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

NCT02103894 | Completed Phase 1

• 1 other identifier: MNI-777
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

[18F]T807 ([18F]MNI-777)

EXPERIMENTAL

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)

Interventions

[18F]T807 ([18F]MNI-777) DRUG

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.

Also known as: [18F]T807, [18F]florbetapir, Amyvid, [123I]β-CIT

[18F]T807 ([18F]MNI-777)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Molecular NeuroImaging: lead
• Institute for Neurodegenerative Disorders: collaborator

Study Sites (1)

Molecular NeuroImaging, LLC

New Haven, Connecticut, 06510, United States

Location

Related 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. Epub 2013 Mar 12.

  PMID: 23478462 BACKGROUND

• 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.

  PMID: 6610841 BACKGROUND

• 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.

  PMID: 8710059 BACKGROUND

Related Links

• Molecular NeuroImaging
• Institute for Neurodegenerative Disorders

MeSH Terms

Conditions

Alzheimer Disease; Parkinson Disease; Chronic Traumatic Encephalopathy; Supranuclear Palsy, Progressive; Pick Disease of the Brain; Tauopathies

Interventions

7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole; florbetapir

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Brain Injuries, Traumatic; Brain Injuries; Brain Injury, Chronic; Craniocerebral Trauma; Trauma, Nervous System; Brain Damage, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Frontotemporal Dementia; Frontotemporal Lobar Degeneration

Study Officials

• Danna Jennings, MD

  Institute for Neurodegenerative Disorders

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: April 4, 2014
• Study Start: February 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 16, 2016

Record last verified: 2016-12

Locations

US (1)