Actively Recruiting
Innovative Imaging and Cognitive BIOmarkers to Predict Huntington's Disease Progression
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-05-07
80
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Intro Huntington's disease (HD) patients suffer from motor, cognitive and behavioral impairments, with heterogeneous phenotypes and variable time course. This leads to a high variance of HD markers, none of which is currently sensitive enough to 1) measure disease progression from small cohort data, 2) predict disease entry in carriers of the HD mutation (during the prodromal phase or in patients considered asymptomatic: pre-HD patients), and 3) measure a significant evolution of the state of pre-HD patients over a time window compatible with the realization of clinical trials (about 2/3 years). Moreover, the markers of HD do not allow a fine stratification of the patients. Hypothesis/Objective Our objectives are 1) to evaluate the sensitivity of new markers and assessment tools for symptomatic (HD) and presymptomatic (pre-HD) patients, 2) to define a model of disease progression, and 3) to establish an enrichment strategy to improve patient selection for future therapeutic trials. Method We will evaluate newly developed cognitive tests, multimodal imaging techniques, biological markers and use innovative statistical approaches. We will follow 60 patients with the mutation responsible for MH (40 presymptomatic pre-MH patients, 20 symptomatic MH patients) and 20 healthy volunteers (controls) over a 24-month period.
CONDITIONS
Official Title
Innovative Imaging and Cognitive BIOmarkers to Predict Huntington's Disease Progression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years to 65 years
- Written informed consent provided
- Affiliation with a social security plan or beneficiary rights
- Healthy controls: UHDRS functional score (TFC) = 13, Motor UHDRS score (TMS) < 6, no known genetic disease or direct relation to HD mutation carriers
- Manifest carriers: GAC repeats ≥ 40, CAP score ≥ 250, TFC between 10 and 13, TMS > 5 if TFC = 13, diagnostic confidence level = 4, age of disease onset > 20 years, physically able to sign consent
- Premanifest carriers: GAC repeats ≥ 40, CAP score ≥ 250, TFC = 13, TMS < 6, physically able to sign consent
You will not qualify if you...
- Under guardianship or curatorship
- Neurological or psychiatric disorders unrelated to Huntington's disease
- Intercurrent illness that may affect performance
- Chronic progressive neurological disease
- Claustrophobia
- Brain injury unrelated to Huntington's disease
- Presence of pacemaker, intracorporeal metal, intracerebral clips, implantable cardiac devices, metallic intraocular foreign bodies, neurostimulation systems, cochlear or ear implants, drug infusion pumps, chemotherapy pumps, or catheters with metal components
- Metal fragments such as bullets, pellets, or shrapnel
- Cerebral artery aneurysm clips, magnetic dental implants, tissue expanders, artificial limbs, hearing aids, or pacemaker piercings
- Known hypersensitivity to radiopharmaceutical preparations
- Pregnant or breastfeeding women
- Persons under state medical aid or deprived of liberty
- Participation in an interventional study within the last 3 months or in neural transplant/gene therapy trials without time limit
- Participation in research with radiopharmaceutical injection within the last 12 months
- Desire to procreate during study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hopital Henri MONDOR
Créteil, Île-de-France Region, France, 94000
Actively Recruiting
Research Team
A
Anne-Catherine BACHOUD-LEVI, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
2
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