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

• Conditions: Semantic Aphasia; PPA; PSP; LPA; Semantic Dementia; CBD; Parkinson Disease; PCA; Behavioral Variant of Frontotemporal Dementia; FTD
• Interventions: Drug: C-11 PiB; Drug: AV1451 Tau; Drug: C-11 ER176

• Registration Number: NCT04680130
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Study Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2020-11-03
• Study First Submitted QC: 2020-12-21
• Study First Posted: 2020-12-22
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-08
• Primary Completion: 2050-11
• Study Completion: 2050-11

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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

Read More

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)

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neurodegenerative symptoms	C-11 ER176	-
Neurodegenerative symptoms	C-11 PiB	-
Neurodegenerative symptoms	AV1451 Tau	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States