Imaging Studies in Corticobasal Syndrome

NCT ID: NCT07000851

Last Updated: 2025-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-25

Study Completion Date

2031-03-30

Brief Summary

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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

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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).

Conditions

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Cortico Basal Degeneration Corticobasal Syndrome Corticobasal Syndrome(CBS) Corticobasal Degeneration Corticobasal Degeneration (CBD) Corticobasal Syndrome (CBS)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Corticobasal Syndrome

patients diagnosed with cbs

C-11 ER176 Radiotracer

Intervention Type DIAGNOSTIC_TEST

PET scan looking for inflammation

C-11 PiB

Intervention Type DIAGNOSTIC_TEST

PET scan looking for amyloid protein

AV1451 Tau

Intervention Type DIAGNOSTIC_TEST

Pet scan looking for Tau protein

Healthy Control

Healthy Control Volunteer

C-11 ER176 Radiotracer

Intervention Type DIAGNOSTIC_TEST

PET scan looking for inflammation

C-11 PiB

Intervention Type DIAGNOSTIC_TEST

PET scan looking for amyloid protein

AV1451 Tau

Intervention Type DIAGNOSTIC_TEST

Pet scan looking for Tau protein

Interventions

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C-11 ER176 Radiotracer

PET scan looking for inflammation

Intervention Type DIAGNOSTIC_TEST

C-11 PiB

PET scan looking for amyloid protein

Intervention Type DIAGNOSTIC_TEST

AV1451 Tau

Pet scan looking for Tau protein

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Jennifer Whitwell

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Whitwell

Associate Consultant II

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jennifer Whitwell, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Megan J Meyer, M.B.A.

Role: CONTACT

507-293-1164

Sarah M Boland, CCRP

Role: CONTACT

507284-3863

Other Identifiers

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1R01AG087140-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-007544

Identifier Type: -

Identifier Source: org_study_id

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