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Study of Nasal Insulin to Fight Forgetfulness (SNIFF)

Start: September 2013
End: December 2018
Enrollment: 240

What Is This Study About?

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.

Do I Qualify To Participate in This Study?

Minimum Age: 55 Years

Maximum Age: 85 Years

Must have:

  • 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

Must NOT have:

  • 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
 

Who Is the General Study Contact?

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

Study Contact
Karen Bowman
Shelley Moore

Need Help?

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?

Arizona
Banner Alzheimer's Institute
Phoenix, AZ 85006
Daniela Tauchmann
Barrow Neurological Institute
Phoeniz, AZ 85013
Lazaro Martinez Lujan
California
University of California, Irvine
Irvine, CA 92697
Beatriz Yanez
Connecticut
Yale University School of Medicine
New Haven, CT 06510
Hannah Michalak
District of Columbia
Georgetown University
Washington, DC 20057
Kelly Behan McCann
Howard University
Washington, DC 20060
Oudolapo Ogunlana
Florida
Mayo Clinic
Jacksonville, FL 32224
Kathleen Kiley
Georgia
Emory University
Atlanta, GA 30322
Erin Carter
Illinois
Northwestern University
Chicago, IL 60611
Kristine Lipowski
Rush University
Chicago, IL 60614
Rita Tharpe
Indiana
Indiana University
Indianapolis, IN 46202
Scott Herring
Kentucky
University of Kentucky
Lexington, KY 40504
Hardin Stevens
Maryland
Johns Hopkins University
Baltimore, MD 21224
Sarah (Woody) Lawrence
Massachusetts
Brigham and Women's Hospital
Boston, MA 02115
Martha Vander Vliet
Beth Israel Deaconess Medical Center
Boston, MA 02215
Jacqueline Fung
Minnesota
Mayo Clinic
Rochester, MN 55905
Ross Haller
New York
Mount Sinai School of Medicine
New York, NY 10029
Jonathan "Yoni" Greenberg
University of Rochester Medical Center
Rochester, NY 14620
Susan Salem-Spencer
North Carolina
Wake Forest University Health Sciences
Winston-Salem, NC 27157
Erin Caulder
Ohio
Case Western Reserve University
Beachwood, OH 44122
Parianne Fatica
Oklahoma
Tulsa Clinical Research
Tulsa, OK 74104
Duwane Tillery
Rhode Island
Rhode Island Hospital
Providence, RI 02903
Michele Astphan
South Carolina
Roper St. Francis Hospital
Charleston, SC 29401
Allison Lapp
Texas
Baylor College of Medicine
Houston, TX 77030
Sydney O'Connor
Washington
University of Washington
Seattle, WA 98108
Anita Ranta

Who Sponsors This Study?

Lead: Wake Forest University

Collaborator Sponsor

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

Source: ClinicalTrials.gov ID: NCT01767909