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NCT01436045 · ClinicalTrials.gov registry record · Phase 2
Safety and Effectiveness Study of Intranasal Insulin Glulisine on Cognitive and Memory in Mild-Mod AD Patients.
A Phase 2 study of Alzheimers Disease, sponsored by HealthPartners Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT01436045: Completed Phase 2 study of Alzheimers Disease, sponsored by HealthPartners Institute.
NCT01436045 is a Phase 2 study of Alzheimers Disease that has completed, run by HealthPartners Institute. The registered enrollment target is 12 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
NCT01436045, a Phase 2 study of Alzheimers Disease, has completed, sponsored by HealthPartners Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to investigate the effect of the rapidly acting intranasal insulin derivative (glulisine) on memory and cognition in 12 patients suffering from mild-moderate Alzheimer's Disease (AD) using a double-blind placebo-controlled single dose study. This study will further assess safety of insulin glulisine as well as the effects of this drug on olfaction.
Primary Outcome
The results are presented as a mean number of correct responses for each cognitive assessment. For each of these, a lower number correct is indicative of a higher cognitive deficit. Ranges are as follows: RBANS List Learning (0-40), RBANS Story Memory (0-24), RBANS Figure Copy (0-20), RBANSLine Orientation (0-20), RBANS Semantic Fluency (0-unlimited), RBANS List Recall (0-10), RBANS List Recognition (0-20), RBANS Story Recall (0-12), RBANS Figure Recall (0-20), Digit Span Forward (0-16), Digit
Conditions Studied
Interventions
- DRUG Saline
- DRUG Insulin glulisine
Study Locations (1)
Minnesota
- HealthPartners Specialty Center - Center for Dementia & Alzheimer's Care - Saint Paul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2011-09 |
| Est. Completion | 2013-06 |
| Phase | Phase 2 |
What the finished NCT01436045 record still lists
NCT01436045 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 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 2 interventions - of which Saline is the first listed.
NCT01436045 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT01436045 about?
NCT01436045 is a clinical study titled "Safety and Effectiveness Study of Intranasal Insulin Glulisine on Cognitive and Memory in Mild-Mod AD Patients.". The purpose of this study is to investigate the effect of the rapidly acting intranasal insulin derivative (glulisine) on memory and cognition in 12 patients suffering from mild-moderate Alzheimer's Disease (AD) using a double-blind placebo-controlled single dose study. This study will further asses...
What is the current status of trial NCT01436045?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2011-09. Estimated completion is 2013-06.
What conditions does trial NCT01436045 study?
This clinical trial studies the following conditions: Alzheimers Disease.
What interventions are being tested in trial NCT01436045?
The interventions under investigation include: Saline (DRUG), Insulin glulisine (DRUG).
Who is sponsoring clinical trial NCT01436045?
This trial is sponsored by HealthPartners Institute, which has 146 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01436045 being conducted?
This trial has 1 study location across Minnesota. 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 NCT01436045's enrollment target sits among peer trials
12 139th of 147 higher than 6 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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