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

NCT04680130 | Enrolling By Invitation FDA Drug

• 1 other identifier: 19-009999
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

PSP; CBD; PCA; LPA; Semantic Dementia; Semantic Aphasia; Behavioral Variant of Frontotemporal Dementia; FTD; PPA; Apraxia of Speech; MSA - Multiple System Atrophy; Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Imaging analysis

  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

Study Arms (1)

Neurodegenerative symptoms

Drug: C-11 PiB; Drug: AV1451 Tau; Drug: C-11 ER176

Interventions

C-11 PiB DRUG

Completing PET scan looking for amyloid protein

Neurodegenerative symptoms

AV1451 Tau DRUG

Completing PET scan looking for tau protein

Neurodegenerative symptoms

C-11 ER176 DRUG

Completing PET scan looking for neuroinflammation

Neurodegenerative symptoms

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Symptoms of neurodegenerative disease

You may qualify if:

• All participants will be over the age of 21
• Have symptoms suggestive of a neurodegenerative and/or related disorder

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Frontotemporal Dementia; Aphasia; Pick Disease of the Brain; Apraxias; Shy-Drager Syndrome; Parkinson Disease

Interventions

2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole

Condition Hierarchy (Ancestors)

Frontotemporal Lobar Degeneration; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; TDP-43 Proteinopathies; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurocognitive Disorders; Mental Disorders; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Psychomotor Disorders; Multiple System Atrophy; Primary Dysautonomias; Autonomic Nervous System Diseases; Basal Ganglia Diseases; Movement Disorders; Hypotension; Vascular Diseases; Cardiovascular Diseases; Parkinsonian Disorders; Synucleinopathies

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: December 22, 2020
• Study Start: November 1, 2020
• Primary Completion (Estimated): November 1, 2050
• Study Completion (Estimated): November 1, 2050
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

US (1)