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

This study has been completed.
Sponsor:
Collaborator:
National Institute on Aging (NIA)
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
History of Changes
  Purpose

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 Intervention Phase
Mild Cognitive Impairment
Alzheimer's Disease
 Drug: Regular Insulin
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Effects of Intranasal Insulin Administration in AD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 173
Study Start Date: June 2006
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00438568

Locations
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
Principal Investigator: Suzanne Craft, PhD University of Washington
  More Information

Additional Information:
The Memory Wellness Program, University of Washington and VA Puget Sound Health Care System, www.memorywellness.org  This link exits the ClinicalTrials.gov site

Publications:

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

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT00438568     History of Changes
Other Study ID Numbers: 30579-B, 5R01AG027415, 1R01AG027415-01
Study First Received: February 21, 2007
Last Updated: September 12, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Washington:
amyloid protein
brain metabolism
glucose metabolism
insulin sensitivity /resistance
cognition disorders

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
 Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013