Trial record 1 of 3 for:    SNIFF-120
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SNIFF 120: Study of Nasal Insulin to Fight Forgetfulness (120 Days)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00438568
First received: February 21, 2007
Last updated: September 12, 2012
Last verified: September 2012

February 21, 2007
September 12, 2012
June 2006
December 2011   (final data collection date for primary outcome measure)
  • Changes in cognition [ Time Frame: every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks) ] [ Designated as safety issue: No ]
  • glucose metabolism [ Time Frame: every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks) ] [ Designated as safety issue: No ]
  • plasma biological markers [ Time Frame: every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks) ] [ Designated as safety issue: No ]
  • Changes in cognition
  • glucose metabolism
  • plasma biological markers
Complete list of historical versions of study NCT00438568 on ClinicalTrials.gov Archive Site
  • CSF biological markers [ Time Frame: every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks) ] [ Designated as safety issue: No ]
  • cerebral glucose metabolism [ Time Frame: every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks) ] [ Designated as safety issue: No ]
  • CSF biological markers
  • cerebral glucose metabolism
Not Provided
Not Provided
 
SNIFF 120: Study of Nasal Insulin to Fight Forgetfulness (120 Days)
Therapeutic Effects of Intranasal Insulin Administration in AD

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Mild Cognitive Impairment
  • Alzheimer's Disease
  • 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
  • Placebo Comparator: 1
    saline
    Intervention: Drug: Placebo
  • Experimental: 2
    10 Units
    Intervention: Drug: Regular Insulin
  • Experimental: 3
    20 Units
    Intervention: Drug: Regular Insulin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
173
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00438568
30579-B, 5R01AG027415, 1R01AG027415-01
Yes
University of Washington
University of Washington
National Institute on Aging (NIA)
Principal Investigator: Suzanne Craft, PhD University of Washington
University of Washington
September 2012

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