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NCT01561378 · ClinicalTrials.gov registry record · Phase 2
Cardiac Surgery Neuroprotection Study in Elders
A Phase 2 study, sponsored by Albert Einstein College of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT01561378: Completed Phase 2 study, sponsored by Albert Einstein College of Medicine.
NCT01561378 is a Phase 2 study that has completed, run by Albert Einstein College of Medicine. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01561378, a Phase 2 study, has completed, sponsored by Albert Einstein College of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study Summary
The goal of this study is to determine the potential ability of intranasal insulin to prevent post-operative cognitive decline and post-operative delirium in an elderly cardiac surgery population.
Primary Outcome
Assessed using a battery of cognitive tests which test the following four domains: 1) executive function, 2) verbal memory, 3) attention and concentration, 4) language. Cognitive testing will be performed at the following time points: baseline (1-2 weeks prior to surgery) and 6 weeks after discharge.
Interventions
- DRUG Normal saline
- DRUG Aspart insulin
- DEVICE Intranasal mucosal atomizer device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2012-08 |
| Est. Completion | 2014-10 |
| Phase | Phase 2 |
What the finished NCT01561378 record still lists
NCT01561378 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 3 interventions - of which Normal saline is the first listed.
NCT01561378 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01561378 about?
NCT01561378 is a clinical study titled "Cardiac Surgery Neuroprotection Study in Elders". The goal of this study is to determine the potential ability of intranasal insulin to prevent post-operative cognitive decline and post-operative delirium in an elderly cardiac surgery population.
What is the current status of trial NCT01561378?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2012-08. Estimated completion is 2014-10.
What interventions are being tested in trial NCT01561378?
The interventions under investigation include: Normal saline (DRUG), Aspart insulin (DRUG), Intranasal mucosal atomizer device (DEVICE).
Who is sponsoring clinical trial NCT01561378?
This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01561378's enrollment target sits among peer trials
22 1790th of 2000 higher than 207 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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