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Healthy VolunteersPhase 1NCT03545789

Phase 1 Test-retest Evaluation of [18F]MNI-958 PET

A Phase 1 study testing [18F]MNI-958 in people with Healthy Volunteers and Alzheimer Disease, run by Invicro 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 protocol is to evaluate [18F]MNI-958 also known as APN-0000455 or PM-PBB3, a tau targeted radiopharmaceutical. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
What is being tested?
[18F]MNI-958
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
12 Mar 2018to 6 Feb 2020
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 55 years
  • All sexes
  • Healthy volunteers accepted
  • 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 childbearing 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 the study duration.
  • Willing and able to cooperate with study procedures
  • Males and females aged ≥50 years. Healthy with no clinically relevant finding on physical examination at screening and upon reporting for the [18F]MNI-958 imaging visit.
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  • No cognitive impairment from neuropsychological battery as judged by the investigator
  • Have screening or prior (in the last 90 days) amyloid PET imaging demonstrating no significant amyloid binding based on qualitative (visual read).
  • No family history of Alzheimer's disease or neurological disease associated with dementia
  • Have a CDR global score=0
  • Have an MMSE score ≥28
  • Willing and able to cooperate with study procedures
  • Inclusion criteria for subjects with a diagnosis of probable
  • Alzheimer's disease (AD):
  • Males and females aged 50 to 80 years.
  • Have probable Alzheimer's disease dementia, based on the NINCDS/ADRDA and DSM-IV criteria, with mild severity and amnestic presentation
  • Have a CDR score ≥ 0.5 at screening
  • Have a MMSE score between ≤ 28.
  • Have screening or prior (in the last 12 months) amyloid PET imaging demonstrating amyloid binding based on qualitative analysis (visual read). Amyloid PET imaging results will be shared with participants, and scans may be used by participants for future research use.
  • A brain MRI that supports a diagnosis of AD, with no evidence of significant neurologic pathology.
  • Medications taken for symptomatic treatment of AD 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 on all visits.
  • Signed and dated written informed consent obtained from the subject and the subject's legally authorized representative or caregiver (if applicable).
  • Inclusion criteria for subjects with a diagnosis of Progressive Supranuclear Palsy (PSP)
  • Males and females aged 50 to 90 years.
  • Has a clinical diagnosis of probable PSP based on the NINDS and Society for PSP (NINDS-PSP) criteria (Litvan, et al 1996).
  • Have screening or prior DaTscan SPECT imaging demonstrating evidence of dopamine transporter deficit based on visual read.
  • A brain MRI that supports a diagnosis of PSP, with no other evidence of significant neurologic pathology
  • 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 (in the last 12 months) 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 in addition to the radiation exposure expected from participation in this clinical study, 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 that may be responsible for the neurologic status of the patient such as significant evidence 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 Aβ or tau within the last 3 months.
  • Ongoing treatment with methylphenidate, modafinil, metoclopramide, alpha methyldopa, reserpine, or amphetamine derivative for subjects requiring DaTscan imaging.
  • Subjects may take stable doses of bupropion, however this medication must be held for at least 12 hours prior to DaTscan imaging.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Invicro

    New Haven, Connecticut, 06510

Other trials in United States

About this study

Official title: Phase 1 Test-retest Evaluation of [18F]MNI-958 PET as an Imaging Marker for Tau Protein in the Brain of Patients With Alzheimer's Disease and Probable PSP as Compared to Healthy Volunteers

The overall goal of this protocol is to evaluate [18F]MNI-958 also known as APN-0000455 or PM-PBB3, a tau targeted radiopharmaceutical.

Read the detailed description

The overall goal of this protocol is to evaluate [18F]MNI-958 also known as APN-0000455 or PM-PBB3, a tau targeted radiopharmaceutical. The specific objectives are:

  • To measure the dynamic uptake and washout of [18F]MNI- 958 in brain using positron emission tomography (PET) in patients with Alzheimer's disease, Progressive Supranuclear Palsy and healthy volunteers.
  • To measure blood metabolites of [18F]MNI-958 and perform kinetic modeling to assess its ability to measure tau protein in brain using the tracer plasma concentration or a reference region as indirect input.
  • To obtain test/retest reliability of the tracer binding parameters in patients with Alzheimer's disease, Progressive Supranuclear Palsy and healthy volunteers.
  • To acquire safety data following injection of [18F]MNI-958.
Being tested
[18F]MNI-958
Keywords
HV, AD, PSP
Medical subject headings
Alzheimer Disease, Supranuclear Palsy, Progressive

What participants receive

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

  • [18F]MNI-958Drug

    Also called [18F]Florbetapir

    Subjects will undergo PET imaging using [18F]MNI-958, a PET radioligand for imaging tau.

Study groups in NCT03545789
Study groupRoleWhat they receive
[18F]MNI-958ExperimentalTo measure blood metabolites of [18F]MNI-958 and perform kinetic modeling to assess its ability to measure tau protein in brain using the tracer plasma concentration or a reference region as indirect input.
Receives: Drug: [18F]MNI-958

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-958 binding/uptake and expressed in SUV by using established methods for normalization for 4 AD, 7 PSP, and 3 HV subjects.

    Target regions of interest in the standard volume of interest (VOI) template, will be used for tracer uptake quantitation of potentially increased binding to tau pathology will correspond in particular to the cortical regions of the brain.

    Descriptive statistics will be applied to describe the tau deposition by region as measured by [18F]MNI-958.

    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 posted4 Jun 2018
  2. Study start12 Mar 2018
  3. Primary completion6 Feb 2020
  4. Study completion6 Feb 2020

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
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03545789
Sponsor's protocol ID
[18F]MNI-958 Test-Retest
Status last verified
Feb 2020
First submitted
15 Mar 2018
Last updated
17 Feb 2020
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [18F]MNI-958 in people with Healthy Volunteers and Alzheimer Disease, run by Invicro 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 31 inclusion and 12 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 17 Feb 2020. 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?

Tracer uptake will be evaluated in regions of interest for analysis of regional [18F]MNI-958 binding/uptake and expressed in SUV by using established methods for normalization for 4 AD, 7 PSP, and 3 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 NCT03545789.

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 17 Feb 2020; AzTrials last refreshed its copy on 7 Nov 2026.

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