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SNIFF 120

CompletedPhase 2

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

Therapeutic Effects of Intranasal Insulin Administration in AD

Lead sponsor

University of Washington

Asset

Insulin

Listed sites

Recruiting sites

Enrollment

173

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criterion

•Alzheimer's disease

Primary endpoints

•Changes in cognition•Glucose metabolism•Plasma biological markers

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Nih1R01AG027415-01

Org study ID30579-B

Nih5R01AG027415

NCT IDNCT00438568

Timeline

Milestones

Study start2006-06 (month precision)

Study first posted2007-02-22estimated

Primary completion2011-12actual (month precision)

Study completion2011-12actual (month precision)

Last update posted2012-09-14estimated

Assets

Drug assets

Insulin

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age55 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Fluid / digital biomarkers

1 endpoint

Secondary/protocol endpoint

CSF biological markers