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Trials / Completed

CompletedNCT01145482

Mechanisms of Insulin Facilitation of Memory

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
12 (actual)
Sponsor
University of Texas at Austin · Academic / Other
Sex
All
Age
21 Years
Healthy volunteers
Not accepted

Summary

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.

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).

Conditions

Interventions

TypeNameDescription
DRUGInsulin20 IU of insulin was administered once daily on two occasions in either the first intervention period or second intervention period using a nasal spray bottle
OTHERSaline200 micro liters of saline was administered once daily on two separate occasions in either the first intervention period or second intervention period using a nasal spray bottle

Timeline

Start date
2010-07-01
Primary completion
2014-04-01
Completion
2014-04-01
First posted
2010-06-16
Last updated
2014-11-03
Results posted
2014-11-03

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01145482. Inclusion in this directory is not an endorsement.

Mechanisms of Insulin Facilitation of Memory (NCT01145482) · Clinical Trials Directory