SNIFF 120: Study of Nasal Insulin to Fight Forgetfulness (120 Days) - Full Text View

Sponsor:	National Institute on Aging (NIA)
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00438568

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Therapeutic Effects of Intranasal Insulin Administration in AD

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Insulin

U.S. FDA Resources

Further study details as provided by National Institute on Aging (NIA):

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 ]

Estimated Enrollment:	90
Study Start Date:	September 2006
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator saline	Drug: Placebo administered intra-nasally twice a day for 16 weeks
2: Experimental 10 Units	Drug: Regular Insulin administered intra-nasally twice a day for 16 weeks
3: Experimental 20 Units	Drug: Regular Insulin administered intra-nasally twice a day for 16 weeks

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

Contacts

Contact: Donna Davis, RN, BSN

206-764-2809

mollyr@u.washington.edu

Locations

United States, Washington
Veterans Administration Puget Sound Health Care System	Recruiting
Seattle, Washington, United States, 98108
Contact: Donna Davis, RN, BSN 206-764-2809 mollyr@u.washington.edu
Contact: Jaime Iliff 253-583-2011 Jaime.iliff@med.va.gov
Principal Investigator: Suzanne Craft, PhD
Sub-Investigator: Stennis Watson, PhD

Sponsors and Collaborators

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

This link exits the ClinicalTrials.gov site

Publications:

Reger MA, Watson GS, Frey WH 2nd, Baker LD, Cholerton B, Keeling ML, Belongia DA, Fishel MA, Plymate SR, Schellenberg GD, Cherrier MM, Craft S. Effects of intranasal insulin on cognition in memory-impaired older adults: modulation by APOE genotype. Neurobiol Aging. 2006 Mar;27(3):451-8. Epub 2005 Jun 16.

Reger MA, Craft S. Intranasal insulin administration: a method for dissociating central and peripheral effects of insulin. Drugs Today (Barc). 2006 Nov;42(11):729-39.

Fishel MA, Watson GS, Montine TJ, Wang Q, Green PS, Kulstad JJ, Cook DG, Peskind ER, Baker LD, Goldgaber D, Nie W, Asthana S, Plymate SR, Schwartz MW, Craft S. Hyperinsulinemia provokes synchronous increases in central inflammation and beta-amyloid in normal adults. Arch Neurol. 2005 Oct;62(10):1539-44.

Responsible Party:	University of Washington School of Medicine ( Suzanne Craft, PhD )
Study ID Numbers:	IA0104, 1R01AG027415-01
Study First Received:	February 21, 2007
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00438568 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

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

Additional relevant MeSH terms:

Alzheimer Disease
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Pharmacologic Actions

Cognition Disorders
Insulin
Delirium, Dementia, Amnestic, Cognitive Disorders
Hypoglycemic Agents
Mental Disorders
Dementia
Tauopathies

ClinicalTrials.gov processed this record on November 27, 2009