Jun 13, 2012

Study of Nasal Insulin to Fight Forgetfulness (Clinical Trial)

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).

By Bob DeMarco
Alzheimer's Reading Room

For Your Information
I know many of you are interested in insulin and its possible effect on Alzheimer's.

Currently, there is an ongoing Phase 2 clinical trial to study the effects of intranasally administered long-acting insulin detemir on cognition in persons with Alzheimer's disease.

Phase 2 clinical trials are small, and generally they take place in a limited number of locations. In this case in Seattle and Tacoma, Washington.

It is often difficult to find qualified candidates for clinical trials into Alzheimer's disease. As a result, I would encourage anyone located in the Seattle or Tacoma areas to consider this trial. We do have a large number of readers in Washington state.


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Purpose

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.

Eligibility

Ages Eligible for Study: 50 Years to 89 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria
Inclusion Criteria:
  • Age 50-89
  • Diagnosed with mild cognitive impairment, or mild/moderate AD
Exclusion Criteria:
  • 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

Locations
United States, Washington
VA Puget Sound Health Care System - Seattle Division Recruiting
Seattle, Washington, United States, 98108
Contact: Selena Corbett 888-291-7316

VA Puget Sound Health Care System - American Lake Division Recruiting
Tacoma, Washington, United States, 98493
Contact: Kaysha Bowton 866-638-8813

Go here for additional details and description of the study -- Study of Nasal Insulin to Fight Forgetfulness - Long-acting Insulin Detemir - 120 Days (SL120)

More Insight and Advice for Caregivers

Original content Bob DeMarco, the Alzheimer's Reading Room