Alzheimer's Disease Education and Referral Center

Study of Nasal Insulin to Fight Forgetfulness (SNIFF)

Study of Nasal Insulin to Fight Forgetfulness (SNIFF)

Overall Status: 
Active, not recruiting
Brief Description: 

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.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
55 Years
85 Years
Both
No
Inclusion Criteria: 
    • 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
Exclusion Criteria: 
    • 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
Detailed Description: 

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.

Central Contact Information: 

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

Locations: 
Map Marker CityStateZip CodePrimary Contact

Geolocation is 33.4636012, -112.0535987

Banner Alzheimer's Institute
Phoenix
Arizona
85006
Daniela Tauchmann
602-839-4891
daniela.tauchmann@bannerhealth.com

Geolocation is 33.5080943, -112.0863874

Barrow Neurological Institute
Phoeniz
Arizona
85013
Lazaro Martinez Lujan
602-406-7058
lazaro.martinezlujan@dignityhealth.org

Geolocation is 33.6471239, -117.8421325

University of California, Irvine
Irvine
California
92697
Beatriz Yanez
949-824-3250
byanez@uci.edu

Geolocation is 41.3052226, -72.9268626

Yale University School of Medicine
New Haven
Connecticut
06510
Hannah Michalak
203-764-8105
hannah.michalak@yale.edu

Geolocation is 38.9079086, -77.0716829

Georgetown University
Washington
District of Columbia
20057
Kelly Behan McCann
202-687-0413
keb53@georgetown.edu

Geolocation is 38.9178427, -77.0218255

Howard University
Washington
District of Columbia
20060
Oudolapo Ogunlana
202-865-1973
oogunlana@howard.edu

Geolocation is 30.2606613, -81.460856

Mayo Clinic
Jacksonville
Florida
32224
Kathleen Kiley
904-953-9456
kiley.kathleen@mayo.edu

Geolocation is 33.7980995, -84.3259367

Emory University
Atlanta
Georgia
30322
Erin Carter
404-712-6838
erin.carter@emory.edu

Geolocation is 41.8925085, -87.6161696

Northwestern University
Chicago
Illinois
60611
Kristine Lipowski
312-503-2486
k-lipowski@northwestern.edu

Geolocation is 41.9203468, -87.6433139

Rush University
Chicago
Illinois
60614
Rita Tharpe
312-563-4721
rita_tharpe@rush.edu

Geolocation is 39.7794767, -86.1700894

Indiana University
Indianapolis
Indiana
46202
Scott Herring
317-963-7418
sherring@iupui.edu

Geolocation is 38.0369642, -84.5379455

University of Kentucky
Lexington
Kentucky
40504
Hardin Stevens
859-323-2997
hardin.stevens@uky.edu

Geolocation is 39.2713976, -76.5603828

Johns Hopkins University
Baltimore
Maryland
21224
Sarah (Woody) Lawrence
410-550-9020
swoody1@jhmi.edu

Geolocation is 42.3476181, -71.1002881

Beth Israel Deaconess Medical Center
Boston
Massachusetts
02215
Jacqueline Fung
617-667-4194
jfung@bidmc.harvard.edu

Geolocation is 42.339904, -71.0898892

Brigham and Women's Hospital
Boston
Massachusetts
02115
Martha Vander Vliet
617-732-8085
mvandervliet@partners.org

Geolocation is 44.0557303, -92.5253639

Mayo Clinic
Rochester
Minnesota
55905
Ross Haller
507-293-4575
haller.ross@mayo.edu

Geolocation is 40.7916407, -73.9447994

Mount Sinai School of Medicine
New York
New York
10029
Jonathan "Yoni" Greenberg
212-659-5621
jonathan.greenberg@mssm.edu

Geolocation is 43.1301942, -77.6020569

University of Rochester Medical Center
Rochester
New York
14620
Susan Salem-Spencer
585-760-6562
susan_salem-spencer@urmc.rochester.edu

Geolocation is 36.0906568, -80.2715385

Wake Forest University Health Sciences
Winston-Salem
North Carolina
27157
Erin Caulder
336-713-8847
ecaulder@wakehealth.edu

Geolocation is 41.4766201, -81.5047772

Case Western Reserve University
Beachwood
Ohio
44122
Parianne Fatica
216-464-6474
parianne.fatica@uhhospitals.org

Geolocation is 41.816736, -71.4091563

Rhode Island Hospital
Providence
Rhode Island
02903
Michele Astphan
401-444-2484
mastphan@lifespan.org

Geolocation is 32.7791432, -79.9248669

Roper St. Francis Hospital
Charleston
South Carolina
29401
Allison Lapp
843-724-2214
allison.lapp@rsfh.com

Geolocation is 29.7050857, -95.4018087

Baylor College of Medicine
Houston
Texas
77030
Sydney O'Connor
713-798-8329
soconnor@bcm.edu

Geolocation is 36.142324, -95.956825

Tulsa Clinical Research
Tulsa
Oklahoma
74104
Duwane Tillery
918-743-2349
dtillery@tulsaclinicalresearch.com

Geolocation is 47.5405059, -122.3045438

University of Washington
Seattle
Washington
98108
Anita Ranta
206-764-2339
rantaa@uw.edu
Lead Sponsor: 
Agency
Wake Forest University
Collaborator Sponsor: 
Agency
University of Southern California, Alzheimer's Therapeutic Research Institute
Facility Investigators: 
NameRoleAffiliation
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
Study Contact: 
NamePhoneEmail
Karen Bowman
858-964-0828
Shelley Moore
858-964-0809
Locations
 
 
ClinicalTrials.gov ID 
NCT01767909 (follow link to view full record on ct.gov in new window)
Official Title: 
Therapeutic Effects of Intranasally-Administered Insulin in Adults With Amnestic Mild Cognitive Impairment (aMCI) or Mild Alzheimer's Disease (AD)
Study Start Date: 
September 2013
Study End Date: 
December 2018
Disease Stage: 
Early
Enrollment: 
240