Conditions: Alzheimer's Disease
Keywords: Memory Insulin glulisine Alzheimer's Disease
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 12
Healthy volunteers: no

Brief 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.

Arms:
arm 1: A randomized, double-blind, placebo-controlled, cross-over designed - all subject will receive intervention (insulin glulisine) and placebo (saline) during separate visits. arm 2: A randomized, double-blind, placebo-controlled, cross-over designed - all subject will receive intervention (insulin glulisine) and placebo (saline) during separate visits.

Interventions: intervention 1: Insulin glulisine intervention 2: Saline
Intervention descriptions: intervention 1: Single treatment, 20 IU/Intranasal (.1ml/10 units Intranasally in each nostril) intervention 2: Single treatment,(saline) 20 IU/Intranasal (.1ml/10units intranasally in each nostril)

Protocol document: