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Enrolling by invitation NCT04680130

Clinico-Pathologic-Genetic-Imaging Study of Neurodegenerative and Related Disorders

Observational PSP CBD PCA LPA

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: C-11 PiB, AV1451 Tau, C-11 ER176.
Who it may be relevant to
Registry conditions: PSP, CBD, PCA, LPA. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Imaging analysis [Time frame: 1 year]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Mayo Clinic — Rochester

Identifiers

NCT: NCT04680130 · 19-009999

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