Evaluation of [18F]MNI-777 PET as a Marker of Tau Pathology in Subjects With Tauopathies Compared to Healthy Subjects
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|ClinicalTrials.gov Identifier: NCT02103894|
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : December 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease (AD) Parkinson's Disease (PD) Chronic Traumatic Encephalopathy (CTE) Progressive Supranuclear Palsy (PSP) Frontal Temporal Dementia (FTD) Pick's Disease Tauopathies||Drug: [18F]T807 ([18F]MNI-777)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of [18F]MNI-777 PET as a Marker of Tau Pathology in Subjects With Clinically Diagnosed Tauopathies in Comparison to Healthy Subjects|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||September 2016|
Experimental: [18F]T807 ([18F]MNI-777)
At the [18F]MNI-777 PET imaging visit, subjects will be injected with no more than 10 mCi (370 MBq) of [18F]MNI-777).
Drug: [18F]T807 ([18F]MNI-777)
All enrolled subjects will undergo an [18F]MNI-777 PET imaging visit. For individuals with AD or CTE, [18F]florbetapir imaging may also be performed to serve as a means of correlating disease severity by evaluating the relationship of β-amyloid uptake (measured by [18F]florbetapir imaging) and tau protein uptake (measured by [18F]MNI-777 PET imaging). For individuals with Parkinsonian symptoms, [123I]β-CIT SPECT imaging may be performed to evaluate for a reduction in dopamine transporter uptake.
- Brain uptake of [18F]T807 ([18F]MNI-777) [ Time Frame: 2 years ]To quantitatively assess the brain uptake of [18F]MNI-777 ([18F]T807), an imaging biomarker for tau pathology in brain, using positron emission tomography (PET) in individuals with clinically diagnosed tauopathies including: Alzheimer's disease (AD), Parkinson's disease (PD), progressive supranuclear palsy (PSP), chronic traumatic encephalopathy (CTE) and frontal temporal dementia/Pick's disease (FTD) and healthy controls (HC).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02103894
|United States, Connecticut|
|Molecular NeuroImaging, LLC|
|New Haven, Connecticut, United States, 06510|
|Principal Investigator:||Danna Jennings, MD||Institute for Neurodegenerative Disorders|