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Intranasal Insulin Therapy for HIV-associated Neurocognitive Disorders
Purpose: The future treatment for HAND will likely need to include both antiretroviral therapy and adjunctive therapy to treat central nervous system (CNS) specific pathogenetic mechanisms. Insulin is involved in multiple CNS functions including food intake, metabolism, learning, and memory. Insulin has neuroprotective properties demonstrated in cell culture experiments and in vivo models, which provide strong evidence for its use as a therapeutic agent to treat HAND. The brain delivery of insulin administered via a novel nasal drug delivery device has been shown to have CNS protective, restorative, and cognitive enhancing effects in over 15 independent clinical studies. In addition to standard neuropsychological testing, the proposed clinical trial will use several novel brain imaging and CSF surrogate markers to monitor the effects of intranasal insulin therapy in HAND patients. We will conduct a 24 week double-blinded, placebo-controlled Phase I/II trial of intranasal insulin for the treatment of HAND. Participants will be randomly assigned to one of two groups: 1) Intranasal insulin, or 2) placebo administered with a nasal drug delivery device. Outcomes from these studies could have important implications for the design and implementation of future insulin modifying therapies and other neuroprotective compounds for HAND.
Not currently enrolling; future enrollment planned for 2017
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