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



Status:Completed
Conditions:Alzheimer Disease, Parkinsons Disease, Infectious Disease, Neurology, Neurology, Neurology, Neurology, Neurology, Neurology, Psychiatric
Therapuetic Areas:Immunology / Infectious Diseases, Neurology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 85
Updated:12/17/2016
Start Date:February 2014
End Date:September 2016

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

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.


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
We found this trial at
1
site
New Haven, Connecticut
Principal Investigator: Danna Jennings, MD
Phone: 203-401-4300
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mi
from
New Haven, CT
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