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

NCT00438568 | Completed Phase 2 DMC

• 3 other identifiers: 30579-B5R01AG0274151R01AG027415-01
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Alzheimer's Disease

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Changes in cognition

  every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks)

• glucose metabolism

  every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks)

• plasma biological markers

  every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks)

Secondary Outcomes (2)

• CSF biological markers

  every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks)

• cerebral glucose metabolism

  every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks)

Study Arms (3)

1

PLACEBO COMPARATOR

saline

Drug: Placebo

2

EXPERIMENTAL

10 Units

Drug: Regular Insulin

3

EXPERIMENTAL

20 Units

Drug: Regular Insulin

Interventions

Regular Insulin DRUG

administered intra-nasally twice a day for 16 weeks

Also known as: Novolin U-100

2; 3

Placebo DRUG

administered intra-nasally twice a day for 16 weeks

Also known as: saline

1

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Veterans Administration Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

Related Publications (4)

• 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. doi: 10.1016/j.neurobiolaging.2005.03.016. Epub 2005 Jun 16.

  PMID: 15964100 BACKGROUND

• 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. doi: 10.1358/dot.2006.42.11.1007675.

  PMID: 17171192 BACKGROUND

• 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. doi: 10.1001/archneur.62.10.noc50112.

  PMID: 16216936 BACKGROUND

• Craft S, Baker LD, Montine TJ, Minoshima S, Watson GS, Claxton A, Arbuckle M, Callaghan M, Tsai E, Plymate SR, Green PS, Leverenz J, Cross D, Gerton B. Intranasal insulin therapy for Alzheimer disease and amnestic mild cognitive impairment: a pilot clinical trial. Arch Neurol. 2012 Jan;69(1):29-38. doi: 10.1001/archneurol.2011.233. Epub 2011 Sep 12.

  PMID: 21911655 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Amyloidosis; Cognition Disorders

Interventions

Insulin; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Suzanne Craft, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2007
• First Posted: February 22, 2007
• Study Start: June 1, 2006
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: September 14, 2012

Record last verified: 2012-09

Locations

US (1)