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Progressive Supranuclear PalsyEarly Phase 1NCT03080051

Evaluation of [18F]MNI-952 as a Potential PET Radioligand for Imaging Tau Protein in the Brain

A Early Phase 1 study testing [18F]MNI-952 and [18F]Florbetapir in people with Progressive Supranuclear Palsy and Alzheimer Disease, 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 overall goal of this imaging trial is to evaluate [18F]MNI-952 (also known as [18F]UCB-K), a tau targeted PET radioligand. Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
What is being tested?
[18F]MNI-952 and [18F]Florbetapir
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
Aug 2016to 6 Mar 2017
Phase
Early 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 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Written informed consent must be obtained before any assessment is performed.
  • Female subjects must be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral oophorectomy, or tubal ligation) or post-menopausal for at least 1 year or, if they are of child-bearing potential, must commit to use a barrier contraception method for the duration of the study.
  • Male subjects and their partners of childbearing potential must commit to the use of two methods of contraception, one of which is a barrier method for male subjects for the study duration.
  • Male subjects must not donate sperm for study duration and for 90 days following participation.
  • Willing and able to cooperate with study procedures
  • Males and females aged <55 years. Healthy with no clinically relevant finding on physical examination at screening and upon reporting for the [18F]MNI-952 imaging visit.
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  • No neurologic impairment as judged by the investigator
  • No family history of Alzheimer's disease or neurological disease associated with dementia
  • Have a CDR score=0
  • Inclusion Criteria for subjects with a diagnosis of probable Alzheimer's disease (AD):
  • Males and females aged between 50 and 90 years.
  • Have probable Alzheimer's disease, based on the NINCDS/ADRDA and DSM-IV criteria.
  • Have a CDR score of 0.5 or greater at screening.
  • Have an MMSE score ≤ 28.
  • Have a screening [18F]florbetapir PET imaging demonstrating amyloid binding based on qualitative (visual read)
  • A brain MRI that supports a diagnosis of AD, with no evidence of focal disease to account for dementia or MRI exclusion criteria.
  • Medications taken for symptomatic treatment of AD must be maintained on a stable dosage regimen for at least 30 days before the screening visit
  • The subject has an appropriate caregiver capable of accompanying subject, if necessary.
  • Signed and dated written informed consent obtained from the subject and/or the subject's legally authorized representative or caregiver (if applicable).
  • Inclusion Criteria for subjects with a diagnosis of probable Progressive Supranuclear Palsy (PSP):
  • Males and females aged 50 to 90 years.
  • Has a clinical diagnosis of PSP based on the NINDS and Society for PSP criteria (Litvan, et al 1996).
  • Have screening DaTSCAN SPECT imaging demonstrating evidence of dopamine transporter deficit based on qualitative (visual) read.
  • A brain MRI that supports a diagnosis of PSP, with no evidence of focal disease or MRI exclusion criteria.
  • Medications taken for symptomatic treatment of PSP must be maintained on a stable dosage regimen for at least 30 days before screening visit.
  • The subject has an appropriate caregiver capable of accompanying subject, if necessary.
  • Signed and dated written informed consent obtained from the subject and the subject's legally authorized representative or caregiver (if applicable).

Who cannot join

  • Current or prior history of any alcohol or drug abuse.
  • Laboratory tests with clinically significant abnormalities and/or clinically significant unstable medical illness.
  • Subject has received an investigational drug or device within 30 days of screening
  • Prior participation in other research protocols or clinical care in the last year such that radiation exposure exceeds the effective dose of 50 mSv, which would be above the acceptable annual limit established by the US Federal Guidelines.
  • Pregnancy, lactating or breastfeeding.
  • Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.
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  • Unsuitable veins for repeated venipuncture.
  • MRI exclusion criteria include: Findings of cerebrovascular disease (more than two lacunar infarcts, any territorial infarct >1cm3, or deep white matter abnormality corresponding to an overall Fazekas scale of 3 with at least one confluent hyperintense lesion on the FLAIR sequence that is ≥20 mm in any dimension), infectious disease, space-occupying lesions, normal pressure hydrocephalus or any other abnormalities associated with CNS disease.
  • Implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips and other medical implants that have not been certified for MRI, or history of claustrophobia in MRI.
  • Has received treatment that targeted amyloid-β or tau within the last 3 months.

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: Phase 0 Evaluation of [18F]MNI-952 as a Potential PET Radioligand for Imaging Tau Protein in the Brain of Patients With Progressive Supranuclear Palsy or Alzheimer's Disease Compared to Healthy Volunteers

The overall goal of this imaging trial is to evaluate [18F]MNI-952 (also known as [18F]UCB-K), a tau targeted PET radioligand.

Read the detailed description

The overall goal of this imaging trial is to evaluate [18F]MNI-952 (also known as [18F]UCB-K), a tau targeted PET radioligand.

  • To characterize [18F]MNI-952, a PET radioligand for imaging tau.
  • To visually and quantitatively assess brain uptake and pharmacokinetics of [18F]MNI-952, a PET imaging marker for tau pathology in individuals with Progressive Supranuclear Palsy (PSP) or Alzheimer's disease (AD) and compare with healthy volunteers (HV).
  • To evaluate the safety of a single injection of [18F]MNI-952.
  • To compare the distribution of tau (using [18F]MNI-952) and Aâ (using florbetapir) in AD subjects.
Being tested
[18F]MNI-952, [18F]Florbetapir
Keywords
PSP, AD, HV
Medical subject headings
Supranuclear Palsy, Progressive, Alzheimer Disease

What participants receive

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

  • [18F]MNI-952Drug

    Also called [18F]UCB-K

    Subjects will undergo PET imaging using [18F]MNI-952, a PET radioligand for imaging tau.

  • [18F]FlorbetapirDrug

    Subjects with Alzheimer's disease will receive a [18F]florbetapir scan to compare distribution of tau in the brain compared to that of [18F]MNI-952.

Study groups in NCT03080051
Study groupRoleWhat they receive
[18F]MNI-952ExperimentalTo evaluate [18F]MNI-952 (also known as [18F]UCB-K), a tau targeted PET radioligand.
Receives: Drug: [18F]MNI-952; Drug: [18F]Florbetapir

What is being measured

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

  1. Tracer uptake will be evaluated in regions of interest for analysis of regional [18F]MNI-952 binding/uptake and expressed in SUV by using established methods for normalization for 2 PSP, 2 AD, and 2 HV subjects.

    Descriptive statistics will be applied to describe the tau deposition by region as measured by [18F]MNI-952.

    Measured: 1 year

Timeline

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

  1. First posted15 Mar 2017
  2. Study startAug 2016
  3. Primary completion6 Mar 2017
  4. Study completion6 Mar 2017

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
Early Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03080051
Sponsor's protocol ID
[18F]MNI-952
Status last verified
Oct 2017
First submitted
12 Jan 2017
Last updated
6 Oct 2017
Results posted
No

Publications

  • 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 Early Phase 1 study testing [18F]MNI-952 and [18F]Florbetapir in people with Progressive Supranuclear Palsy and Alzheimer Disease, 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 10 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 6 Oct 2017. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Tracer uptake will be evaluated in regions of interest for analysis of regional [18F]MNI-952 binding/uptake and expressed in SUV by using established methods for normalization for 2 PSP, 2 AD, and 2 HV subjects. (time frame: 1 year). 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 NCT03080051, which also lists 1 linked publication.

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 6 Oct 2017.

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