BridgeMD
New treatment option for Huntington Disease
Official title Comparison Between [11C]UCB-J and [18F]SynVest-1 PET in HD.
ClinicalTrials.gov ID: NCT05360082
What this study is testing
- What it's testing
- Positron Emission Tomography (PET) is a functional imaging technique, which enables in vivo visualization of biological molecules expressed in human tissues. Brain PET is most powerful to study a vast range of neurological and psychiatric disorders in vivo, targeting neuronal and glial activity, metabolism, cerebral blood flow, receptor proteins or misfolded proteins.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 75. Healthy volunteers may be eligible.
You may be able to join if
- Healthy controls (n = 10-20)
- Subject is judged to be in good health by the investigator on the basis of medical history, physical examination including vital signs, clinical...
- No history or evidence of current major neurological, internal or psychiatric disorder, based on the medical assessment as described hereabove and...
- In people \ = 60 years of age white matter hyperintensities corresponding to a white matter lesion (WML) Fazekas score \< 2 on the Age-Related White...
- HD-ISS stage 3 HD mutation carriers (n = 10)
You likely can't join if
- Neuropsychiatric diseases; for HD mutation carriers any neuropsychiatric diseases other than HD
- Major internal medical diseases
- White matter lesion load on FLAIR Fazekas score 2 or higher or other relevant MRI abnormalities
- History of alcohol abuse or current alcohol abuse (chronic use of more than 15 units per week) or drug use
- Contraindications for MR
- Subject suffers from claustrophobia or cannot tolerate confinement during PET-MRI scanning procedures; subject cannot lie still for 30 minutes inside...
See the full eligibility criteria
- Healthy controls (n = 10-20)
- Subject is judged to be in good health by the investigator on the basis of medical history, physical examination including vital signs, clinical laboratory test and urinalysis.
- No history or evidence of current major neurological, internal or psychiatric disorder, based on the medical assessment as described hereabove and neuropsychological assessment.
- In people \ = 60 years of age white matter hyperintensities corresponding to a white matter lesion (WML) Fazekas score \< 2 on the Age-Related White Matter changes scale are acceptable.
- HD-ISS stage 3 HD mutation carriers (n = 10)
- HTT CAG repeat expansion 40 - 50
- stage 3 as determined by the HD-ISS staging criteria
- UHDRS TFC \>/= 10
- HD-ISS stage 2 HD mutation carriers (n = 10)
- HTT CAG repeat expansion 40 - 50
- stage 2 as determined by the HD-ISS staging criteria
- PIN score 0.47 - 1.84
- Neuropsychiatric diseases; for HD mutation carriers any neuropsychiatric diseases other than HD
- Major internal medical diseases
- White matter lesion load on FLAIR Fazekas score 2 or higher or other relevant MRI abnormalities
- History of alcohol abuse or current alcohol abuse (chronic use of more than 15 units per week) or drug use
- Contraindications for MR
- Subject suffers from claustrophobia or cannot tolerate confinement during PET-MRI scanning procedures; subject cannot lie still for 30 minutes inside the scanner.
- Subject is unwilling to avoid unusual, unaccustomed, or strenuous physical activity (i.e., weightlifting, running, bicycling) from the time of the pre-study visit until the end of scanning.
- Subject does not understand the study procedures or does not have a guardian who understands the study procedures.
- Subject (or guardian) is unwilling or unable to perform all of the study procedures or is considered unsuitable in any way by the principal investigator.
- Subject is on anticoagulant therapy.
- Subject is pregnant (according to Ulti Med hCG urine test) or breastfeeding.
- Subject is a woman of childbearing potential who does not agree to apply appropriate contraception methods during study participation and continues to do so for at least 6 months after study completion.
- Subject is a man with a pregnant or non-pregnant WOCBP partner, who does not agree to use a condom and continue to do so until 90 days after study completion. In addition, the non-pregnant WOCBP partner should use a...
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Belgium
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.