Cortico Basal DegenerationI-CANNCT07000851
Imaging Studies in Corticobasal Syndrome
An observational study of Cortico Basal Degeneration and Corticobasal Syndrome, run by Jennifer Whitwell at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cortico Basal Degeneration, Corticobasal Syndrome, Corticobasal Syndrome(CBS)
- What is being tested?
- C-11 ER176 Radiotracer, C-11 PiB and AV1451 Tau
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2025to 30 Mar 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients who meet criteria are eligible to participate
Who may be able to join
- Age 18 years or older
- Meet possible or probable CBS criteria
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Neuroinflammation, White Matter Integrity, AD Biomarkers and Pathology in Corticobasal Syndrome
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.
Read the 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).
- Conditions
- Cortico Basal Degeneration, Corticobasal Syndrome, Corticobasal Syndrome(CBS), Corticobasal Degeneration, Corticobasal Degeneration (CBD), Corticobasal Syndrome (CBS)
- Being tested
- C-11 ER176 Radiotracer, C-11 PiB, AV1451 Tau
- Keywords
- neurodegeneration, neurodegenerative disease, cbs, cbd, corticobasal syndrome, corticobasal degeneration
- Medical subject headings
- Corticobasal Degeneration, Nerve Degeneration, Neurodegenerative Diseases, Color Vision Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-11 ER176 RadiotracerDiagnostic test
PET scan looking for inflammation
C-11 PiBDiagnostic test
PET scan looking for amyloid protein
AV1451 TauDiagnostic test
Pet scan looking for Tau protein
| Study group | Role | What they receive |
|---|---|---|
| Corticobasal Syndrome | patients diagnosed with cbs Receives: Diagnostic Test: C-11 ER176 Radiotracer; Diagnostic Test: C-11 PiB; Diagnostic Test: AV1451 Tau | |
| Healthy Control | Healthy Control Volunteer Receives: Diagnostic Test: C-11 ER176 Radiotracer; Diagnostic Test: C-11 PiB; Diagnostic Test: AV1451 Tau |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measure whether plasma metrics differ between CBS-4R, CBS-AD, Amn-AD, and HC.
Measured: approximately 4-5 years into study visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start25 Jun 2025
- Primary completion30 Mar 2030 (estimated)
- Study completion30 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cortico Basal DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jennifer Whitwell
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor-investigator, Jennifer Whitwell, Mayo Clinic
- Investigators
- Jennifer Whitwell, Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000851
- Sponsor's protocol ID
- 24-007544
- Other IDs
- 1R01AG087140-01A1
- Acronym
- I-CAN
- Status last verified
- Jul 2026
- First submitted
- 23 May 2025
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroinflammation, White Matter Integrity, AD Biomarkers and Pathology in Corticobasal Syndrome
- ClinicalTrials.gov ID
- NCT07000851
- Acronym / sponsor ID
- I-CAN / 24-007544
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Jennifer WhitwellUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 30 Mar 2030 (estimated)
- Study completion
- 30 Mar 2031 (estimated)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corticobasal Syndrome | – | Diagnostic Test: C-11 ER176 Radiotracer, Diagnostic Test: C-11 PiB, Diagnostic Test: AV1451 Taupatients diagnosed with cbs |
| Healthy Control | – | Diagnostic Test: C-11 ER176 Radiotracer, Diagnostic Test: C-11 PiB, Diagnostic Test: AV1451 TauHealthy Control Volunteer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who meet criteria are eligible to participate
Key inclusion criteria (2 listed)
- Age 18 years or older
- Meet possible or probable CBS criteria
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-11 ER176 RadiotracerPET scan looking for inflammation | Diagnostic test | Corticobasal Syndrome, Healthy Control |
| C-11 PiBPET scan looking for amyloid protein | Diagnostic test | Corticobasal Syndrome, Healthy Control |
| AV1451 TauPet scan looking for Tau protein | Diagnostic test | Corticobasal Syndrome, Healthy Control |
Primary outcome
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
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Whitwell, Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cortico Basal Degeneration and Corticobasal Syndrome, run by Jennifer Whitwell at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan J Meyer, M.B.A. (507-293-1164, meyer.megan6@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.