Investigation of the Safety of Intranasal Glulisine in Down Syndrome

• ClinicalTrials.gov Identifier: NCT02432716
• Recruitment Status: Completed
• First Posted: May 4, 2015
• Last Update Posted: August 7, 2019
• Sponsor: HealthPartners Institute
• Information provided by (Responsible Party): HealthPartners Institute

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Down Syndrome	Drug: Insulin glulisine; Drug: Saline	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Double-Blind, Placebo-Controlled Pilot Investigation of the Safety of Intranasal Glulisine in Down Syndrome
• Study Start Date: April 2015
• Actual Primary Completion Date: January 2019
• Actual Study Completion Date: January 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Insulin (glulisine); Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril), once per study	Drug: Insulin glulisine; Insulin (glulisine) Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril), once per study; Other Name: insulin, glulisine, Apidra
Placebo Comparator: Placebo; Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril), once per study	Drug: Saline; Placebo Comparator: Placebo Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril), once per study; Other Name: Placebo

Outcome Measures

Primary Outcome Measures :

1. Safety measured by adverse events [ Time Frame: 1 year ]
   Number of adverse and/or serious events
2. Feasibility measured by CAMDEX-DS [ Time Frame: 1 year ]
   Feasibility of performing a cognitive assessment on a patient with Down syndrome.

Secondary Outcome Measures :

1. Cognitive change measured by Fuld Object-Memory Evaluation [ Time Frame: 1 year ]
   Cognitive change measured by Fuld Object-Memory Evaluation
2. Cognitive change measured by Reivermead Behavioral Memory Test [ Time Frame: 1 year ]
   Cognitive change measured by Reivermead Behavioral Memory Test

Eligibility Criteria

• Ages Eligible for Study: 35 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Minnesota

HealthPartners Neuroscience Center

Saint Paul, Minnesota, United States, 55130

Sponsors and Collaborators

HealthPartners Institute

Investigators

• Principal Investigator: Michael H Rosenbloom, MD; HealthPartners Institute

More Information

• Responsible Party: HealthPartners Institute
• ClinicalTrials.gov Identifier: NCT02432716 History of Changes
• Other Study ID Numbers: HealthPartnersRF
• First Posted: May 4, 2015
• Last Update Posted: August 7, 2019
• Last Verified: June 2018

Additional relevant MeSH terms:

Down Syndrome; Syndrome; Disease; Pathologic Processes; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Insulin; Insulin, Globin Zinc; Insulin glulisine; Hypoglycemic Agents; Physiological Effects of Drugs