Memory Disorders Clinical Trial
Official title:
Mechanisms of Insulin Facilitation of Memory
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.
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).
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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