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

September 12, 2012 updated by: University of Washington

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

173

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98108
        • Veterans Administration Puget Sound Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
saline
Drug: Placebo
administered intra-nasally twice a day for 16 weeks
Other Names:
  • saline
Experimental: 2
10 Units
Drug: Regular Insulin
administered intra-nasally twice a day for 16 weeks
Other Names:
  • Novolin U-100
Experimental: 3
20 Units
Drug: Regular Insulin
administered intra-nasally twice a day for 16 weeks
Other Names:
  • Novolin U-100

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in cognition
Time Frame: every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks)
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)
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)
every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
CSF biological markers
Time Frame: every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks)
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)
every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Suzanne Craft, PhD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

February 21, 2007

First Submitted That Met QC Criteria

February 21, 2007

First Posted (Estimate)

February 22, 2007

Study Record Updates

Last Update Posted (Estimate)

September 14, 2012

Last Update Submitted That Met QC Criteria

September 12, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30579-B
  • 5R01AG027415 (U.S. NIH Grant/Contract)
  • 1R01AG027415-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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