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

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ClinicalTrials.gov Identifier: NCT04680130
Recruitment Status : Recruiting
First Posted : December 22, 2020
Last Update Posted : December 23, 2021
Sponsor:
Information provided by (Responsible Party):
Keith A. Josephs, Mayo Clinic

Study Description
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Brief Summary:
The investigators aim to learn more about symptoms suggestive of a neurodegenerative process.

Condition or disease Intervention/treatment
PSP CBD PCA LPA Semantic Dementia Semantic Aphasia Behavioral Variant of Frontotemporal Dementia FTD PPA Apraxia of Speech Drug: C-11 PiB Drug: AV1451 Tau

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, a DaTscan, a gait lab test, an ocular motor or eye movement exam and/or a swallow evaluation. At baseline only, all participants will be asked to provide a blood sample to allow for future genetic studies.
Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinico-Pathologic-Genetic-Imaging Study of Neurodegenerative and Related Disorders
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : November 1, 2050
Estimated Study Completion Date : November 1, 2050

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Symptoms of neurodegenerative disease
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 from undergoing the MRI if it 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04680130


Contacts
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Contact: Sarah Boland, CCRP 507-284-3863 boland.sarah@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Sarah Boland, CCRP    507-284-3863    boland.sarah@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Keith A. Josephs, Professor of Neurology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04680130    
Other Study ID Numbers: 19-009999
First Posted: December 22, 2020    Key Record Dates
Last Update Posted: December 23, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dementia
Aphasia
Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Apraxias
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
 Neurodegenerative Diseases
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Psychomotor Disorders