Mechanisms of Insulin Facilitation of Memory
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Purpose
The study described in the present application will test the hypothesis that insulin mediated facilitation of memory in Alzheimer's disease (AD) is achieved through enhanced glutamatergic neurotransmission due to improvements in cerebral glucose metabolism. The effect of a single dose of intranasal insulin on memory and cerebral glutamate concentrations in adults with mild AD or amnestic mild cognitive impairment (aMCI), the presumed prodromal phase of AD will be studied. Successful completion of this study may set the stage for a larger-scale treatment trial of intranasal insulin for adults with memory disorders. However, the use of insulin in this manner at this point in time is purely experimental.
| Condition | Intervention |
|---|---|
|
Memory Insulin |
Drug: NovoLog Insulin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Mechanisms of Insulin Facilitation of Memory |
- cerebral glutamate concentration [ Time Frame: 15 minutes post insulin or placebo administration ] [ Designated as safety issue: No ]glutamate concentration will be measured non-invasively using 1H MRS
- cognitive performance [ Time Frame: 15 minutes post insulin or placebo administration ] [ Designated as safety issue: No ]memory, executive function, mental status
| Estimated Enrollment: | 25 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: insulin
within subjects placebo controlled design - everyone will receive intervention (insulin) and placebo (saline) during separate visits
|
Drug: NovoLog Insulin
Saline and insulin (NovoLog) will be ordered though the UT Student Health Services Pharmacy (Sharon Roberson, Chief Pharmacist) and stored at 4°C, according to standard pharmacy protocols. Three ml doses of saline or insulin will be packaged in nasal spray bottles (e.g., Spectrum Pharmacy Products bottles 969-17404P and actuators 551-24362P) designed to deliver 100μL dose with each spray. A total volume of 200μL will be delivered during each administration (one 100μL dose in each nostril).
Other Name: NovoLog
|
Detailed Description:
The specific aims of this project will be accomplished through a cross sectional repeated measures design in which 15 participants with mild AD or amnestic MCI will undergo assessments of brain structure and function 15 minutes after a single dose of insulin (20 IU) or placebo. Insulin and placebo conditions will be counterbalanced across participants.
Intranasal insulin or placebo administration: Saline and insulin (NovoLog) will be ordered though the UT Student Health Services Pharmacy (Sharon Roberson, Chief Pharmacist) and stored at 4°C, according to standard pharmacy protocols. Three ml doses of saline or insulin will be packaged in nasal spray bottles (e.g., Spectrum Pharmacy Products bottles 969-17404P and actuators 551-24362P) designed to deliver 100μL dose with each spray. A total volume of 200μL will be delivered during each administration (one 100μL dose in each nostril).
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinical diagnosis of probable AD
- Age over 21
- Clinical Dementia Rating of 0.5 or 1.0
- Mini Mental State Exam Score>15
Exclusion Criteria:
- preexisting diabetes
- significant neurological disease that might affect cognition, other than AD, including stroke, Parkinson's disease, multiple sclerosis
- severe head injury with loss of consciousness > 30 minutes or with permanent neurological sequelae
- significant medical illness or organ failure, such as uncontrolled hypertension or cardiovascular disease, chronic obstructive pulmonary disease, liver disease, or kidney disease
- current use of anti-psychotic or anti-convulsant medications
- current or previous use of hypoglycemic agents or insulin
- MRI contraindications
- claustrophobia
- pregnancy
Contacts and Locations| Contact: Katayoon Karimi Goudarzi, MD, MA | +1 (512) 471-7926 | neurolab.ut@gmail.com |
| Contact: Andreana P Haley, PhD | +1 (512) 232-0863 | haley@mail.psy.utexas.edu |
| United States, Texas | |
| University of texas at Austin | Recruiting |
| Austin, Texas, United States, 78712 | |
| Contact: Katayoon K Goudarzi, MD,MA 512-471-7926 neurolab.ut@gmail.com | |
| Principal Investigator: Andreana P Haley, PhD | |
| Principal Investigator: | Andreana P Haley, PhD | University of Texas at Austin |
More Information
No publications provided
| Responsible Party: | Andreana P. Haley, Assistant Professor, University of Texas at Austin |
| ClinicalTrials.gov Identifier: | NCT01145482 History of Changes |
| Other Study ID Numbers: | 2010-05-0007 |
| Study First Received: | June 15, 2010 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by University of Texas at Austin:
|
Memory Insulin Alzheimer disease |
Additional relevant MeSH terms:
|
Insulin aspart Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013