NCT01436045

Safety and Effectiveness Study of Intranasal Insulin Glulisine on Cognitive and Memory in Mild-Mod AD Patients.

A Double-Blind, Placebo-Controlled Single Dose Study of the Safety and Efficacy of Glulisine on Cognitive Function and Memory in Individuals Diagnosed With Probable Mild to Moderate Alzheimer's Disease/Intranasal Insulin Study.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: HealthPartners Institute · Academic / Other
• Sex: All
• Age: 65 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A single center, phase II randomized, double-blind, placebo-controlled, cross-over study designed to assess the efficacy and safety of intranasally (IN) delivered insulin glulisine versus placebo in patients aged 65-85 with mild-moderate Alzheimer's Disease (AD). Twelve AD subjects (six female and six male) will be randomized to receive a single dose of either 20 IU/IN insulin glulisine or placebo using the MAD 300 device.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Insulin glulisine	Single treatment, 20 IU/Intranasal (.1ml/10 units Intranasally in each nostril)
DRUG	Saline	Single treatment,(saline) 20 IU/Intranasal (.1ml/10units intranasally in each nostril)

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2011-09-19
• Last updated: 2015-10-19
• Results posted: 2015-10-19

Locations

1 site across 1 country: United States