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 range18 Years – 55 Years

SexALL

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.…

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)

Timeframe: ≤ 1 month prior to Day 1

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 range18 Years – 55 Years

SexALL

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)

Timeframe: ≤ 1 month prior to Day 1