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

Early Phase 1

Completed

• Conditions: Alzheimer Disease; Healthy Volunteers; Progressive Supranuclear Palsy
• Interventions: Drug: [18F]MNI-958; Drug: [18F]Florbetapir; Drug: DaTscan

• Registration Number: NCT03058965
• Lead Sponsor: Molecular NeuroImaging

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-29
• Study First Submitted: 2017-01-12
• Study First Submitted QC: 2017-02-20
• Study First Posted: 2017-02-23
• Primary Completion: 2018-05-11
• Study Completion: 2018-05-11
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-21
• Last Update Posted: 2019-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

• 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.
• 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.
• MRI exclusion criteria include: 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.

Exclusion Criteria for Subjects with Probable AD:

• Has received treatment that targeted amyloid-β or tau within the last 3 months.

Exclusion Criteria for Subjects with Probable PSP:

• Ongoing treatment with methylphenidate, bupropion, modafinil, metoclopramide, alpha methyldopa, reserpine, or amphetamine derivative.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[18F]MNI-958	[18F]MNI-958	To evaluate \[18F\]MNI-958, a tau targeted PET radioligand.
[18F]MNI-958	[18F]Florbetapir	To evaluate \[18F\]MNI-958, a tau targeted PET radioligand.
[18F]MNI-958	DaTscan	To evaluate \[18F\]MNI-958, a tau targeted PET radioligand.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Molecular NeuroImaging, LLC; 🇺🇸 New Haven, Connecticut, United States