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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04680130
Other study ID # 19-009999
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
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
Health authority
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)

Study Design


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
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