Investigation of the Safety of Intranasal Glulisine in Down Syndrome

Exclusion Criteria

• •Any current psychiatric or neurologic diagnosis other than Down syndrome or Down syndrome with dementia that is judged to impact cognition.
• •Subjects who currently meet or have within the past five years met DSM-IV (Diagnostic and Statistical Manual) criteria for drug or alcohol abuse or dependence.
• •Subjects residing in a skilled nursing facility or subjects who are anticipated to enter a nursing home within the next 6 months. (Subjects may reside in group homes, assisted living, or other residential settings where they do not require 24 hour skilled nursing.)
• •Subjects receiving any experimental drug for Down syndrome within the past 30 days of screening visit.
• •Subjects with significant allergies to or other significant intolerance insulin.
• •Presence of active seizure disorder.
• •Presence of significant aggression or agitation that may impact participation with testing and IN administration. All subjects must have NPI-C aggression and agitation subscore ≤ 4 (severity ≤ 2; frequency ≤ 2).
• •Significant cerebrovascular disease with Modified Hachinski Score\>4.
• •Subjects who may not be able to comply with the protocol or perform the outcomes measures due to significant hearing or visual impairment or other issues judged relevant by the investigators.
• •Subject has been diagnosed with any form of diabetes mellitus, actively takes insulin, or has HbA1c \> 6.1% at screening.