Investigation of the Safety of Intranasal Glulisine in Down Syndrome
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Intervention: Insulin glulisine; Saline
Intervention description: Insulin (glulisine) Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril), once per study; Placebo Comparator: Placebo Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril), once per study
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin glulisine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 35 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study is a single center, randomized, double-blind, placebo-controlled, cross-over pilot
      study designed to assess the safety of intranasally (IN) delivered glulisine versus placebo
      in patients with DS. Subjects will be randomized into this cross-over study and within
      subject comparisons conducted between single treatment of intranasal insulin glulisine and
      single treatment of intranasal placebo. All subjects will also receive a single treatment of
      placebo prior to randomization to ensure adherence to study procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged 35-80 years with a Down syndrome diagnosis that is confirmed by
             karyotype.

          -  Vital signs must be within normal limits for their age. (Medically treated
             hypertension will be allowed).

          -  Must have an electrocardiogram free of clinically significant findings.

          -  Must have an authorized representative to provide written informed consent.

          -  Level of speech and comprehension of verbal commands are sufficient to understand and
             to answer simple requests.

          -  Must have a reliable caregiver or family member who agrees to accompany the subject to
             all visits, provide information about the subject as required by this protocol.

          -  Must be independent for activities of daily living.

          -  Must tolerate the initial IN treatment of placebo and adhere to study procedures.

        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.