The Study of Nasal Insulin in the Fight Against Forgetfulness (SNIFF)



Status:Completed
Conditions:Alzheimer Disease, Cognitive Studies
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:55 - 85
Updated:1/20/2019
Start Date:January 8, 2014
End Date:December 11, 2018

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

An urgent need exists to find effective treatments for Alzheimer's disease (AD) that can
arrest or reverse the disease at its earliest stages. The emotional and financial burden of
AD to patients, family members, and society is enormous, and is predicted to grow
exponentially as the median population age increases. Current FDA-approved therapies are
modestly effective at best. This study will examine a novel therapeutic approach using
intranasal insulin (INI) that has shown promise in short-term clinical trials. If successful,
information gained from the study has the potential to move INI forward rapidly as a therapy
for AD. The study will also provide evidence for the mechanisms through which INI may produce
benefits by examining key cerebral spinal fluid (CSF) biomarkers and hippocampal/entorhinal
atrophy. These results will have considerable clinical and scientific significance, and
provide therapeutically-relevant knowledge about insulin's effects on AD pathophysiology.
Growing evidence has shown that insulin carries out multiple functions in the brain, and that
insulin dysregulation may contribute to AD pathogenesis.

This study will examine the effects of intranasally-administered insulin on cognition,
entorhinal cortex and hippocampal atrophy, and cerebrospinal fluid (CSF) biomarkers in
amnestic mild cognitive impairment (aMCI) or mild AD. It is hypothesized that after 12 months
of treatment with INI compared to placebo, subjects will improve performance on a global
measure of cognition, on a memory composite and on daily function. In addition to the
examination of CSF biomarkers and hippocampal and entorhinal atrophy, the study aims to
examine whether baseline AD biomarker profile, gender, or Apolipoprotein epsilon 4 (APOE-ε4)
allele carriage predict treatment response.

In this study, 240 people with aMCI or AD will be given either INI or placebo for 12 months,
following an open-label period of 6 months where all participants will be given active drug.
The study uses insulin as a therapeutic agent and intranasal administration focusing on nose
to brain transport as a mode of delivery.


Inclusion Criteria:

- Fluent in English or Spanish

- Diagnosis of aMCI by Petersen criteria or probable AD by National Institute of
Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related
Disorders Association (NINCDS-ADRDA) criteria

- Mini Mental State Examination (MMSE) score at screening is greater than or equal to 20

- Clinical Dementia Rating is 0.5-1 at screening

- Logical Memory is less than or equal to 8 for 16 or more years of education, less than
or equal to 4 for 8-15 years of education, less than or equal to 2 for 0-7 years of
education. Scores measured at screening on Delayed Paragraph Recall (Paragraph A only)
from the Wechsler Memory Scale-Revised

- Able to complete baseline assessments

- Modified Hachinski score of less than or equal to 4

- A study partner able to accompany the participant to most visits and answer questions
about the participant

- The study partner must have direct contact with the participant more than 2 days per
week (minimum of 10 hours per week) and provide supervision of drug administration as
needed

- Stable medical condition for 3 months prior to screening visit

- Stable medications for 4 weeks prior to the screening and baseline visits

- Stable use of permitted medications

- At least six 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

- Visual and auditory acuity adequate for neuropsychological testing

Exclusion Criteria:

- A diagnosis of dementia other than probable AD

- Probable AD with Down syndrome

- History of clinically significant stroke

- Current evidence or history in past two years of epilepsy, focal brain lesion, head
injury with loss of consciousness or Diagnostic and Statistical Manual of Mental
Disorders, Fourth Edition (DSM IV) criteria for any major psychiatric disorder
including psychosis, major depression, bipolar disorder, alcohol or substance abuse

- Sensory impairment that would preclude the participant from participating in or
cooperating with the protocol

- Diabetes (type 1 or type II) requiring pharmacologic treatment (including both insulin
dependent and non-insulin dependent diabetes mellitus)

- Current or past use of insulin or any other anti-diabetic medication

- Evidence of any significant clinical disorder or laboratory finding that renders the
participant unsuitable for receiving investigational drug including clinically
significant or unstable hematologic, hepatic, cardiovascular, pulmonary, endocrine,
metabolic, renal or other systemic disease or laboratory abnormality.

- Active neoplastic disease, history of cancer five years prior to screening (history of
skin melanoma or stable prostate cancer are not excluded)

- History of seizure within the past five years

- Pregnancy or possible pregnancy

- Contraindications to Lumbar Puncture (LP) procedure: prior lumbosacral spine surgery,
severe degenerative joint disease or deformity of the spine, platelets is less than
100,000 or history of bleeding disorder

- Use of anticoagulants warfarin (Coumadin) and dabigatran (Pradaxa) due to LP
requirement

- Contraindications for MRI (claustrophobia, craniofacial metal implants of any kind,
pacemakers)

- Residence in a skilled nursing facility at screening

- Use of an investigational agent within two months or screening visit

- Regular use of narcotics, anticonvulsants, medications with significant
anticholinergic activity, antiparkinsonian medications or any other exclusionary
medications
We found this trial at
25
sites
593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Principal Investigator: Brian Ott, MD
Phone: 401-444-2484
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Providence, RI
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Allan Levey, MD, PhD
Phone: 404-712-6838
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Esther Oh, MD
Phone: 410-550-9020
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Scott McGinnis, MD
Phone: 617-732-8085
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Henry Querfurth, MD, PhD
Phone: 617-667-4194
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Joseph Kass, MD, JD
Phone: 713-798-8329
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Houston, TX
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Jared Brosch, MD
Phone: 317-963-7418
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Principal Investigator: Anton Porsteinsson, MD
Phone: 585-760-6562
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Rochester, NY
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Beachwood, Ohio 44122
Principal Investigator: Alan Lerner, MD
Phone: 216-464-6474
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Beachwood, OH
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Charleston, South Carolina 29401
Principal Investigator: Jacobo Mintzer, MD, MBA
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Charleston, SC
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Marek-Marsel Mesulam, MD
Phone: 312-503-2486
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Chicago, IL
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Neelum Aggarwal, MD
Phone: 312-563-4721
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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Irvine, California 92697
949-824-5011
Principal Investigator: Aimee L Pierce, MD
Phone: 949-824-3250
University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
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Irvine, CA
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Jacksonville, Florida 32216
Principal Investigator: Neill Graff-Radford, MD
Phone: 904-953-8014
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Jacksonville, FL
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Lexington, Kentucky
859) 257-9000
Principal Investigator: Gregory Jicha, MD, PhD
Phone: 859-323-2997
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Lexington, KY
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Principal Investigator: Christopher van Dyck, MD
Phone: 203-764-8105
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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New Haven, CT
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New York, New York 10029
Principal Investigator: Hillel Grossman, MD
Phone: 212-659-5621
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New York, NY
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Phoenix, Arizona 85006
Principal Investigator: Allison Perrin, MD
Phone: 602-839-6924
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Phoenix, Arizona 85013
Principal Investigator: Marwan Sabbagh, MD
Phone: 602-406-7058
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Principal Investigator: David Knopman, MD
Phone: 507-284-4602
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Rochester, MN
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Seattle, Washington 98108
Principal Investigator: Elaine Peskind, MD
Phone: 206-764-2339
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Seattle, WA
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Tulsa, Oklahoma 74104
Principal Investigator: Ralph Richter, MD
Phone: 918-743-2349
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Tulsa, OK
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Washington, District of Columbia 20060
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3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Principal Investigator: Laura Baker, PhD
Phone: 336-713-5953
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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Winston-Salem, NC
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