- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02103894
Evaluation of [18F]MNI-777 PET as a Marker of Tau Pathology in Subjects With Tauopathies Compared to Healthy Subjects
December 15, 2016 updated by: Danna Jennings, Molecular NeuroImaging
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Connecticut
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New Haven, Connecticut, United States, 06510
- Molecular NeuroImaging, LLC
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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).
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain uptake of [18F]T807 ([18F]MNI-777)
Time Frame: 2 years
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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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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
February 12, 2014
First Submitted That Met QC Criteria
April 1, 2014
First Posted (Estimate)
April 4, 2014
Study Record Updates
Last Update Posted (Estimate)
December 16, 2016
Last Update Submitted That Met QC Criteria
December 15, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Metabolic Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Eye Diseases
- Neurologic Manifestations
- Wounds and Injuries
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Craniocerebral Trauma
- Trauma, Nervous System
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Cranial Nerve Diseases
- Ocular Motility Disorders
- Language Disorders
- Communication Disorders
- Paralysis
- Speech Disorders
- Frontotemporal Lobar Degeneration
- Ophthalmoplegia
- Aphasia
- Brain Injuries
- Brain Injury, Chronic
- Parkinson Disease
- Dementia
- Brain Injuries, Traumatic
- Alzheimer Disease
- Brain Diseases
- Frontotemporal Dementia
- Aphasia, Primary Progressive
- Pick Disease of the Brain
- Supranuclear Palsy, Progressive
- Tauopathies
- Chronic Traumatic Encephalopathy
Other Study ID Numbers
- MNI-777
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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