.co
About this study
Official title: 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
Read the 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.
- Conditions
- Alzheimer Disease, Early Onset
- Being tested
- This is an observational study
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is an observational studyOther
This is an observational study
| Study group | Role | What they receive |
|---|---|---|
| ADAD family members, mutation carriers | asymptomatic and presymptomatic individuals Receives: 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 Receives: Other: This is an observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
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)
Measured: experimental session at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start1 Aug 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease, Early OnsetStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Drug Discovery Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570370
- Sponsor's protocol ID
- ADDF_COL
- Status last verified
- Oct 2022
- First submitted
- 11 May 2022
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Oscillations, Sleep, and Arousal in Human Cognition - COL
- ClinicalTrials.gov ID
- NCT05570370
- Acronym / sponsor ID
- ADDF_COL
- Conditions
- Alzheimer Disease, Early Onset
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Alzheimer's Drug Discovery Foundation
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADAD family members, mutation carriers | – | Other: This is an observational studyasymptomatic and presymptomatic individuals |
| ADAD family members, non-mutation carriers | – | Other: This is an observational studyage-matched family members (non-mutation carriers) relative to the asymptomatic/presymptomatic group |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Mutation and non-mutation carriers of ADAD populations Patients diagnosed with MCI and AD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is an observational studyThis is an observational study | Other | ADAD family members, mutation carriers, ADAD family members, non-mutation carriers |
Primary outcome
Density of slow-wave activity (SWA) readout from in-ear EEG recordings
Time frame: Up to 7 nights of at-home 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)
Relative phasic pupilometry responses in exploration vs exploration states in the cognitive task
Time frame: experimental session at day 1
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)
1 secondary outcome
Relative time-frequency decomposition responses in exploration vs exploration states in the cognitive task measured with EEG
Time frame: experimental session at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, Early Onset, run by Swiss Federal Institute of Technology at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos Tobon (219 69 00, carlos.tobonq@udea.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Density of slow-wave activity (SWA) readout from in-ear EEG recordings (time frame: Up to 7 nights of at-home recordings). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2022.