Abstract Details

Title Intranasal Glulisine in Down Syndrome: A Pilot Safety and Tolerability Trial

Topic Aging, Dementia, and Behavioral Neurology

Presentation(s) P4 - Poster Session 4 (5:30 PM-6:30 PM)

Poster/Presentation
Number 9-015

Objective To demonstrate the safety and tolerability of rapid acting intranasal (IN) glulisine in Down syndrome (DS)

Background DS is a genetic disorder characterized by early cerebral amyloidosis that results in young onset dementia. IN insulin has been shown to acutely improve verbal memory in mild cognitive impairment (MCI) and Alzheimer’s Disease (AD), but no trials to date have evaluated this treatment in DS. In addition, studies have shown that rapid acting insulins such as glulisine may have superior cognitive benefits compared to regular insulin.

Design/Methods We performed a double-blinded, randomized, cross-over study of IN glulisine 20 IU in 12 DS subjects using the Impel pressurized olfactory delivery (POD) device. Subjects were monitored for AEs and SAEs. Glucose finger sticks were performed pre and 30 min post-treatment. After dosing, all subjects underwent cognitive testing with the Fuld Object-Memory Evaluation and the Rivermead Behavioral Memory Test.

Results

A total of 12 DS subjects completed the trial (6 M; 6F). IN glulisine was well-tolerated in all DS subjects with no reported adverse or serious adverse events. There were no episodes of symptomatic hypoglycemia. There was no significant effects on performance with respect to the Fuld Object-Memory Evaluation and the Rivermead Behavioral Memory Test, but the study was not powered to detect this change.

Conclusions IN glulisine was well-tolerated in DS subjects. Larger phase II clinical trials of longer duration are necessary to better understand safety and efficacy of IN insulin in this patient population.

Authors/Disclosures
Michael H. Rosenbloom, MD, FAAN PRESENTER	Dr. Rosenbloom has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Esai. Dr. Rosenbloom has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Eisai.
Maria Pyle (HealthPartners Neuroscience Center)	Ms. Pyle has nothing to disclose.
	No disclosure on file
	No disclosure on file
Terry R. Barclay, PhD (HealthPartners Center for Memory and Aging)	Dr. Barclay has nothing to disclose.
Leah R. Hanson, PhD (Health Partners Neuroscience Center)	The institution of Dr. Hanson has received research support from NIA. The institution of Dr. Hanson has received research support from Merck Foundation. The institution of Dr. Hanson has received research support from Eagle Pharmaceuticals. The institution of Dr. Hanson has received research support from Research Grow Lab. The institution of Dr. Hanson has received research support from State of Minnesota. Dr. Hanson has received intellectual property interests from a discovery or technology relating to health care.

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