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

Parkinson Disease Clinical Trial

— AND1  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04680130
• Other study ID #: 19-009999
• Status: Enrolling by invitation
• Start date: November 1, 2020
• Est. completion date: November 2050

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: November 2050
• Est. primary completion date: November 2050
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aphasia
• Aphasia, Primary Progressive
• Apraxia of Speech
• Apraxias
• Behavioral Variant of Frontotemporal Dementia
• CBD
• Dementia
• Frontotemporal Dementia
• FTD
• LPA
• MSA - Multiple System Atrophy
• Multiple System Atrophy
• Parkinson Disease
• PCA
• Pick Disease of the Brain
• PPA
• PSP
• Semantic Aphasia
• Semantic Dementia
• Shy-Drager Syndrome

Intervention

Drug:
• C-11 PiB
Completing PET scan looking for amyloid protein
• AV1451 Tau
Completing PET scan looking for tau protein
• C-11 ER176
Completing PET scan looking for neuroinflammation

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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