Clinical trial NCT07000851: Imaging Studies in Corticobasal Syndrome
Official title: Neuroinflammation, White Matter Integrity, AD Biomarkers and Pathology in Corticobasal Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cortico Basal Degeneration
Corticobasal Syndrome
Corticobasal Syndrome(CBS)
Corticobasal Degeneration
Corticobasal Degeneration (CBD)
Corticobasal Syndrome (CBS)
Keywords: neurodegeneration
neurodegenerative disease
cbs
cbd
corticobasal syndrome
corticobasal degeneration
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2025-06-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who meet criteria are eligible to participate

Brief summary: 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).

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

Primary outcomes:
measure: The investigators will use C-11 ER176 PET imaging to evaluate neuroinflammation and white matter integrity in CBS
timeFrame: approximately 4-5 years into study visits
Secondary outcomes:
measure: the investigators will use blood samples to assess inflammatory and tau blood plasma metrics in CBS.
timeFrame: approximately 4-5 years into study visits
Other outcomes:
measure: The investigators will use MR imaging to compare regional markers of inflammation, white matter integrity and tau burden in autopsy tissue from patients with CBS from two different 4R tauopathies and CBS-AD.
timeFrame: Approximately 8-10 years after study completion
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Jennifer Whitwell, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: