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Trial record 6 of 42 for:    Recruiting, Not yet recruiting, Available Studies | "Down Syndrome"

Investigation of the Safety of Intranasal Glulisine in Down Syndrome

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ClinicalTrials.gov Identifier: NCT02432716
Recruitment Status : Recruiting
First Posted : May 4, 2015
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):

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)
Estimated 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
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome
U.S. FDA Resources

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

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02432716


Contacts
Contact: Maria Pyle, RN 651-254-0769 maria.x.pyle@healthpartners.com

Locations
United States, Minnesota
HealthPartners Neuroscience Center Recruiting
Saint Paul, Minnesota, United States, 55130
Contact: Maria Pyle, RN    651-495-6370    maria.x.pyle@healthpartners.com   
Principal Investigator: Michael H Rosenbloom, MD         
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    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017

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, Globin Zinc
Insulin glulisine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs