Evaluation of [18F]MNI-777 PET as a Marker of Tau Pathology in Subjects With Tauopathies Compared… (NCT02103894) | Clinical Trial Compass
CompletedPhase 1
Evaluation of [18F]MNI-777 PET as a Marker of Tau Pathology in Subjects With Tauopathies Compared to Healthy Subjects
United States16 participantsStarted 2014-02
Plain-language summary
The goal of this study is to assess \[18F\]MNI-777 PET imaging as a tool to detect tau pathology in the brain of individuals who carry a clinical diagnosis of a tauopathy, including: Alzheimer's Disease (AD),Parkinson's disease (PD) Progressive Supranuclear Palsy (PSP), chronic traumatic encephalopathy (CTE) and Frontal Temporal Dementia (FTD) and age- and gender-matched healthy subjects.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion Criteria:
For all subjects:
* Written informed consent or assent is obtained.
* Willing and able to cooperate with study procedures.
* For females, non-child bearing potential or negative urine pregnancy test on day of \[18F\]MNI-777 injection.
Alzheimer Disease subjects:
* The participant is 50 years or older.
* Participants have a clinical diagnosis of Alzheimer's disease based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria (McKann, 1984)
* Modified Hachinski Ischemia Scale score of ≤ 4.
Parkinson's Disease subjects:
* The participant is 30 years or older.
* Participants have a clinical diagnosis of PD based on the UK Brain Bank Criteria (Hughes, et al., 1982).
* The duration of diagnosis of PD is \<20 years prior to the imaging visit
* PD subjects must be on stable doses of medications for a period of at least 30 days prior to the imaging visit.
* Treatment with dopamine replacement therapies or other symptomatic therapies for PD is permitted; however, subjects must be on a stable dose of medications 30 days prior to the imaging visit.
Progressive Supranuclear Palsy subjects:
* The participant is 30 years or older.
* Participants have a clinical diagnosis of PSP based on National Institute of Neurological Disorders and Stroke/ (NINDS) and the Society for PSP (SPSP) criteria (Litvan, et al. 1996).
Chronic Traumatic Encephalopathy subjects:
* The pa…