Imaging Studies in Corticobasal Syndrome

NCT07000851 | Recruiting DMC FDA Drug

• 2 other identifiers: 24-0075441R01AG087140-01A1
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• The investigators will use C-11 ER176 PET imaging to evaluate neuroinflammation and white matter integrity in CBS

  Measure whether regional patterns of ER176-PET uptake and white matter microstructure abnormalities using NODDI differ between CBS-4R, CBS-AD, Amn-AD, and HC.

  approximately 4-5 years into study visits

Secondary Outcomes (1)

• the investigators will use blood samples to assess inflammatory and tau blood plasma metrics in CBS.

  approximately 4-5 years into study visits

Other Outcomes (1)

• 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.

  Approximately 8-10 years after study completion

Study Arms (2)

Corticobasal Syndrome

patients diagnosed with cbs

Diagnostic Test: C-11 ER176 Radiotracer; Diagnostic Test: C-11 PiB; Diagnostic Test: AV1451 Tau

Healthy Control

Healthy Control Volunteer

Diagnostic Test: C-11 ER176 Radiotracer; Diagnostic Test: C-11 PiB; Diagnostic Test: AV1451 Tau

Interventions

C-11 ER176 Radiotracer DIAGNOSTIC_TEST

PET scan looking for inflammation

Corticobasal Syndrome; Healthy Control

C-11 PiB DIAGNOSTIC_TEST

PET scan looking for amyloid protein

Corticobasal Syndrome; Healthy Control

AV1451 Tau DIAGNOSTIC_TEST

Pet scan looking for Tau protein

Corticobasal Syndrome; Healthy Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who meet criteria are eligible to participate

You may qualify if:

• Age 18 years or older
• Meet possible or probable CBS criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• Jennifer Whitwell: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Corticobasal Degeneration; Nerve Degeneration; Neurodegenerative Diseases; Color Vision Defects

Condition Hierarchy (Ancestors)

Tauopathies; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Cone Dystrophy; Eye Diseases, Hereditary; Eye Diseases; Signs and Symptoms

Study Officials

• Jennifer Whitwell, Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan J Meyer, M.B.A.

CONTACT

507-293-1164; meyer.megan6@mayo.edu

Sarah M Boland, CCRP

CONTACT

507284-3863; boland.sarah@mayo.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Consultant II

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 3, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): March 30, 2030
• Study Completion (Estimated): March 30, 2031
• Last Updated: July 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)