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

NCT03545789 | Completed Phase 1 FDA Drug

• 1 other identifier: [18F]MNI-958 Test-Retest
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers; Alzheimer Disease; Progressive Supranuclear Palsy

Keywords

HV; AD; 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 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.

  1 year

Study Arms (1)

[18F]MNI-958

EXPERIMENTAL

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.

Drug: [18F]MNI-958

Interventions

[18F]MNI-958 DRUG

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

Also known as: [18F]Florbetapir

[18F]MNI-958

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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 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.
• 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
• 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

You may not qualify if:

• 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.
• Unsuitable veins for repeated venipuncture.
• 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.

Sponsors & Collaborators

• Invicro: lead

Study Sites (1)

Invicro

New Haven, Connecticut, 06510, United States

Location

Related Links

• Description Related Info

MeSH Terms

Conditions

Alzheimer Disease; Supranuclear Palsy, Progressive

Interventions

florbetapir

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 Officials

• David Russell, M.D., Ph. D

  Invicro

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: June 4, 2018
• Study Start: March 12, 2018
• Primary Completion: February 6, 2020
• Study Completion: February 6, 2020
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

US (1)