Phase 0 Evaluation of [18F]MNI-958 as a Potential PET Radioligand for Imaging Tau Protein in the Brain

NCT03058965 | Completed Early Phase 1

• 1 other identifier: [18F]MNI-958
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this imaging trial is to evaluate \[18F\]MNI-958, a tau targeted PET radioligand, in individuals with Alzheimer's disease (AD), Progressive Supranuclear Palsy (PSP), and healthy volunteers (HV).

Conditions

Alzheimer Disease; Healthy Volunteers; Progressive Supranuclear Palsy

Keywords

AD; HV; PSP

Outcome Measures

Primary Outcomes (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 3 AD, 3 PSP, and 3 HV subjects.

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

  1 year

Study Arms (1)

[18F]MNI-958

EXPERIMENTAL

To evaluate \[18F\]MNI-958, a tau targeted PET radioligand.

Drug: [18F]MNI-958; Drug: [18F]Florbetapir; Drug: DaTscan

Interventions

[18F]MNI-958 DRUG

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

[18F]MNI-958

[18F]Florbetapir DRUG

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-958.

[18F]MNI-958

DaTscan DRUG

DaTscan SPECT imaging will be completed in those PSP subjects who have not previously had DATScan imaging as part of the screening procedures.

[18F]MNI-958

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.
• No cognitive impairment from neuropsychological battery as judged by the investigator
• Have screening \[18F\]florbetapir PET imaging demonstrating no significant amyloid binding based on qualitative analysis (visual read).
• No family history of Alzheimer's disease or neurological disease associated with dementia
• Have a CDR score=0
• Males and females aged 50 to 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 screening or prior (in the last 12 months) \[18F\]florbetapir PET imaging demonstrating amyloid binding based on qualitative (visual read)

You may not qualify if:

• Medications taken for symptomatic treatment of AD must be maintained on a stable dosage regimen for at least 30 days before the screening visit.
• Signed and dated written informed consent obtained from the subject and the subject's legally authorized representative or caregiver (if applicable).
• The subject has an appropriate caregiver capable of accompanying subject, if necessary.
• 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 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.
• Signed and dated written informed consent obtained from the subject and the subject's legally authorized representative or caregiver (if applicable).
• The subject has an appropriate caregiver capable of accompanying subject, if necessary.
• 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 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.

Sponsors & Collaborators

• Molecular NeuroImaging: lead

Study Sites (1)

Molecular NeuroImaging, LLC

New Haven, Connecticut, 06510, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Alzheimer Disease; Supranuclear Palsy, Progressive

Interventions

florbetapir; ioflupane

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Basal Ganglia Diseases; Movement Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: February 23, 2017
• Study Start: November 29, 2016
• Primary Completion: May 11, 2018
• Study Completion: May 11, 2018
• Last Updated: March 25, 2019

Record last verified: 2019-03

Locations

US (1)