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Investigation of the Safety of Intranasal Glulisine in Down Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02432716
Recruitment Status : Completed
First Posted : May 4, 2015
Results First Posted : December 6, 2019
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
HealthPartners Institute

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 : October 18, 2018
Actual Study Completion Date : October 18, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Insulin (glulisine), then Placebo
Participants first receive one dose of Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril). After a washout period of 2 weeks, they then received one dose of placebo, Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril).
Drug: Insulin glulisine
Insulin (glulisine) Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril), once per study
Other Name: insulin, glulisine, Apidra

Drug: Saline
Placebo Comparator: Placebo Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril), once per study
Other Name: Placebo

Experimental: Placebo, then Insulin (glulisine)
Participants first receive one dose of placebo, Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril). After a washout period of 2 weeks, they then received one dose of Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril).
Drug: Insulin glulisine
Insulin (glulisine) Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril), once per study
Other Name: insulin, glulisine, Apidra

Drug: Saline
Placebo Comparator: Placebo Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril), once per study
Other Name: Placebo




Primary Outcome Measures :
  1. Safety Measured by Adverse Events [ Time Frame: 1 year ]
    Number of adverse and/or serious events


Secondary Outcome Measures :
  1. Cognitive Change Measured by Fuld Object-Memory Evaluation (FOME) [ Time Frame: 20 minutes ]

    During the examination, a patient is presented with ten common objects they are asked to identify by touch. The test uses distraction to test recall. For all, a higher score indicates a better outcome.

    • Learning curve is the number of objects the difference in the number of items they are able to correctly identify from the greater of trials 4 or 5 compared to trial 1. Range: 0-10
    • Total immediate recall is the number of objects recalled over all of the trials. Range: 0-50
    • Total delayed recall is the number of objects recalled after 5 minutes. Range: 0-10
    • Recognition memory is the number of items correct from a multiple choice list of three when unable to correctly identify items from delayed recall. Range: 0-10
    • Retention estimate is the number of items recalled after 5 minutes or being reminded with multiple choice. Range: 0-10

  2. Memory Retention Measured by Fuld Object-Memory Evaluation (FOME) [ Time Frame: 20 minutes ]
    Memory retention is the percentage of items correctly identify during the delayed recall trial compared storage trial 5. Range: 0-100 percent. A higher percentage indicates a better outcome.

  3. Cognitive Change Measured by Rivermead Behavioral Memory Test (RBMT-C) [ Time Frame: 20 minutes ]

    The RBMT-C provides an objective measure of everyday memory problems reported and observed in subjects with memory difficulties. The test is standardized for use with children ranging in age from 5 to 10 years. Here, we used it for evaluation of Down Syndrome subjects. The story recall subtests involves immediate free recall, cued recall, and delayed recall of short story material which is presented orally to subjects by the examiner. The RBMT-C is appealing for use in this population because the task is engaging, simple, and has been shown in other studies to be an effective measure of memory functions. For all, a higher score means a better outcome.

    • Immediate Recall is the number of story elements recalled right after the story is complete. Range: 0-31
    • Delayed Recall is the number of story elements recalled after a delay. Range: 0-31

  4. Memory Retention Measured by Rivermead Behavioral Memory Test (RBMT-C). [ Time Frame: 20 minutes ]
    The RBMT-C provides an objective measure of everyday memory problems reported and observed in subjects with memory difficulties. The test is standardized for use with children ranging in age from 5 to 10 years. Here, we used it for evaluation of Down Syndrome subjects. The story recall subtests involves immediate free recall, cued recall, and delayed recall of short story material which is presented orally to subjects by the examiner. The RBMT-C is appealing for use in this population because the task is engaging, simple, and has been shown in other studies to be an effective measure of memory functions. Memory retention is the percentage of story elements recalled after a delay compared to right after the story is complete. Range: 0-100. A higher score means a better outcome.



Information from the National Library of Medicine

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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.

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


Locations
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United States, Minnesota
HealthPartners Neuroscience Center
Saint Paul, Minnesota, United States, 55130
Sponsors and Collaborators
HealthPartners Institute
Investigators
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Principal Investigator: Michael H Rosenbloom, MD HealthPartners Institute
  Study Documents (Full-Text)

Documents provided by HealthPartners Institute:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT02432716    
Other Study ID Numbers: HealthPartnersRF
First Posted: May 4, 2015    Key Record Dates
Results First Posted: December 6, 2019
Last Update Posted: December 6, 2019
Last Verified: June 2018
Additional relevant MeSH terms:
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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