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

Primary Purpose

Mild Cognitive Impairment, Alzheimer's Disease

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Regular Insulin

Placebo

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring amyloid protein, brain metabolism, glucose metabolism, insulin sensitivity /resistance, cognition disorders

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Veterans Administration Puget Sound Health Care System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm Description

saline

10 Units

20 Units

Outcomes

Primary Outcome Measures

Changes in cognition

glucose metabolism

plasma biological markers

Secondary Outcome Measures

CSF biological markers

cerebral glucose metabolism

Full Information

NCT ID

NCT00438568

First Posted

February 21, 2007

Last Updated

September 12, 2012

Sponsor

University of Washington

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT00438568

Brief Title

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

Acronym

SNIFF 120

Official Title

Therapeutic Effects of Intranasal Insulin Administration in AD

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

June 2006 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Washington

Collaborators

National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment, Alzheimer's Disease

Keywords

amyloid protein, brain metabolism, glucose metabolism, insulin sensitivity /resistance, cognition disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

173 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

saline

Arm Title

Arm Type

Experimental

Arm Description

10 Units

Arm Title

Arm Type

Experimental

Arm Description

20 Units

Intervention Type

Drug

Intervention Name(s)

Regular Insulin

Other Intervention Name(s)

Novolin U-100

Intervention Description

administered intra-nasally twice a day for 16 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

saline

Intervention Description

administered intra-nasally twice a day for 16 weeks

Primary Outcome Measure Information:

Title

Changes in cognition

Time Frame