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Trial record 1 of 1 for:    SNIFF-120
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SNIFF 120: Study of Nasal Insulin to Fight Forgetfulness (120 Days) (SNIFF 120)

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ClinicalTrials.gov Identifier: NCT00438568
Recruitment Status : Completed
First Posted : February 22, 2007
Last Update Posted : September 14, 2012
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Washington

Tracking Information
First Submitted Date  ICMJE February 21, 2007
First Posted Date  ICMJE February 22, 2007
Last Update Posted Date September 14, 2012
Study Start Date  ICMJE June 2006
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
  • Changes in cognition [ Time Frame: every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks) ]
  • glucose metabolism [ Time Frame: every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks) ]
  • plasma biological markers [ Time Frame: every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks) ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 21, 2007)
  • Changes in cognition
  • glucose metabolism
  • plasma biological markers
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
  • CSF biological markers [ Time Frame: every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks) ]
  • cerebral glucose metabolism [ Time Frame: every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2007)
  • CSF biological markers
  • cerebral glucose metabolism
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SNIFF 120: Study of Nasal Insulin to Fight Forgetfulness (120 Days)
Official Title  ICMJE Therapeutic Effects of Intranasal Insulin Administration in AD
Brief Summary The purpose of this study is to find out if insulin, when administered as a "nasal spray" into the nasal passages, improves memory in adults with mild cognitive impairment (MCI) or Alzheimer's disease.
Detailed Description

A growing body of evidence suggests that insulin plays a role in normal memory processes and that insulin abnormalities may contribute to cognitive and brain changes associated with Alzheimer's disease (AD). Interestingly, insulin administered to the nasal cavity is transported within a few minutes into the brain, but does not affect blood sugar or insulin levels.

This study will consist of a randomized double-blind, placebo-controlled parallel group trial in which 90 participants with AD or MCI receive daily intranasal administrations of either insulin (10 or 20 IU twice a day for a total dose of 20 or 40 IU per day) or placebo (saline twice a day) for 4 months. The study will examine the effects of intranasal insulin administration on cognition, cerebral glucose metabolism, and β-amyloid (Aβ) in cerebrospinal fluid (CSF) and plasma, testing the hypothesis that daily intranasal insulin administration for 4 months will facilitate memory for adults with AD, and adults with mild cognitive impairment (MCI). A subset of participants will have the option to participate in 2 sub-studies: PET scans (prior to and at the end of treatment) to determine whether intranasal insulin increases cerebral glucose metabolism; lumbar punctures (LPs) before and at the end of treatment to determine effects of intranasal insulin administration on CSF Aβ levels.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Mild Cognitive Impairment
  • Alzheimer's Disease
Intervention  ICMJE
  • Drug: Regular Insulin
    administered intra-nasally twice a day for 16 weeks
    Other Name: Novolin U-100
  • Drug: Placebo
    administered intra-nasally twice a day for 16 weeks
    Other Name: saline
Study Arms  ICMJE
  • Placebo Comparator: 1
    saline
    Intervention: Drug: Placebo
  • Experimental: 2
    10 Units
    Intervention: Drug: Regular Insulin
  • Experimental: 3
    20 Units
    Intervention: Drug: Regular Insulin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 3, 2009)
173
Original Enrollment  ICMJE
 (submitted: February 21, 2007)
90
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 55 or greater
  • Good physical health
  • Memory impairment with a diagnosis of mild cognitive impairment (MCI) or Alzheimer's disease (AD)
  • Participants on stable doses of Memantine (Namenda) or cholinesterase inhibitors will be eligible

Exclusion Criteria:

  • Chronic sinus problems/allergies with chronic use of nasal decongestants or antihistamines
  • Significant neurologic disease that might affect cognition (other than AD), such as stroke, Parkinson's disease, multiple sclerosis, severe head injury with loss of consciousness for more than 30 minutes or with permanent neurologic symptoms
  • Significant medical illness or organ failure, such as uncontrolled hypertension or cardiovascular disease, chronic obstructive pulmonary disease, liver disease, or kidney disease
  • Preexisting diabetes or current or previous use of hypoglycemic agents or insulin; participants will be excluded if they have a fasting blood sugar greater than 165 on baseline OGTT
  • Clinically significant elevations in liver function tests, cholesterol, or triglycerides
  • Major psychiatric disorders (e.g., untreated major depression and schizophrenia)
  • Chronic use of the following types of medications: anti-psychotic, anxiolytic, and opiates
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00438568
Other Study ID Numbers  ICMJE 30579-B
5R01AG027415 ( U.S. NIH Grant/Contract )
1R01AG027415-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Suzanne Craft, PhD University of Washington
PRS Account University of Washington
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP