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NCT01859767 · ClinicalTrials.gov registry record · Phase 1
Efficacy and Safety of MNI-672 SPECT for Detection/Exclusion of Cerebral B-amyloid in AD Subjects Compared to HVs.
A Phase 1 study of Alzheimers Disease, sponsored by Molecular NeuroImaging.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT01859767: Completed Phase 1 study of Alzheimers Disease, sponsored by Molecular NeuroImaging.
NCT01859767 is a Phase 1 study of Alzheimers Disease that has completed, run by Molecular NeuroImaging. The registered enrollment target is 6 participants, below the 3,926-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01859767, a Phase 1 study of Alzheimers Disease, has completed, sponsored by Molecular NeuroImaging.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 1, single center, open-label, non-randomized, clinical study in probable AD patients and HVs to evaluate the efficacy, safety and tolerability of a single dose of MNI-672. The underlying goal of this study is to assess MNI-672 SPECT imaging as a tool to detect ß amyloid deposition in the brain of AD research participants and young healthy male subjects. All study procedures will be conducted at Molecular NeuroImaging (MNI) in New Haven, CT. Approximately 3 patients with AD and 3 young male HVs will be recruited to participate in this study. HVs will be screened to ensure that there is no evidence of cognitive decline or significant neurological deficit. All eligible subjects will be required to visit the study center on at least 2 occasions: 1. for one or more screening visits which should include a history and physical examination, laboratory and extensive neuro-psychological testing and MRI brain scanning. AD subjects will also undergo Amyvid PET imaging as part of the Screening Visit. 2. on one day for baseline examinations and MNI-672 administration and subsequent SPECT scanning- followed by safety measures
Primary Outcome
Safety will be assessed by the number of participants with adverse events.
Conditions Studied
Interventions
- DRUG [123I]MNI-672 SPECT
Study Locations (1)
Connecticut
- Molecular NeuroImaging, LLC - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2013-04 |
| Est. Completion | 2015-04 |
| Phase | Phase 1 |
What the finished NCT01859767 record still lists
NCT01859767 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 3,926-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Alzheimers Disease appearing as the primary indexed condition, and to 1 intervention - of which [123I]MNI-672 SPECT is the first listed.
NCT01859767 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT01859767 about?
NCT01859767 is a clinical study titled "Efficacy and Safety of MNI-672 SPECT for Detection/Exclusion of Cerebral B-amyloid in AD Subjects Compared to HVs.". This is a Phase 1, single center, open-label, non-randomized, clinical study in probable AD patients and HVs to evaluate the efficacy, safety and tolerability of a single dose of MNI-672. The underlying goal of this study is to assess MNI-672 SPECT imaging as a tool to detect ß amyloid deposition in...
What is the current status of trial NCT01859767?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2013-04. Estimated completion is 2015-04.
What conditions does trial NCT01859767 study?
This clinical trial studies the following conditions: Alzheimers Disease.
What interventions are being tested in trial NCT01859767?
The interventions under investigation include: [123I]MNI-672 SPECT (DRUG).
Who is sponsoring clinical trial NCT01859767?
This trial is sponsored by Molecular NeuroImaging, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01859767 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01859767's enrollment target sits among peer trials
6 146th of 147 higher than 1 of 147 other Alzheimers Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimers Disease 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.
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