ClinicalTrials.gov record NCT04680130
Clinico-Pathologic-Genetic-Imaging Study of Neurodegenerative and Related Disorders
Clinico-Pathologic-Genetic-Imaging Study of Neurodegenerative and Related Disorders
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is a prospective observational study of people with symptoms suggestive of a neurodegenerative or related disorder. Participants have a baseline evaluation and may be seen yearly for follow-up. Evaluations can include neurological, speech/language, and cognitive testing, MRI and several PET scans, and a blood sample for future genetic studies.
What it is studying. The study aims to describe and track how clinical symptoms, brain imaging findings, and genetic data relate to one another over time in people with possible neurodegenerative disease.
What the researchers hope to learn. To learn more about symptoms suggestive of neurodegenerative disease; to measure and track longitudinal brain imaging changes and their correlation with clinical progression; and to collect blood for future genetic research.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
The investigators aim to learn more about symptoms suggestive of a neurodegenerative process.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- C-11 PiB
- AV1451 Tau
- C-11 ER176
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- All participants will be over the age of 21
- Have symptoms suggestive of a neurodegenerative and/or related disorder
Exclusion criteria
- 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)
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants have a baseline visit and may be invited for yearly follow-up visits. At visits they may have a neurological exam, speech/language and neuropsychological testing, brain MRI, and one or more PET/CT scans (FDG, PiB, Tau, or C-11 ER176) as appropriate for their symptoms. All participants will be asked to give a blood sample for future genetic studies. Not every test is done for every person; procedures depend on individual symptoms and the study team's assessment.
How the study is structured. This is a prospective observational cohort study (no treatments are given). Participants undergo a baseline visit and possible annual follow-ups. Assessments may include neurological exams, speech and neuropsychological testing, MRI, several types of PET scans, and blood collection for genetic analysis.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The registry says participants are enrolled by invitation. Who decides who is invited, and how?
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on multiple system atrophy
Important dates
- Study start
- Nov 1, 2020
- Primary completion
- November 2050 (estimated)
- Study completion
- November 2050 (estimated)
- Target enrollment
- 500 participants (estimated)
- Last updated on registry
- Nov 21, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Mayo Clinic
- Principal investigator
- Keith A. Josephs, Professor of Neurology
Mayo Clinic
Participating sites (1)
- Mayo Clinic
Rochester, Minnesota, 55905 · United States
Terms used on this page · explanations by MedicalUpdates.ai
- MRI
- A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
- contraindicated
- A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- baseline
- Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
- follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
- PET/CT
- A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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