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Alzheimer's Disease (AD)Phase 1NCT02103894

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

A Phase 1 study testing [18F]T807 ([18F]MNI-777) in people with Alzheimer's Disease (AD) and Parkinson's Disease (PD), run by Molecular NeuroImaging at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
What is being tested?
[18F]T807 ([18F]MNI-777)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
Feb 2014to Sep 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 27Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Molecular NeuroImaging, LLC

    New Haven, Connecticut, 06510

Other trials in United States

About this study

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

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.

Being tested
[18F]T807 ([18F]MNI-777)
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
Medical subject headings
Alzheimer Disease, Parkinson Disease, Chronic Traumatic Encephalopathy, Supranuclear Palsy, Progressive, Pick Disease of the Brain, Tauopathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [18F]T807 ([18F]MNI-777)Drug

    Also called [18F]T807, [18F]florbetapir, Amyvid, [123I]β-CIT

    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.

Study groups in NCT02103894
Study groupRoleWhat they receive
[18F]T807 ([18F]MNI-777)ExperimentalAt the [18F]MNI-777 PET imaging visit, subjects will be injected with no more than 10 mCi (370 MBq) of [18F]MNI-777).
Receives: Drug: [18F]T807 ([18F]MNI-777)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionAug 2016
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02103894
Sponsor's protocol ID
MNI-777
Status last verified
Dec 2016
First submitted
12 Feb 2014
Last updated
16 Dec 2016
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [18F]T807 ([18F]MNI-777) in people with Alzheimer's Disease (AD) and Parkinson's Disease (PD), run by Molecular NeuroImaging at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brain uptake of [18F]T807 ([18F]MNI-777) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02103894, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2016.

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