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| 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 |
| 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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Donna Davis, RN, BSN | 206-764-2809 | mollyr@u.washington.edu |
| 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 | |
| Principal Investigator: | Suzanne Craft, PhD | University of Washington |
More Information
| 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 |
|
amyloid protein brain metabolism glucose metabolism insulin sensitivity /resistance cognition disorders |
|
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 |