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

Sponsor

Mayo Clinic (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04680130

Collaborator

(none)

500

Enrollment

Location

360

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators aim to learn more about symptoms suggestive of a neurodegenerative process.

Condition or Disease	Intervention/Treatment	Phase
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

Study Type:

Observational

Anticipated 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 :

Nov 1, 2020

Anticipated Primary Completion Date :

Nov 1, 2050

Anticipated Study Completion Date :

Nov 1, 2050

Arms and Interventions

Arm	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

Arm

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

Primary Outcome Measures

Imaging analysis [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

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)