Nasal Insulin to Fight Forgetfulness-Long-acting Insulin Detemir-120 Days (SL120)
Nasal Insulin to Fight Forgetfulness-Long-acting Insulin Detemir-120 Days (SL120)
Overall Status:
No longer recruiting
Brief Description:
The study will examine the effects of intranasally administered long-acting insulin detemir on cognition in people with Alzheimer's disease or amnestic mild cognitive impairment (aMCI).
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
50 Years | 89 Years | Both | No |
Inclusion Criteria:
- Age 50-89
- Diagnosed with mild/moderate Alzheimer's disease or MCI
Exclusion Criteria:
- Excessively high or low blood pressure, heart rate
- Pre-existing diabetes not controlled by exercise/diet
- Significant elevations in lipids, liver enzymes
- Menstrual period within the last 12 months
- Significant neurological or medical disorder other than Alzheimer's disease
- Prohibited medications: Previous or current use of insulin, significant use of nasal decongestants, current use of antipsychotic, anticonvulsive, anxiolytic, glucocorticoids, or sedative medications
Detailed Description:
There is growing evidence that insulin contributes to multiple brain functions and that insulin dysregulation can contribute to Alzheimer's disease pathogenesis. Therapies aimed at restoring normal insulin signaling in the central nervous system may have beneficial effects on brain function. Intranasal administration of insulin increases insulin signaling in the brain without raising peripheral levels and causing hypoglycemia (abnormally low blood sugar).
Insulin detemir is an insulin analogue that may have better action in the brain than other insulin formulations because of its albumin-binding properties. Participants will receive insulin detemir, regular insulin, or placebo over a 4-month period. The investigators will test the hypothesis that insulin and insulin detemir will both improve memory and daily functioning in people with Alzheimer's or MCI compared with placebo, but that insulin detemir will have the greatest effect.
Locations:
| Map Marker | City | State | Zip Code |
|---|---|---|---|
Geolocation is 47.2528139, -122.4443415 | Tacoma | Washington | 98493 |
Lead Sponsor:
| Agency |
|---|
University of Washington |
Collaborator Sponsor:
| Agency |
|---|
Alzheimer's Association |
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Suzanne Craft, PhD | Principal Investigator | VA Puget Sound HCS/University of Washington School of Medicine |
Study Contact:
| Name | Phone |
|---|---|
Julie Moorer, RN | 253-583-2008 |
Locations
ClinicalTrials.gov ID
NCT01595646 (follow link to view full record on ct.gov in new window)
Official Title:
Study of Nasal Insulin to Fight Forgetfulness-Long-acting Insulin Detemir-120 Days (SL120)
Study Start Date:
November 2011
Study End Date:
March 2013
Disease Stage:
Early
Middle
Enrollment:
90
