Start: July 16, 2020
End: October 2023
What Is This Study About?
Growing evidence suggests that insulin affects normal memory processes and that abnormal insulin levels may contribute to cognitive and brain changes associated with Alzheimer's disease. The Study of Nasal Insulin to Fight Forgetfulness (SNIFF) will test devices that deliver insulin through the nose, and the effects of insulin on memory and insulin levels in the blood and cerebrospinal fluid. Participants will be randomized to receive either 20 or 40 units of insulin, delivered through the nose, over two study visits. Researchers will measure changes in memory, biomarkers for Alzheimer's disease, and insulin levels in the blood and cerebrospinal fluid.
Do I Qualify To Participate in This Study?
- Fluent in English
- Cognitively normal or diagnosis of amnestic mild cognitive impairment
- Medical conditions stable for three months prior to screening visit
- Medications stable for four weeks prior to the screening and study visits
- Laboratory test values within normal limits or, if abnormal, must be clinically insignificant
Must NOT have:
- Diagnosis of dementia
- History of stroke
- Current evidence or history in past two years of epilepsy, head injury with loss of consciousness, any major psychiatric disorder including psychosis, major depression, or bipolar disorder
- Diagnosis of diabetes (type 1 or type 2)
- Current or past regular use of insulin or any other medications to treat diabetes within two months of screening visit
- History of seizure within past five years
- Pregnancy or possible pregnancy
- Use of anticoagulants, such as warfarin (Coumadin) or dabigatran (Pradaxa)
- Residence in a skilled nursing facility at screening
- Use of any other study drug or device within two months of screening visit
- Regular use of alcohol, narcotics, anticonvulsants, or anti-parkinsonian medications
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
Lead: Wake Forest University Health Sciences
Source: ClinicalTrials.gov ID: NCT04199767