New brain scans aim to catch Huntington's cognitive decline early
NCT ID NCT07503743
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aims to create more sensitive cognitive tests for Huntington's disease by combining brain imaging (PET and MRI) with blood markers. Researchers will study 90 participants—healthy controls, pre-symptomatic gene carriers, and early-stage patients—to understand how brain changes relate to thinking skills. The goal is to detect subtle cognitive problems earlier and better classify different types of cognitive decline, which could help future treatment trials.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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90 people
The number who actually took part.
- Started
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Sep 2021
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
This study will enroll a total of 90 participants distributed across three cohorts: healthy controls, premanifest Huntington's disease (HD) gene carriers, and individuals with early-to-intermediate manifest HD. Healthy controls will be adults with no neurological or psychiatric disorders and no family history of HD. Premanifest participants will be genetically confirmed HTT mutation carriers who do not yet meet diagnostic criteria for motor-manifest HD but show biological vulnerability to neurodegeneration. Manifest participants will include individuals with clinically diagnosed HD in the early or intermediate stages, characterized by a Diagnostic Confidence Level of 4 and preserved functional capacity. All participants must be able to undergo PET imaging, MRI, cognitive testing, and blood sampling. The study population is designed to capture the full early spectrum of HD-related change-from normal aging to premanifest pathology to clinically manifest disease-to enable biomarker-based
- Ages
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30 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hospital de la Sant aCreu i Sant Pau
Barcelona, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.