NCT07503743 · ACTIVE NOT RECRUITING

Biology-Driven Cognitive Profiling in Huntington's Disease

This trial is studying Huntington's disease, not Alzheimer's. Researchers are using a specialized PET brain scan with a tau-detecting tracer, MRI, and cognitive tests to build better tools for spotting early brain changes in HD gene carriers before symptoms appear. It is a small pilot study — early-stage research focused on measurement and biology, not testing a treatment. Details on long-term outcomes are limited at this stage.

Eligibility criteria

Inclusion Criteria:
* Age between 18 and 75 years
* Ability to provide written informed consent approved by the Ethics Committee
* Ability to comply with study procedures, including PET imaging, MRI, cognitive testing, and blood sampling
* Participants in the Healthy Control cohort must meet the following criteria:
  1. No history of neurological or psychiatric disorders
  2. No family history of Huntington's disease
  3. Normal cognitive status based on clinical evaluation
* Participants in the Premanifest Huntington's disease gene carrier cohort must meet the following criteria:
  1. Genetically confirmed HTT CAG expansion (CAG > 38)
  2. CAP score > 250
  3. Unified Huntington's Disease Rating Scale - Total Motor Score (UHDRS-TMS) \< 4
  4. Total Functional Capacity (TFC) = 13
  5. Absence of manifest motor diagnosis (Diagnostic Confidence Level \< 4)
* Participants in the Manifest Huntington's disease cohort (early-intermediate stage) must meet the following criteria:
  1. Genetically confirmed HTT CAG expansion (CAG > 38)
  2. Diagnostic Confidence Level (DCL = 4) confirming manifest Huntington's disease
  3. CAP score > 350
  4. Total Functional Capacity (TFC) > 6
Exclusion Criteria:
* Any severe medical condition or circumstance that, in the investigator's judgment, may compromise safe participation in the study
* Current or previous participation in the RG6042 / tominersen (mHTT-lowering) clinical trial
* Participation in any interventional clinical trial within the last 12 months
* Pregnancy or breastfeeding, or intention to become pregnant during the study period
* Contraindications to PET imaging, MRI, or venous blood sampling

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2026-03-31

View full record on ClinicalTrials.gov

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