ClinicalTrials.gg
CompletedNCT02103894Updated Dec 16, 2016

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

A Phase 1 interventional study of [18F]T807 ([18F]MNI-777) in Alzheimer's Disease (AD), Parkinson's Disease (PD) and Chronic Traumatic Encephalopathy (CTE), sponsored by Molecular NeuroImaging. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-16.

Sponsored by Molecular NeuroImaging · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 22 studies testing flortaucipir in Alzheimer Disease — 4 open to participants now, 4 under way, none of them phase 3. flortaucipir · Alzheimer Disease.

Enrollment
18th of 22
16 · median 70
Started
2014
with 3 others
Phase 1
10 of 22
2 open now
Registered
4th of 22
by date
Lead sponsor
2 of 22
Molecular NeuroImaging

Among the 22 studies testing flortaucipir in Alzheimer Disease, this one is the 18th largest by enrollment, is one of 4 that started in 2014, is one of 10 in phase 1, and was the 4th registered.

By phase

22 studies; the count open now beside each. This study's row is marked.

Phase 1this study10 · 2 open
Phase 26 · 0 open
Phase 33 · 0 open
No phase1 · 1 open
Phase 2/31 · 0 open
Phase 41 · 1 open

By the year they started

First in 2013; this study’s year is marked. 4 started in 2014.

Tested beside flortaucipir

Size and results

Median enrollment 70 across the 22 interventional studies. Of the 17 that completed or were terminated, 15 (88%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 22 studies testing flortaucipir in Alzheimer Disease, or all of them as a file.
02

Study 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.

03

Conditions studied

  • 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
04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

For all subjects:

  • Written 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.
  • score must be 29 or above.

Exclusion criteria

Exclusion Criteria:

All subjects will be excluded from participation for the following reasons:

  • The subject has a 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 1
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • 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)

Interventions

  • 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

06

What researchers measure

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).

    Time frame: 2 years

07

Study locations

1 site
  • Molecular NeuroImaging, LLC
    New Haven, Connecticut 06510, United States
08

References and documents

Publications

  • 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. PubMed 23478462 ↗
  • 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. PubMed 6610841 ↗
  • 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. PubMed 8710059 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2014, a primary completion of Aug 2016 and a completion of Sep 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 12, 2014
First posted
Apr 4, 2014
Start
Feb 2014
Primary completionActual
Aug 2016
CompletionActual
Sep 2016
Last update
Dec 16, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02103894
Lead sponsor
Molecular NeuroImaging
Collaborators
Institute for Neurodegenerative Disorders
Responsible party
Danna Jennings (Principal Investigator, Molecular NeuroImaging) — Principal investigator
First posted
Apr 4, 2014
Start date
Feb 2014
Primary completion
Aug 2016
Completion
Sep 2016
Last update
Dec 16, 2016

Study contacts

Danna Jennings, MD
principal investigator · Institute for Neurodegenerative Disorders

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Flortaucipir

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