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

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ClinicalTrials.gov Identifier: NCT02103894
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : December 16, 2016
Sponsor:
Collaborator:
Institute for Neurodegenerative Disorders
Information provided by (Responsible Party):
Danna Jennings, Molecular NeuroImaging

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease (AD) Parkinson's Disease (PD) Chronic Traumatic Encephalopathy (CTE) Progressive Supranuclear Palsy (PSP) Frontal Temporal Dementia (FTD) Pick's Disease Tauopathies Drug: [18F]T807 ([18F]MNI-777) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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 Start Date : February 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : September 2016


Arm Intervention/treatment
Experimental: [18F]T807 ([18F]MNI-777)
At the [18F]MNI-777 PET imaging visit, subjects will be injected with no more than 10 mCi (370 MBq) of [18F]MNI-777).
Drug: [18F]T807 ([18F]MNI-777)
All enrolled subjects will undergo an [18F]MNI-777 PET imaging visit. For individuals with AD or CTE, [18F]florbetapir imaging may also be performed to serve as a means of correlating disease severity by evaluating the relationship of β-amyloid uptake (measured by [18F]florbetapir imaging) and tau protein uptake (measured by [18F]MNI-777 PET imaging). For individuals with Parkinsonian symptoms, [123I]β-CIT SPECT imaging may be performed to evaluate for a reduction in dopamine transporter uptake.
Other Names:
  • [18F]T807
  • [18F]florbetapir
  • Amyvid
  • [123I]β-CIT




Primary Outcome Measures :
  1. Brain uptake of [18F]T807 ([18F]MNI-777) [ Time Frame: 2 years ]
    To quantitatively assess the brain uptake of [18F]MNI-777 ([18F]T807), an imaging biomarker for tau pathology in brain, using positron emission tomography (PET) in individuals with clinically diagnosed tauopathies including: Alzheimer's disease (AD), Parkinson's disease (PD), progressive supranuclear palsy (PSP), chronic traumatic encephalopathy (CTE) and frontal temporal dementia/Pick's disease (FTD) and healthy controls (HC).



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02103894


Locations
United States, Connecticut
Molecular NeuroImaging, LLC
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Molecular NeuroImaging
Institute for Neurodegenerative Disorders
Investigators
Principal Investigator: Danna Jennings, MD Institute for Neurodegenerative Disorders

Additional Information:
Publications:
Responsible Party: Danna Jennings, Principal Investigator, Molecular NeuroImaging
ClinicalTrials.gov Identifier: NCT02103894     History of Changes
Other Study ID Numbers: MNI-777
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: December 16, 2016
Last Verified: December 2016

Keywords provided by Danna Jennings, Molecular NeuroImaging:
Alzheimer's disease (AD)
Parkinson's disease (PD)
Progressive supranuclear palsy (PSP)
Chronic traumatic encephalopathy (CTE)
Frontal temporal dementia (FTD)
Pick's disease
tauopathies

Additional relevant MeSH terms:
Dementia
Pick Disease of the Brain
Frontotemporal Dementia
Frontotemporal Lobar Degeneration
Parkinson Disease
Alzheimer Disease
Brain Diseases
Supranuclear Palsy, Progressive
Aphasia, Primary Progressive
Tauopathies
Brain Injuries, Traumatic
Chronic Traumatic Encephalopathy
Parkinsonian Disorders
Basal Ganglia Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Paralysis
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Aphasia
Speech Disorders
Language Disorders