Alzheimer's Disease Education and Referral Center

Intranasal Insulin in the Fight Against Forgetfulness (SNIFF)

Intranasal Insulin in the Fight Against Forgetfulness (SNIFF)

Overall Status: 
Temporarily suspended
Brief Description: 

This Phase II/III clinical trial will examine whether a type of insulin, when administered intranasally (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 (by Petersen criteria) or probable Alzheimer's disease (by National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association criteria)
    • 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 1 or type 2) requiring medication; current or past use of insulin or other diabetes medication
    • 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 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.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 33.4636012, -112.0535987

Site
Phoenix
Arizona
85006
Not yet recruiting
Name:
Phone:

Geolocation is 33.612697, -112.280129

Site
Sun City
Arizona
85351
Not yet recruiting
Name:
Phone:

Geolocation is 33.6471239, -117.8421325

Site
Irvine
California
92697
Recruiting
Name: Catherine McAdams-Ortiz, MSN, RN, A/GNP
Phone: 949-824-8726

Geolocation is 32.8328112, -117.2712717

Site
La Jolla
California
92037
Recruiting
Name: Kacie Smith, BA
Phone: 858-246-1303
Email: kts001@ucsd.edu

Geolocation is 41.3052226, -72.9268626

Site
New Haven
Connecticut
06510
Not yet recruiting
Name:
Phone:

Geolocation is 38.9079086, -77.0716829

Site
Washington
District of Columbia
20057
Not yet recruiting
Name:
Phone:

Geolocation is 38.9178427, -77.0218255

Site
Washington
District of Columbia
20060
Not yet recruiting
Name:
Phone:

Geolocation is 30.2606613, -81.460856

Site
Jacksonville
Florida
32224
Not yet recruiting
Name:
Phone:

Geolocation is 28.0869646, -82.4698603

Site
Tampa
Florida
33613
Recruiting
Name: Jill Smith, MA, CCRC
Phone: 813-974-4355
Email: jsmith10@health.usf.edu

Geolocation is 41.9214378, -87.6513043

Site
Chicago
Illinois
60614
Recruiting
Name: Lindsay Pluff
Phone: 312-563-4111
Email: lindsay_m_pluff@rush.edu

Geolocation is 41.8925085, -87.6161696

Site
Chicago
Illinois
60611
Recruiting
Name: Kristine Lipowski, BA
Phone: 312-503-2486
Email: k-lipowski@northwestern.edu

Geolocation is 39.7794767, -86.1700894

Site
Indianapolis
Indiana
46202
Not yet recruiting
Name:
Phone:

Geolocation is 39.0222277, -94.6319018

Site
Fairway
Kansas
66205
Recruiting
Name: Natalya Stolyar
Phone: 913-945-7676
Email: nstolyar@kumc.edu

Geolocation is 38.0369642, -84.5379455

Site
Lexington
Kentucky
40504
Recruiting
Name: Heather Nichols, BS
Phone: 859-323-3145
Email: hdnich2@email.uky.edu

Geolocation is 39.2713976, -76.5603828

Site
Baltimore
Maryland
21224
Not yet recruiting
Name:
Phone:

Geolocation is 42.339904, -71.0898892

Site
Boston
Massachusetts
02115
Not yet recruiting
Name:
Phone:

Geolocation is 44.0557303, -92.5253639

Site
Rochester
Minnesota
55905
Not yet recruiting
Name:
Phone:

Geolocation is 38.647459, -90.25731

Site
St. Louis
Missouri
63108
Not yet recruiting
Name: Joyce Haynie, RN, MSN
Phone: 314-286-2683
Email: hayniej@abraxas.wustl.edu

Geolocation is 40.7916407, -73.9447994

Site
New York
New York
10029
Not yet recruiting
Name:
Phone:

Geolocation is 40.74727, -73.9800645

Site
New York
New York
10016
Not yet recruiting
Name:
Phone:

Geolocation is 43.1301942, -77.6020569

Site
Rochester
New York
14620
Not yet recruiting
Name:
Phone:

Geolocation is 36.0906568, -80.2715385

Site
Winston-Salem
North Carolina
27157
Recruiting
Name: Erin Caulder, PhD
Phone: 336-713-8847
Email: ecaulder@wakehealth.edu

Geolocation is 41.4644979, -81.5087322

Site
Beachwood
Ohio
44122
Recruiting
Name: Parianne Fatica
Phone: 216-464-6474
Email: parianne.fatica@uhhospitals.org

Geolocation is 45.4874111, -122.6875541

Site
Portland
Oregon
97239
Recruiting
Name: Betty Lind, BS
Phone: 503-494-9399
Email: petriko@ohsu.edu

Geolocation is 41.816736, -71.4091563

Site
Providence
Rhode Island
02903
Recruiting
Name: Michele Astphan, RN
Phone: 401-444-2484
Email: mastphan@lifespan.org

Geolocation is 32.7791432, -79.9248669

Site
Charleston
South Carolina
29401
Not yet recruiting
Name:
Phone:

Geolocation is 32.8113367, -96.8397899

Site
Dallas
Texas
75390
Recruiting
Name: Gloria Williams, BA
Phone: 214-648-9331
Email: gloria.williams2@utsouthwestern.edu

Geolocation is 29.7050857, -95.4018087

Site
Houston
Texas
77030
Recruiting
Name: Lindsay Reid, BS
Phone: 713-798-4734
Email: lindsayr@bcm.edu

Geolocation is 47.5405059, -122.3045438

Site
Seattle
Washington
98108
Not yet recruiting
Name:
Phone:
Lead Sponsor: 
Agency
Alzheimer's Disease Cooperative Study (ADCS)
Collaborator Sponsor: 
Facility Investigators: 
NameRoleAffiliation
Suzanne Craft, PhD
Study Director
Wake Forest Univeristy School of Medicine
Study Contact: 
NamePhoneEmail
Jeffree Itrich
858-246-1317
Genny Matthews
858-246-1318
Locations
 
 
ClinicalTrials.gov ID 
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: 
February 2015
Disease Stage: 
Early
Enrollment: 
240