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NCT01217021 · ClinicalTrials.gov registry record · Early Phase 1
Safety and Efficacy of Positron Emission Tomography (PET) Imaging With MNI-558
A Early Phase 1 study, sponsored by Institute for Neurodegenerative Disorders.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
NCT01217021: Completed Early Phase 1 study, sponsored by Institute for Neurodegenerative Disorders.
NCT01217021 is a Early Phase 1 study that has completed, run by Institute for Neurodegenerative Disorders. The registered enrollment target is 10 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01217021, a Early Phase 1 study, has completed, sponsored by Institute for Neurodegenerative Disorders.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This research will look at how the brain may change in people with Alzheimer disease (AD). The purpose of this research is to find out whether changes in the brain in people with Alzheimer disease can be detected using a brain imaging test. Most people with Alzheimer disease have changes in the brain that result in deposits of a protein called beta-amyloid. In this study, the investigators will be using a radioactive drug, \[18F\]MNI-558 that binds to beta-amyloid. This drug is experimental and has not been approved by the FDA. Brain imaging using PET (positron emission tomography) will be done to see if the investigators can evaluate the areas of beta-amyloid in the subjects with Alzheimer disease. The investigators will compare these scans with those done in healthy normal volunteers. PET is a brain-scanning test used in medicine and scientific research to see how the brain is working. The PET imaging test used in this study is not being done for diagnostic purposes.
Primary Outcome
To determine diagnostic efficacy of the MNI-558 PET scans in differentiating between patients with probable AD and HVs on the basis of neocortical tracer binding pattern, the PET scans will be visually assessed by a nuclear physician experienced in the field of neuro-imaging. Safety will be assessed from the rates of adverse events (AEs), changes in vital signs, changes in ECG parameters, changes in physical examination findings, changes in clinical laboratory findings, changes in injection sit
Interventions
- DRUG [18F] MNI-558
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2010-09 |
| Est. Completion | 2011-03 |
| Phase | Early Phase 1 |
What the finished NCT01217021 record still lists
NCT01217021 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which [18F] MNI-558 is the first listed.
NCT01217021 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01217021 about?
NCT01217021 is a clinical study titled "Safety and Efficacy of Positron Emission Tomography (PET) Imaging With MNI-558". This research will look at how the brain may change in people with Alzheimer disease (AD). The purpose of this research is to find out whether changes in the brain in people with Alzheimer disease can be detected using a brain imaging test. Most people with Alzheimer disease have changes in the bra...
What is the current status of trial NCT01217021?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2010-09. Estimated completion is 2011-03.
What interventions are being tested in trial NCT01217021?
The interventions under investigation include: [18F] MNI-558 (DRUG).
Who is sponsoring clinical trial NCT01217021?
This trial is sponsored by Institute for Neurodegenerative Disorders, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01217021's enrollment target sits among peer trials
10 1629th of 2000 higher than 256 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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