Investigation of the Safety of Intranasal Glulisine in Down Syndrome
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 35 - 80 |
| Updated: | 12/15/2018 |
| Start Date: | April 2015 |
| End Date: | April 2019 |
A Double-Blind, Placebo-Controlled Pilot Investigation of the Safety of Intranasal Glulisine in Down Syndrome
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.
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.
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.
We found this trial at
1
site
295 Phalen Boulevard
Saint Paul, Minnesota 55130
Saint Paul, Minnesota 55130
Principal Investigator: Michael H Rosenbloom, MD
Phone: 651-495-6370
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