Study of Nasal Insulin to Fight Forgetfulness - Long-acting Insulin Detemir - 21 Days

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease, Mild Cognitive Impairment

In brief

The study will examine the effects of intranasally administered long-acting insulin detemir on cognition in persons with Alzheimer's disease (AD) or amnestic mild cognitive impairment (aMCI). The rationale for these studies is derived from growing evidence that insulin contributes to multiple brain functions, and that insulin dysregulation can contribute to AD pathogenesis. Thus, therapies aimed at restoring normal insulin signaling in the CNS may have beneficial effects on brain function. Intranasal administration of insulin increases insulin signaling in brain without raising peripheral levels and causing hypoglycemia. Insulin detemir is an insulin analogue that may have better action in brain than other insulin formulations because of its albumin binding properties. The investigators will test the therapeutic effects of intranasally-administered insulin detemir in a dose-finding study in which participants will receive one of two doses of insulin detemir or placebo for a three week period. The investigators will test the hypothesis that either dose will improve memory and daily functioning in persons with AD/aMCI compared with placebo.

Key facts

Study ID

NCT01547169

Run by

University of Washington

People needed

60

Starts

2011-03-01

Expected to finish

2012-12-01

Last updated by the study team

2012-12-18

Who can join

Age: 50 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 50-89
• Diagnosed with mild cognitive impairment, or mild/moderate AD

You may not qualify if…

• Excessively high or low blood pressure, heart rate
• BMI greater than 34
• Pre-existing diabetes not controlled by exercise
• Previous/current use of insulin
• Significant elevations in lipids, liver enzymes
• Menstrual period within the last 12 months
• Significant neurological or medical disorder (other than AD)
• Significant use of nasal decongestants
• Current use of anti-psychotic, anti-convulsive, anxiolytic, glucocorticoids, or sedative medications

Where it is running

• VA Puget Sound Health Care System — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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