Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391619
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-01-26
Brief Title:
Huntingtons Disease Young Adult Study 20
Sponsor:
University College London
Organization:
University College London
Study Overview
Official Title:
Huntingtons Disease Young Adult Study 20
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HD-YAS
Brief Summary:
The goal of this observational study is to learn about the first signs of disease in young adult carriers of the gene for Huntingtons disease The main questions to answer are
what are the earliest signs of the disease
can we identify the best time to intervene with treatment to prevent or delay onset of symptoms
can we identify the most reliable markers of disease for use in prevention trials
Participants will undergo the following assessments
clinical examination
cognitive and neuropsychiatric testing
brain imaging
biofluid sampling
Researchers will compare gene carriers with matched controls to see if any of these measures show evidence of early disease effects
what are the earliest signs of the disease
can we identify the best time to intervene with treatment to prevent or delay onset of symptoms
can we identify the most reliable markers of disease for use in prevention trials
Participants will undergo the following assessments
clinical examination
cognitive and neuropsychiatric testing
brain imaging
biofluid sampling
Researchers will compare gene carriers with matched controls to see if any of these measures show evidence of early disease effects
Detailed Description:
We will undertake follow up assessments of the HD-YAS cohort comprising far-from-onset premanifest mutation carriers preHD n64 and controls matched for age sex and education n67 These assessments will occur approximately 45 and 6 years after their baseline assessment They will include
detailed clinical assessment
cognitive testing using CANTAB and the EMOTICOM
neuropsychiatric assessment
neuroimaging including 3T volumetric MRI NODDI resting state fMRI and multiparametric mapping A subset of 20 gene carriers and 20 controls will undergo 7T imaging
blood and CSF sampling
We will compare change over time in preHD and control groups and model disease burden influence an early natural history proxy within the preHD group These analyses will incorporate previous baseline measurements providing three timepoints We will create a data-driven natural history of pathological changes across the pre-clinical period in HD and estimate longitudinal models of age and CAG-dependence on the outcomes providing a critical tool to increase power
detailed clinical assessment
cognitive testing using CANTAB and the EMOTICOM
neuropsychiatric assessment
neuroimaging including 3T volumetric MRI NODDI resting state fMRI and multiparametric mapping A subset of 20 gene carriers and 20 controls will undergo 7T imaging
blood and CSF sampling
We will compare change over time in preHD and control groups and model disease burden influence an early natural history proxy within the preHD group These analyses will incorporate previous baseline measurements providing three timepoints We will create a data-driven natural history of pathological changes across the pre-clinical period in HD and estimate longitudinal models of age and CAG-dependence on the outcomes providing a critical tool to increase power
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None