Clinical trial NCT02103894: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease (AD)
Parkinson's Disease (PD)
Chronic Traumatic Encephalopathy (CTE)
Progressive Supranuclear Palsy (PSP)
Frontal Temporal Dementia (FTD)
Pick's Disease
Tauopathies
Keywords: Alzheimer's disease (AD)
Parkinson's disease (PD)
Progressive supranuclear palsy (PSP)
Chronic traumatic encephalopathy (CTE)
Frontal temporal dementia (FTD)
Pick's disease
tauopathies
Lead sponsor: Molecular NeuroImaging
Sponsor class: OTHER
Collaborators: name: Institute for Neurodegenerative Disorders
First posted: 2014-04-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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.


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

Primary outcomes:
measure: Brain uptake of [18F]T807 ([18F]MNI-777)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Molecular NeuroImaging, LLC
state: Connecticut
Study officials:
affiliation: Institute for Neurodegenerative Disorders
name: Danna Jennings, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jordan BD. The clinical spectrum of sport-related traumatic brain injury. Nat Rev Neurol. 2013 Apr;9(4):222-30. doi: 10.1038/nrneurol.2013.33. Epub 2013 Mar 12.
citation: McKhann G, Drachman D, Folstein M, Katzman R, Price D, Stadlan EM. Clinical diagnosis of Alzheimer's disease: report of the NINCDS-ADRDA Work Group under the auspices of Department of Health and Human Services Task Force on Alzheimer's Disease. Neurology. 1984 Jul;34(7):939-44. doi: 10.1212/wnl.34.7.939.
citation: Litvan I, Agid Y, Calne D, Campbell G, Dubois B, Duvoisin RC, Goetz CG, Golbe LI, Grafman J, Growdon JH, Hallett M, Jankovic J, Quinn NP, Tolosa E, Zee DS. Clinical research criteria for the diagnosis of progressive supranuclear palsy (Steele-Richardson-Olszewski syndrome): report of the NINDS-SPSP international workshop. Neurology. 1996 Jul;47(1):1-9. doi: 10.1212/wnl.47.1.1.