PSPAND1NCT04680130
Clinico-Pathologic-Genetic-Imaging Study of Neurodegenerative and Related Disorders
An observational study of PSP and CBD, run by Mayo Clinic at 1 site in United States.
Trial summary
The investigators aim to learn more about symptoms suggestive of a neurodegenerative process. Read more about this study
- Who is it for?
- Ages 21 years and older
- What is being tested?
- C-11 PiB, AV1451 Tau and C-11 ER176
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2020to Nov 2050
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Symptoms of neurodegenerative disease
Who may be able to join
- All participants will be over the age of 21
- Have symptoms suggestive of a neurodegenerative and/or related disorder
Who cannot join
- Participants will be excluded if they have any concurrent illnesses that could account for all of their symptoms, such as traumatic brain injury, encephalitis, strokes or developmental syndromes
- Women that are pregnant or post-partum and breast-feeding will be excluded
- Participants will be excluded if they have any of the following genetic conditions which can increase the chance of cancer: Cowden disease, Lynch syndrome, Hypogammaglobulinemia, Wiskott-Aldrich syndrome and Down's syndrome
- Participants will be excluded if MRI is contraindicated (metal in head, cardiac pace maker, etc), if there is severe claustrophobia, if there are conditions that may confound brain imaging studies (e.g. structural abnormalities, including subdural hematoma, intracranial neoplasm or large cortical infarcts)
- Participants will be excluded if they are medically unstable or are on medications that might affect brain structure or metabolism (e.g. chemotherapy)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The investigators aim to learn more about symptoms suggestive of a neurodegenerative process.
Read the detailed description
The investigators will recruit participants with symptoms suggestive of a neurodegenerative and/or related disease. Participants could be evaluated on a yearly basis, undergoing a baseline visit and possible follow-up evaluations with an interval of one year. At each visit, participants could undergo any combination of the following based on their symptoms and complaints: a neurological assessment, a speech/language assessment, a neuropsychometric assessment, an MRI, an FDG PET/CT scan, a PiB PET/CT scan, a Tau PET/CT scan and/or a C-11 ER176 PET/CT scan. All participants will be asked to provide a blood sample to allow for future genetic studies.
- Conditions
- PSP, CBD, PCA, LPA, Semantic Dementia, Semantic Aphasia
- Being tested
- C-11 PiB, AV1451 Tau, C-11 ER176
- Medical subject headings
- Frontotemporal Dementia, Aphasia, Pick Disease of the Brain, Apraxias, Shy-Drager Syndrome, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-11 PiBDrug
Completing PET scan looking for amyloid protein
AV1451 TauDrug
Completing PET scan looking for tau protein
C-11 ER176Drug
Completing PET scan looking for neuroinflammation
| Study group | Role | What they receive |
|---|---|---|
| Neurodegenerative symptoms | Not described Receives: Drug: C-11 PiB; Drug: AV1451 Tau; Drug: C-11 ER176 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging analysis
Longitudinal images and correlates will be measured and tracked to determine direct correlations in the brain with disease progression on a yearly basis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start1 Nov 2020
- Primary completionNov 2050 (estimated)
- Study completionNov 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PSPStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keith A. Josephs, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680130
- Sponsor's protocol ID
- 19-009999
- Acronym
- AND1
- Status last verified
- Nov 2025
- First submitted
- 3 Nov 2020
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinico-Pathologic-Genetic-Imaging Study of Neurodegenerative and Related Disorders
- ClinicalTrials.gov ID
- NCT04680130
- Acronym / sponsor ID
- AND1 / 19-009999
- Conditions
- PSP, CBD, PCA, LPA, Semantic Dementia, Semantic Aphasia
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- Nov 2050 (estimated)
- Study completion
- Nov 2050 (estimated)
- First posted
- 22 Dec 2020 (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 investigators aim to learn more about symptoms suggestive of a neurodegenerative process.
Detailed description
The investigators will recruit participants with symptoms suggestive of a neurodegenerative and/or related disease. Participants could be evaluated on a yearly basis, undergoing a baseline visit and possible follow-up evaluations with an interval of one year. At each visit, participants could undergo any combination of the following based on their symptoms and complaints: a neurological assessment, a speech/language assessment, a neuropsychometric assessment, an MRI, an FDG PET/CT scan, a PiB PET/CT scan, a Tau PET/CT scan and/or a C-11 ER176 PET/CT scan. All participants will be asked to provide a blood sample to allow for future genetic studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurodegenerative symptoms | – | Drug: C-11 PiB, Drug: AV1451 Tau, Drug: C-11 ER176 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Symptoms of neurodegenerative disease
Key inclusion criteria (2 listed)
- All participants will be over the age of 21
- Have symptoms suggestive of a neurodegenerative and/or related disorder
Key exclusion criteria (5 listed)
- Participants will be excluded if they have any concurrent illnesses that could account for all of their symptoms, such as traumatic brain injury, encephalitis, strokes or developmental syndromes
- Women that are pregnant or post-partum and breast-feeding will be excluded
- Participants will be excluded if they have any of the following genetic conditions which can increase the chance of cancer: Cowden disease, Lynch syndrome, Hypogammaglobulinemia, Wiskott-Aldrich syndrome and Down's syndrome
- Participants will be excluded if MRI is contraindicated (metal in head, cardiac pace maker, etc), if there is severe claustrophobia, if there are conditions that may confound brain imaging studies (e.g. structural abnormalities, including subdural hematoma, intracranial neoplasm or large cortical infarcts)
- Participants will be excluded if they are medically unstable or are on medications that might affect brain structure or metabolism (e.g. chemotherapy)
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 PiBCompleting PET scan looking for amyloid protein | Drug | Neurodegenerative symptoms |
| AV1451 TauCompleting PET scan looking for tau protein | Drug | Neurodegenerative symptoms |
| C-11 ER176Completing PET scan looking for neuroinflammation | Drug | Neurodegenerative symptoms |
Primary outcome
Imaging analysis
Time frame: 1 year
Longitudinal images and correlates will be measured and tracked to determine direct correlations in the brain with disease progression on a yearly basis
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 21 Nov 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for PSP
RecruitingPhase 2
The Progressive Supranuclear Palsy Clinical Trial Platform
Progressive Supranuclear Palsy(PSP)
RecruitingPhase 3
A Study to Evaluate the Efficacy of NIO752 in Participants With Progressive Supranuclear Palsy
Progressive Supranuclear Palsy Richardson Syndrome (PSP-RS)
Not yet recruitingObservational study
Digital Health Technologies for Progressive Supranuclear Palsy and Dementia With Lewy Bodies
Progressive Supranuclear Palsy(PSP), Dementia With Lewy Bodies (DLB)
RecruitingObservational study
ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD)
Frontotemporal Lobar Degeneration (FTLD), Progressive Supranuclear Palsy (PSP)
RecruitingPhase 1/2
Tributyrin for Progressive Supranuclear Palsy (PSP): Virtual Trial
Parkinson Disease, Multiple System Atrophy
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.
The record lists no contact. Use the official record to reach the sponsor.
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 PSP and CBD, run by Mayo Clinic 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 5 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: enrolling by invitation, as of the sponsor's last update on 21 Nov 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imaging analysis (time frame: 1 year). 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 21 Nov 2025; AzTrials last refreshed its copy on 26 Oct 2026.