Evaluation of Tau Protein in the Brain of Participants Wi... | NCT03239561

NCT03239561

Protocol Section

Identification Module

Results Section

No data available

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Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
64326067EDI0001	Other Identifier	Janssen Research & Development, LLC

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
[18F]MNI-1020	Experimental	Participants will receive a single intravenous bolus injection of [18F]MNI-1020 at a dose of not more than 10 millicurie (mCi), with a maximum mass dose of 10 microgram (mcg) and maximum volume of 10 milliliter (mL) at imaging visit.	Drug: [18F]MNI-1020

Interventions

Name	Type	Description	Arm Group Labels	Other Names
[18F]MNI-1020	Drug	Participants will receive a single intravenous bolus injection of [18F]MNI-1020 at a dose of not more than 10 millicurie (mCi), with a maximum mass dose of 10 microgram (mcg) and maximum volume of 10 milliliter (mL) at imaging visit.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Standardized Uptake Value Ratio (SUVR) of [18F]MNI-1020	Tracer uptake will be expressed in Standardized Uptake Value Ratio (SUVR). Regions used for tracer uptake quantitation will include cortical regions (frontal cortex, posterior cingulate, lateral temporal cortex, parietal cortex, occipital cortex, mesial temporal cortex, inferior temporal cortex, hippocampus, and anterior cingulate). Subcortical regions (basal ganglia, substantia nigra, choroid plexus) will be used for detection of possible off-target binding. Regions predicted to be free of tau pathology will be used as reference (cerebellum and pons). SUVR will be calculated as SUV target/SUV reference region (e.g., cerebellar gray).	Up to 180 minutes after tracer injection on Day 1
Plasma Concentration of 18F]MNI-1020 in AD Participants Compared With age Matched Healthy Participants	Pharmacokinetics of [18F]MNI-1020 will be assessed by using plasma concentration data and compared in participants with probable Alzheimer's disease (AD) and age matched healthy participants.	Pre-injection, 5, 10, 30, and 60 minutes post-injection
Number of Participants With Adverse Events	An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.	Baseline up to Follow-Up (Day 4)
Distribution of tau (Using [18F]MNI-1020) Compared to Amyloid Beta (Using Florbetapir) in Participants With Probable AD	Within the AD participants, the distribution and binding of [18F]florbetapir will be compared to the [18F]MNI-1020 binding across multiple regions. This will be done by visual reading of scans, with amyloid signal predicted to be high in frontal cortical regions in participants with probable AD and absent from cortex in healthy participants, while tau signal is predicted to be present in hippocampus and entorhinal cortex in healthy elderly participants, and in medial and lateral temporal cortex in participants with probable AD. Semi-quantitative analysis will also be conducted comparing SUVR of the tracers in these same regions, using cerebellum as reference.

Eligibility Module

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

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases