Clinical trial NCT03239561: Evaluation of Tau Protein in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants
Official title: Phase 0 Exploratory Study of [18F]MNI-1020 (Also Known as [18F]JNJ-64326067) as an Imaging Marker for Tau Protein in the Brain of Subjects With Alzheimer's Disease Compared to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2017-08-04
Enrollment: 15
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary objectives of this study are to characterize \[18F\]molecular neuroimaging (MNI)-1020, a positron emission tomography (PET) radioligand for imaging tau pathology, to visually and quantitatively assess and compare brain uptake and pharmacokinetics of \[18F\]MNI-1020 in participants with probable Alzheimer's disease (AD) and compare with age matched healthy participants, to evaluate the safety of a single injection of \[18F\]MNI-1020 and to compare the distribution of tau (using \[18F\]MNI-1020) and amyloid beta (using florbetapir) in participants with probable AD.


Eligibility criteria: Inclusion Criteria:

All Participants

* Female participants 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. Male participants 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 participants for the study duration
* Male participants must not donate sperm during the study and for 3 months after completion

Healthy Participants

* Males and females aged greater than or equal 50 years. Healthy with no clinically relevant finding on physical examination at screening and upon reporting for the \[18F\]molecular neuroimaging (MNI)-1020 imaging visit
* Have screening \[18F\]florbetapir positron emission tomography (PET) imaging demonstrating no significant amyloid binding based on qualitative analysis (visual read)

Alzheimer Disease - Have screening \[18F\]florbetapir or prior amyloid (in the last 12 months) PET imaging demonstrating amyloid binding based on qualitative (visual read)

Exclusion Criteria:

All Participants

* 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 millisievert (mSv), which would be above the acceptable annual limit established by the United States Federal Guidelines
* Unsuitable veins for repeated venipuncture
* Magnetic resonance imaging exclusion criteria include: evidence of cerebrovascular disease (more than two lacunar infarcts, any territorial infarct greater than 1 centimeter 3, 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 greater than or equal to 20 millimeter (mm) in any dimension), infectious disease, space-occupying lesions, normal pressure hydrocephalus or any other abnormalities associated with central nervous system disease
* Implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, central nervous system aneurysm clips and other medical implants that have not been certified for MRI, or history of claustrophobia in Magnetic Resonance Imaging (MRI)

Alzheimer Disease

- Has received treatment that targeted amyloid beta or tau within the last 3 months

Primary outcomes:
measure: Standardized Uptake Value Ratio (SUVR) of [18F]MNI-1020
timeFrame: Up to 180 minutes after tracer injection on Day 1
measure: Plasma Concentration of 18F]MNI-1020 in AD Participants Compared With age Matched Healthy Participants
timeFrame: Pre-injection, 5, 10, 30, and 60 minutes post-injection
measure: Number of Participants With Adverse Events
timeFrame: Baseline up to Follow-Up (Day 4)
measure: Distribution of tau (Using [18F]MNI-1020) Compared to Amyloid Beta (Using Florbetapir) in Participants With Probable AD
timeFrame: Screening for Florbetapir; Day 1 for [18F]MNI-1020
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Invicro
state: Connecticut
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: