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NCT03239561 · ClinicalTrials.gov registry record · Early Phase 1
Evaluation of Tau Protein in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants
A Early Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 15
- Enrollment target
NCT03239561: Completed Early Phase 1 study, sponsored by Janssen Research & Development.
NCT03239561 is a Early Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 15 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03239561, a Early Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 15 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG [18F]MNI-1020
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2017-09-06 |
| Est. Completion | 2018-04-30 |
| Phase | Early Phase 1 |
What the finished NCT03239561 record still lists
NCT03239561 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which [18F]MNI-1020 is the first listed.
NCT03239561 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03239561 about?
NCT03239561 is a clinical study titled "Evaluation of Tau Protein in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants". 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 p...
What is the current status of trial NCT03239561?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2017-09-06. Estimated completion is 2018-04-30.
What interventions are being tested in trial NCT03239561?
The interventions under investigation include: [18F]MNI-1020 (DRUG).
Who is sponsoring clinical trial NCT03239561?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03239561's enrollment target sits among peer trials
15 1404th of 2000 higher than 527 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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