Brief Title
Evaluation of [18F]MNI-777 PET as a Marker of Tau Pathology in Subjects With Tauopathies Compared to Healthy Subjects
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
Brief 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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Brain uptake of [18F]T807 ([18F]MNI-777)
Condition
Alzheimer's Disease (AD)
Intervention
[18F]T807 ([18F]MNI-777)
Study Arms / Comparison Groups
[18F]T807 ([18F]MNI-777)
Description: At the [18F]MNI-777 PET imaging visit, subjects will be injected with no more than 10 mCi (370 MBq) of [18F]MNI-777).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
16
Start Date
February 2014
Completion Date
September 2016
Primary Completion Date
August 2016
Eligibility Criteria
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 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.
- Negative history of neurological or psychiatric illness based on evaluation by a
research physician.
- MMSE score must be 29 or above.
Exclusion Criteria:
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
Gender
All
Ages
18 Years - 85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Danna Jennings, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02103894
Organization ID
MNI-777
Responsible Party
Principal Investigator
Study Sponsor
Molecular NeuroImaging
Collaborators
Institute for Neurodegenerative Disorders
Study Sponsor
Danna Jennings, MD, Principal Investigator, Institute for Neurodegenerative Disorders
Verification Date
December 2016