Imaging Studies in Corticobasal Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: C-11 ER176 Radiotracer, C-11 PiB, AV1451 Tau.
- Who it may be relevant to
- Registry conditions: Cortico Basal Degeneration, Corticobasal Syndrome, Corticobasal Syndrome(CBS), Corticobasal Degeneration. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Neuroinflammation, White Matter Integrity, AD Biomarkers and Pathology in Corticobasal Syndrome
Overview
The primary goal of this study is to investigate inflammation and white matter damage in corticobasal syndrome and determine whether these processes are related to each other. The investigator's will address our goal by using neuroimaging and blood plasma biomarkers, as well as molecular pathology.
Detailed description
Corticobasal syndrome (CBS) is a neurodegenerative disorder characterized by cognitive and behavioral change, as well as asymmetric parkinsonism, dystonia, myoclonus, and limb apraxia. Emerging evidence suggests neuroinflammation plays a key role in the pathogenesis of neurodegenerative disease, including the 4R tauopathies and AD, and neuroinflammation has been linked mechanistically to damage of the white matter. The primary goal of this study is to investigate inflammation and white matter damage using imaging and blood samples.
The investigator's will use the PET ligand 11C-ER176 to assess patterns of neuroinflammation in the brain and Neurite Orientation Dispersion and Density Imaging (NODDI) to measure white matter microstructure, including axonal density and alignment. The investigator's will also investigate blood plasma metrics, including neurofilament light chain and plasma glial fibrillary acidic protein (GFAP) that measure neuroaxonal injury and astrogliosis, and inflammation and tau metrics. The investigator's will employ beta-amyloid (A) and tau (T) PET to subdivide the CBS patients into those with biomarker AD (A+T+, CBS-AD) and those without biomarker AD (CBS-4R). The investigator's will also compare these groups to disease controls with typical amnestic biomarker AD (Amn-AD) and healthy controls (HC) that have previously been recruited for other grants (existing data collected under approved IRBs).
Interventions
- Diagnostic test C-11 ER176 Radiotracer
PET scan looking for inflammation - Diagnostic test C-11 PiB
PET scan looking for amyloid protein - Diagnostic test AV1451 Tau
Pet scan looking for Tau protein
Primary outcome measures
- The investigators will use C-11 ER176 PET imaging to evaluate neuroinflammation and white matter integrity in CBS [Time frame: approximately 4-5 years into study visits]
Secondary outcome measures (1)
- the investigators will use blood samples to assess inflammatory and tau blood plasma metrics in CBS. [Time frame: approximately 4-5 years into study visits]
Eligibility criteria
Inclusion criteria
- Age 18 years or older
- Meet possible or probable CBS criteria
Exclusion criteria
- Subjects will be excluded if MRI is contraindicated (due to implanted device, severe claustrophobia, etc)
- Subjects will be excluded if they have a concurrent illnesses or structural abnormality that could account for the CBS syndrome
- Subjects will be excluded if they have a mutation in the progranulin gene
- Subjects will excluded if they have received anti-Aβ therapy
- Women who are pregnant will be excluded
- Subjects will be excluded if they are actively taking daily anti-inflammatory medications (NSAIDs, corticosteriods, etc)
- Subjects will be excluded if they have generalized inflammatory condition and treatment with immunosuppressive, corticoid/glucocorticoid, steroidal or non-steroidal anti-inflammatory medication within 2 weeks of scanning
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- Mayo Clinic — Rochester
Identifiers
NCT: NCT07000851 · 24-007544 · 1R01AG087140-01A1