Clinico-Pathologic-Genetic-Imaging Study of Neurodegenerative and Related Disorders (AND1)

November 19, 2025 updated by: Keith A. Josephs, Mayo Clinic
The investigators aim to learn more about symptoms suggestive of a neurodegenerative process.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Symptoms of neurodegenerative disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Neurodegenerative symptoms
Drug: C-11 PiB
Completing PET scan looking for amyloid protein
Drug: AV1451 Tau
Completing PET scan looking for tau protein
Drug: C-11 ER176
Completing PET scan looking for neuroinflammation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Estimated)

November 1, 2050

Study Completion (Estimated)

November 1, 2050

Study Registration Dates

First Submitted

November 3, 2020

First Submitted That Met QC Criteria

December 21, 2020

First Posted (Actual)

December 22, 2020

Study Record Updates

Last Update Posted (Estimated)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-009999

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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