Skip to main content

Study of Nasal Insulin to Fight Forgetfulness (SNIFF)

  • Active, not recruiting

This Phase II/III clinical trial will examine whether a type of insulin, when administered as a nasal spray, improves memory in adults with a mild cognitive impairment or Alzheimer’s disease. The study will also provide evidence about how intranasal insulin works in the body.

Minimum Age Maximum Age Gender Healthy Volunteers
55 Years 85 Years Both No
September 2013
December 2018
240
  • Diagnosis of amnestic MCI or probable mild Alzheimer's disease, according to the core clinical criteria outlined in the NIA and Alzheimer's Association guidelines
  • Mini-Mental State Examination (MMSE) score of 20 or higher at screening; Clinical Dementia Rating of 0.5-1 at screening; Logical Memory score of 8 or lower for 16 or more years of education, 4 or lower for 8-15 years of education, 2 or lower for 0-7 years of education
  • Modified Hachinski score of less than or equal to 4
  • Study partner able to accompany the participant to most visits and answer questions about the participant; partner must have direct contact with the participant more than 2 days per week (minimum of 10 hours per week) and supervise drug administration as needed
  • Stable medical condition for 3 months prior to screening
  • Stable medications for 4 weeks prior to screening and baseline visits
  • At least 6 years of education or work history
  • Clinical laboratory values must be within normal limits or, if abnormal, must be judged to be clinically insignificant by the investigator
  • Adequate seeing and hearing ability to complete neuropsychological testing
  • Fluency in English or Spanish
  • Diagnosis of dementia other than probable Alzheimer's disease
  • Probable Alzheimer's with Down syndrome
  • History of clinically significant stroke
  • Current evidence or history in past 2 years of epilepsy, focal brain lesion, or head injury with loss of consciousness
  • Major psychiatric disorder, including psychosis, major depression, bipolar disorder, or alcohol or substance abuse
  • Sensory impairment that precludes participation in the study
  • Diabetes (type I or II) requiring pharmacologic treatment (including both insulin-dependent and non-insulin dependent diabetes mellitus)
  • Clinically significant or unstable hematologic, hepatic, cardiovascular, pulmonary, endocrine, metabolic, renal, or other systemic disease or laboratory abnormality
  • Active neoplastic disease
  • History of cancer in 5 years prior to screening (history of skin melanoma or stable prostate cancer are allowable)
  • Seizure within the past 5 years
  • Other significant clinical disorder or laboratory finding that renders the participant unsuitable for receiving intranasal insulin
  • Pregnancy or possible pregnancy
  • Contraindication to lumbar puncture, such as prior lumbosacral spine surgery, severe degenerative joint disease, or deformity of the spine
  • Platelet count of less than 100,000 or history of bleeding disorder
  • Use of anticoagulants warfarin (Coumadin) or dabigatran (Pradaxa)
  • Contraindication to magnetic resonance imaging, such as claustrophobia, craniofacial metal implant of any kind, or pacemaker
  • Residence in a skilled nursing facility at screening
  • Use of an investigational agent within 2 months of screening visit
  • Regular use of narcotics, anticonvulsants, medications with significant anticholinergic activity, or antiparkinsonian medications

Growing evidence has shown that insulin, a naturally occurring hormone, carries out multiple functions in the brain, and that insulin dysregulation may contribute to the development of Alzheimer's disease. This study will examine the effects of intranasally administered insulin on cognition, entorhinal cortex and hippocampal atrophy (shrinkage), and cerebrospinal fluid biomarkers in people with amnestic MCI or mild Alzheimer's.

In this study, 240-300 people with amnestic MCI or mild Alzheimer's will be given either intranasal insulin or a placebo for 12 months, following 6 months during which all participants will take the active drug. The study uses intranasal administration focusing on nose-to-brain transport as a mode of delivery. Researchers predict that after 12 months of treatment, participants who take intranasal insulin will improve their cognitive performance compared with those who take a placebo. The study also will examine whether an initial Alzheimer's disease biomarker profile, gender, or APOE ε4 allele status can predict treatment response.

