Study of Nasal Insulin to Fight Forgetfulness - Long-acting Insulin Detemir - 120 Days (SL120)

Completed · Phase 2

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 the 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 study in which participants will receive insulin detemir, regular insulin, or placebo over a four month period. The investigators will test the hypothesis that insulin and insulin detemir will both improve memory and daily functioning in persons with AD/aMCI compared with placebo, but that insulin detemir will have the greatest effect.

Key facts

Study ID

NCT01595646

Run by

Wake Forest University Health Sciences

People needed

37

Starts

2011-11-01

Expected to finish

2015-03-12

Last updated by the study team

2020-11-17

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
• Pre-existing diabetes not controlled by exercise/diet
• 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

• Wake Forest Baptist Hospital — Winston-Salem, North Carolina, United States
• VA Puget Sound Health Care System - American Lake Division — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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