Trial intelligence / Profile preview

Intranasal Glulisine in Mild-Moderate Alzheimer's Disease

NCT01436045Phase 2

Key facts

Status
Completed
Start
Sep 2011
Primary completion
Jun 2013
Countries
1
Sponsor
HealthPartners Institute
Modality
Peptides
Conditions
Alzheimer's disease (AD)
01

Overview

Phase 2, randomised, double-blind trial of insulin glulisine in Alzheimer's disease (AD) (2 arms), sponsored by HealthPartners Institute. Primary endpoints: Cognitive Performance, Trail Making Test Part B - Seconds and 1 more. Started Sep 2011; status: completed.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Insulin glulisine

    Intranasal insulin glulisine 20 IU

  • Saline

    Intranasal saline placebo

03

Who it enrols

Patients aged 65-85 with probable mild-moderate Alzheimer's Disease (MMSE 18-26, CDR 1-2) on stable AChEI or memantine. Excludes diabetes, heavy smoking, and other significant CNS or psychiatric disorders.

04

Endpoints

Primary

  • Cognitive Performance

  • Trail Making Test Part B - Seconds

  • Trail Making Test Part B - Errors

Secondary

  • Olfactory Function

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