Safety and Effectiveness Study of Intranasal Insulin Glulisine on Cognitive and Memory in Mild-Mod AD Patients.
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.
Timeline
- Start
- 2011-09
- Primary completion
- 2013-06
- Completion
- 2013-06
Outcome
Met primary endpoint
registry analysis (superiority or other test); Post-Insulin Glulisine vs Post-Placebo; p <0.05; Percent Change -15.7; t-test, 2 sided; note: RBANS Line Orientation NCT01436045 ↗
registry analysis (superiority or other test); Post-Insulin Glulisine vs Post-Placebo; p <0.05; Mean Difference (Final Values) 0.92; t-test, 2 sided NCT01436045 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Insulin glulisine | Protein / enzyme biologic | 20 iu | Intranasal |