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SNIFF 120: Study of Nasal Insulin to Fight Forgetfulness (120 Days) (SNIFF 120)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Alzheimer's Disease Drug: Regular Insulin Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Effects of Intranasal Insulin Administration in AD
Study Start Date : June 2006
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: 1
saline
 Drug: Placebo
administered intra-nasally twice a day for 16 weeks
Other Name: saline
Experimental: 2
10 Units
 Drug: Regular Insulin
administered intra-nasally twice a day for 16 weeks
Other Name: Novolin U-100
Experimental: 3
20 Units
 Drug: Regular Insulin
administered intra-nasally twice a day for 16 weeks
Other Name: Novolin U-100


Outcome Measures
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Primary Outcome Measures :
  1. Changes in cognition [ Time Frame: every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks) ]
  2. glucose metabolism [ Time Frame: every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks) ]
  3. plasma biological markers [ Time Frame: every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks) ]

Secondary Outcome Measures :
  1. CSF biological markers [ Time Frame: every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks) ]
  2. cerebral glucose metabolism [ Time Frame: every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks) ]

Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00438568


Locations
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United States, Washington
Veterans Administration Puget Sound Health Care System
Seattle, Washington, United States, 98108
Sponsors and Collaborators
University of Washington
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Suzanne Craft, PhD University of Washington
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT00438568    
Other Study ID Numbers: 30579-B
5R01AG027415 ( U.S. NIH Grant/Contract )
1R01AG027415-01 ( U.S. NIH Grant/Contract )
First Posted: February 22, 2007    Key Record Dates
Last Update Posted: September 14, 2012
Last Verified: September 2012
Keywords provided by University of Washington:
amyloid protein
brain metabolism
glucose metabolism
insulin sensitivity /resistance
cognition disorders
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
 Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs