Evaluation of [18F]MNI-777 PET as a Marker of Tau Pathology in Subjects With Tauopathies Compared to Healthy Subjects

Completed · Phase 1

Conditions studied: Alzheimer's Disease (AD), Parkinson's Disease (PD), Chronic Traumatic Encephalopathy (CTE), Progressive Supranuclear Palsy (PSP), Frontal Temporal Dementia (FTD), Pick's Disease, Tauopathies

In brief

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.

Key facts

Study ID

NCT02103894

Run by

Molecular NeuroImaging

People needed

16

Starts

2014-02-01

Expected to finish

2016-09-01

Last updated by the study team

2016-12-16

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 participant is 18 years or older.
• Subjects with a diagnosis of probable CTE based on a prior history of repetitive brain trauma and at least one concussion, and a current mood disorder (depression, apathy, irritability, suicidal ideation), cognitive symptoms (memory loss, impaired executive function) or behavioral symptoms (disinhibition, aggression and increased violence) (Jordan, 2013).
• Frontal Temporal Dementia/Pick's disease subjects:
• The participant is 50 years or older.
• Participants have a clinical diagnosis of FTD based on consensus for clinical diagnosis of frontotemporal dementia (Neary, et al., 1998)
• Healthy Control subjects:
• The participant is 18 - 85 years old.

You may not qualify if…

• All subjects will be excluded from participation for the following reasons:
• The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness.
• The subject has any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including gastrointestinal surgery).
• The subject has evidence of a structural lesion on MRI that may interfere with interpretation of PET imaging.
• The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
• The subject has participated in another clinical study within the previous 30 days.
• Pregnancy or women who are nursing or breastfeeding

Where it is running

• Molecular NeuroImaging, LLC — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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