CompletedNot Applicable

Neural Biomarkers in Fragile X Syndrome

Spain20 participantsStarted 2024-12-16

Plain-language summary

The purpose of this non-interventional test /re-test study is to assess neural biomarkers in adult subjects with Fragile X syndrome compared to those measured in a population of typically developing adults

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Demographics common to all subjects: * Male or female subjects. * Age ≥ 18 and ≤ 55 years. * Weight ≥ 50 kg and ≤ 100 kg. * Body mass index (BMI) ≥ 18.5 and ≤ 30. Subjects with Fragile X syndrome Inclusion Criteria: * Clinical and molecular diagnosis of Fragile X syndrome (\> 200 CGG repeats in the promoter region of the FMR1 gene). * Legal representative understands and accepts the study procedures. If only one parent signs, he/she should confirm that the other parent does not object to the patient's participation in the research project. * Subject assenting and/or willing to participate. * Signed informed consent by a legal representative before any study-mandated procedure. * Subject is independently mobile and has sufficient vision and hearing to participate in study evaluations. They must be able to be understood most of the time and must not use other forms of communication, signs, symbol boards or devices as their primary form of communication. * Subjects must have a parent, or other reliable caregiver, who agrees to accompany the subject to all study visits, provide information about the subject as required by the protocol, and ensure compliance with study tests. * Subjects are expected to complete all procedures scheduled during the study visits. Subjects with Fragile X syndrome Exclusion Criteria: * Personal history of infantile spasms/convulsions/epilepsy, severe head trauma or CNS infections (e.g. meningitis), with the exception of infantile febrile seizures.…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cognitive profile of FXS patients compared to neurotypical subjects using the NIH-TCB-ID Toolbox

Timeframe: Day 1 and Day 28 (± 3 days)

Neural oscillations using Electroencephalography (EEG)

Timeframe: Day 1

Point of gaze using eye tracking

Timeframe: Day 1 and Day 28 (± 3 days)

Behavior troubles of the FXS patients compared to neurotypical subjects using the Aberrant Behavior Checklist (ABC)

Timeframe: ≤ 1 month prior to Day 1

Adaptative functioning using the Vineland Adaptive Behaviour Scale (VABS-3)

Timeframe: ≤ 1 month prior to Day 1

Clinician-rated global functioning using the Clinical Global Impression (CGI)

Timeframe: ≤ 1 month prior to Day 1 and Day 28 (± 3 days)

Stress biomarkers of the FXS patients compared to neurotypical subjects measured by cortisol concentrations in hair (occipital area)

Trial details

NCT IDNCT06957054

SponsorConnecta Therapeutics, S.L.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-03-20

View on ClinicalTrials.gov More Fragile X Syndrome (FXS) trials

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Cognitive profile of FXS patients compared to neurotypical subjects using the NIH-TCB-ID Toolbox

Timeframe: Day 1 and Day 28 (± 3 days)

Neural oscillations using Electroencephalography (EEG)

Timeframe: Day 1

Point of gaze using eye tracking

Timeframe: Day 1 and Day 28 (± 3 days)

Behavior troubles of the FXS patients compared to neurotypical subjects using the Aberrant Behavior Checklist (ABC)

Timeframe: ≤ 1 month prior to Day 1

Adaptative functioning using the Vineland Adaptive Behaviour Scale (VABS-3)

Timeframe: ≤ 1 month prior to Day 1

Clinician-rated global functioning using the Clinical Global Impression (CGI)

Timeframe: ≤ 1 month prior to Day 1 and Day 28 (± 3 days)

Stress biomarkers of the FXS patients compared to neurotypical subjects measured by cortisol concentrations in hair (occipital area)