Mild Cognitive Impairment Clinical Trial
— SNIFF 120Official title:
Therapeutic Effects of Intranasal Insulin Administration in AD
Verified date | September 2012 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 173 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 55 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Veterans Administration Puget Sound Health Care System | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | National Institute on Aging (NIA) |
United States,
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. — View Citation
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. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in cognition | every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks) | No | |
Primary | glucose metabolism | every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks) | No | |
Primary | plasma biological markers | every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks) | No | |
Secondary | CSF biological markers | every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks) | No | |
Secondary | cerebral glucose metabolism | every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks) | No |
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