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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

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

Study Contact
Karen Bowman
858-964-0828
k.bowman@usc.edu

Shelley Moore
858-964-0809
shelleym@usc.edu

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Who Is the General Study Contact?

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

Where Is This Study Located?

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

Who Sponsors This Study?

Lead: Wake Forest University

Collaborator Sponsor

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

Source: ClinicalTrials.gov ID: NCT01767909