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

Parkinson's Disease (PD) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02103894
• Other study ID #: MNI-777
• Status: Completed
• Phase: Phase 1
• First received: February 12, 2014
• Last updated: December 15, 2016
• Start date: February 2014
• Est. completion date: September 2016

Study information

• Verified date: December 2016
• Source: Molecular NeuroImaging
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease (AD)
• Aphasia, Primary Progressive
• Brain Diseases
• Brain Injuries
• Brain Injury, Chronic
• Chronic Traumatic Encephalopathy (CTE)
• Dementia
• Frontal Temporal Dementia (FTD)
• Frontotemporal Dementia
• Parkinson Disease
• Parkinson's Disease (PD)
• Pick Disease of the Brain
• Pick's Disease
• Progressive Supranuclear Palsy (PSP)
• Supranuclear Palsy, Progressive
• Tauopathies

Intervention

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 ß-amyloid uptake (measured by [18F]florbetapir imaging) and tau protein uptake (measured by [18F]MNI-777 PET imaging). For individuals with Parkinsonian symptoms, [123I]ß-CIT SPECT imaging may be performed to evaluate for a reduction in dopamine transporter uptake.

Locations

Country	Name	City	State
United States	Molecular NeuroImaging, LLC	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Molecular NeuroImaging	Institute for Neurodegenerative Disorders

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Review. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain uptake of [18F]T807 ([18F]MNI-777)	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).	2 years	No

External Links

•   Institute for Neurodegenerative Disorders
•   Molecular NeuroImaging