Investigation of the Safety of Intranasal Glulisine in Down Syndrome

NCT02432716 | Completed Phase 1 Results DMC

• 1 other identifier: HealthPartnersRF
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome

Outcome Measures

Primary Outcomes (1)

• Safety Measured by Adverse Events

  Number of adverse and/or serious events

  1 year

Secondary Outcomes (4)

• Cognitive Change Measured by Fuld Object-Memory Evaluation (FOME)

  20 minutes

• Memory Retention Measured by Fuld Object-Memory Evaluation (FOME)

  20 minutes

• Cognitive Change Measured by Rivermead Behavioral Memory Test (RBMT-C)

  20 minutes

• Memory Retention Measured by Rivermead Behavioral Memory Test (RBMT-C).

  20 minutes

Study Arms (2)

Insulin (glulisine), then Placebo

EXPERIMENTAL

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; Drug: Saline

Placebo, then Insulin (glulisine)

EXPERIMENTAL

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; Drug: Saline

Interventions

Insulin glulisine DRUG

Insulin (glulisine) Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril), once per study

Also known as: insulin, glulisine, Apidra

Insulin (glulisine), then Placebo; Placebo, then Insulin (glulisine)

Saline DRUG

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

Also known as: Placebo

Insulin (glulisine), then Placebo; Placebo, then Insulin (glulisine)

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (1)

HealthPartners Neuroscience Center

Saint Paul, Minnesota, 55130, United States

Location

Related Publications (1)

• Rosenbloom M, Barclay T, Johnsen J, Erickson L, Svitak A, Pyle M, Frey W, Hanson LR. Double-Blind Placebo-Controlled Pilot Investigation of the Safety of a Single Dose of Rapid-Acting Intranasal Insulin in Down Syndrome. Drugs R D. 2020 Mar;20(1):11-15. doi: 10.1007/s40268-020-00296-2.

  PMID: 32077057 DERIVED

MeSH Terms

Conditions

Down Syndrome

Interventions

insulin glulisine; Insulin; Sodium Chloride

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Clinical Trial Manager
• Organization: HealthPartners Neuroscience Research

maria.x.pyle@healthpartners.com

651-495-6363

Study Officials

• Michael H Rosenbloom, MD

  HealthPartners Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: May 4, 2015
• Study Start: April 1, 2015
• Primary Completion: October 18, 2018
• Study Completion: October 18, 2018
• Last Updated: December 6, 2019
• Results First Posted: December 6, 2019

Record last verified: 2018-06

Locations

US (1)