For more information on this trial, contact sniff-participate@usc.edu.

Name City State Zip Status Primary Contact
Banner Alzheimer's Institute Phoenix Arizona 85006 Daniela Tauchmann
602-839-4891
daniela.tauchmann@bannerhealth.com
University of California, Irvine Irvine California 92697 Beatriz Yanez
949-824-3250
byanez@uci.edu
Yale University School of Medicine New Haven Connecticut 06510 Hannah Michalak
203-764-8105
hannah.michalak@yale.edu
Georgetown University Washington District of Columbia 20057 Kelly Behan McCann
202-687-0413
keb53@georgetown.edu
Howard University Washington District of Columbia 20060 Oudolapo Ogunlana
202-865-1973
oogunlana@howard.edu
Mayo Clinic Jacksonville Florida 32224 Kathleen Kiley
904-953-9456
kiley.kathleen@mayo.edu
Northwestern University Chicago Illinois 60611 Kristine Lipowski
312-503-2486
k-lipowski@northwestern.edu
Rush University Chicago Illinois 60614 Rita Tharpe
312-563-4721
rita_tharpe@rush.edu
Indiana University Indianapolis Indiana 46202 Scott Herring
317-963-7418
sherring@iupui.edu
University of Kentucky Lexington Kentucky 40504 Hardin Stevens
859-323-2997
hardin.stevens@uky.edu
Johns Hopkins University Baltimore Maryland 21224 Sarah (Woody) Lawrence
410-550-9020
swoody1@jhmi.edu
Brigham and Women's Hospital Boston Massachusetts 02115 Martha Vander Vliet
617-732-8085
mvandervliet@partners.org
Mayo Clinic Rochester Minnesota 55905 Ross Haller
507-293-4575
haller.ross@mayo.edu
Mount Sinai School of Medicine New York New York 10029 Jonathan "Yoni" Greenberg
212-659-5621
jonathan.greenberg@mssm.edu
University of Rochester Medical Center Rochester New York 14620 Susan Salem-Spencer
585-760-6562
susan_salem-spencer@urmc.rochester.edu
Wake Forest University Health Sciences Winston-Salem North Carolina 27157 Erin Caulder
336-713-8847
ecaulder@wakehealth.edu
Case Western Reserve University Beachwood Ohio 44122 Parianne Fatica
216-464-6474
parianne.fatica@uhhospitals.org
Rhode Island Hospital Providence Rhode Island 02903 Michele Astphan
401-444-2484
mastphan@lifespan.org
Roper St. Francis Hospital Charleston South Carolina 29401 Allison Lapp
843-724-2214
allison.lapp@rsfh.com
Baylor College of Medicine Houston Texas 77030 Sydney O'Connor
713-798-8329
soconnor@bcm.edu
University of Washington Seattle Washington 98108 Anita Ranta
206-764-2339
rantaa@uw.edu
Tulsa Clinical Research Tulsa Oklahoma 74104 Duwane Tillery
918-743-2349
dtillery@tulsaclinicalresearch.com
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 Jacqueline Fung
617-667-4194
jfung@bidmc.harvard.edu
Barrow Neurological Institute Phoeniz Arizona 85013 Lazaro Martinez Lujan
602-406-7058
lazaro.martinezlujan@dignityhealth.org
Emory University Atlanta Georgia 30322 Erin Carter
404-712-6838
erin.carter@emory.edu

Wake Forest University

  • University of Southern California, Alzheimer's Therapeutic Research Institute -

Name Role Affiliation
Suzanne Craft, PhD Study Director Wake Forest University School of Medicine
Paul Aisen, MD Study Director University of Southern California, Alzheimer's Therapeutic Research Institute

Name Phone Extension Email
Karen Bowman 858-964-0828 k.bowman@usc.edu
Shelley Moore 858-964-0809 shelleym@usc.edu

Therapeutic Effects of Intranasally-Administered Insulin in Adults With Amnestic Mild Cognitive Impairment (aMCI) or Mild Alzheimer`s Disease (AD)