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

Sponsor

Molecular NeuroImaging (Other)

Overall Status

Completed

CT.gov ID

NCT02103894

Collaborator

Institute for Neurodegenerative Disorders (Other)

Enrollment

Location

Arm

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

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 :

Feb 1, 2014

Actual Primary Completion Date :

Aug 1, 2016

Actual Study Completion Date :

Sep 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Brain uptake of [18F]T807 ([18F]MNI-777) [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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