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

COMPLETEDEARLY_PHASE1

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

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

NCT03080051•Molecular NeuroImaging

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - 90 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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.
•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
•Males and females aged between 50 and 90 years.
+7 more criteria

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).
•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).
•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.
+5 more criteria

Locations (1)

Molecular NeuroImaging, LLC

New Haven, Connecticut, United States

Key Dates

Start Date

August 1, 2016

Primary Completion Date

March 6, 2017

Completion Date

March 6, 2017

Last Updated

October 6, 2017

Enrollment

ACTUAL participants

Conditions

Progressive Supranuclear PalsyAlzheimer DiseaseHealthy Volunteers

Interventions

[18F]MNI-952

DRUG

[18F]Florbetapir

DRUG

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

NCT07310264

Healthy Volunteers (HV)Parkinson's Disease (PD)

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RECRUITINGPHASE1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

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Healthy ParticipantsHealthy Subjects+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 6, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

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