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Trial record 3 of 79 for:    the effect of exenatide

Effects of Exenatide on Motor Function and the Brain

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ClinicalTrials.gov Identifier: NCT03456687
Recruitment Status : Active, not recruiting
First Posted : March 7, 2018
Last Update Posted : June 8, 2021
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE March 1, 2018
First Posted Date  ICMJE March 7, 2018
Last Update Posted Date June 8, 2021
Actual Study Start Date  ICMJE June 5, 2018
Actual Primary Completion Date October 16, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2018)
  • Change in free-water accumulation in the substantia nigra [ Time Frame: Baseline and one-year ]
    12-month study in PD to watch the effect of Exenatide on the progressive increase of free-water accumulation in the substantia nigra.
  • Change in blood oxygen level-dependent(BOLD) signal in the posterior putamen. [ Time Frame: Baseline and one-year ]
    12-month study in PD to watch the effect of Exenatide on BOLD signal in the posterior putamen.
  • Change in blood oxygen level-dependent(BOLD) signal in M1. [ Time Frame: Baseline and one-year ]
    12-month study in PD to watch the effect of Exenatide on BOLD signal in M1.
  • Change in blood oxygen level-dependent(BOLD) signal in the supplementary motor area(SMA). [ Time Frame: Baseline and one-year ]
    12-month study in PD to watch the effect of Exenatide on BOLD signal in the SMA.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Exenatide on Motor Function and the Brain
Official Title  ICMJE Effects of Exenatide on Motor Function and the Brain
Brief Summary The purpose of this research study is to investigate how the brain and motor behavior changes Parkinson's Disease (PD) over time in response to Exenatide. In previous clinical trials, PD patients have experienced symptomatic improvement on Exenatide and literature suggests it may help slow the progression of Parkinson's. Both will be evaluated in this study.
Detailed Description

Participants will receive baseline testing to confirm a diagnosis of Parkinson's Disease and to determine eligibility in the research study. All of the participants in this study will receive the study drug (Exenatide). The study drug will be provided at the end of the first visit, and participants will be administered the drug once per week for the duration of the study (1 year).

During the research study the following test may occur: (1) questionnaires about quality of life and depression; (2) tests to measure strength and motor function; (3) tests to measure cognition; (4) orientation session to learn a precision gripping task; (5) functional MRI scan of the brain; (6) structural MRI scan of the brain.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE Drug: Exenatide
Exenatide will be administered through a subcutaneous injection once per week for the duration of the study (1 year).
Other Names:
  • Bydureon
  • Glucagon-like peptide-1 receptor agonist
Study Arms  ICMJE Experimental: Exenatide
This group will receive a weekly Exenatide 2mg injection for one year.
Intervention: Drug: Exenatide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 16, 2020)
5
Original Estimated Enrollment  ICMJE
 (submitted: March 1, 2018)
20
Estimated Study Completion Date  ICMJE May 2022
Actual Primary Completion Date October 16, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients clinically diagnosed with Parkinson's disease (PD) through use of the UK PD brain bank diagnostic criteria
  • early stage PD patients within 5 years of diagnosis who have never taken Exenatide for any reason
  • PD patients with a Hoehn and Yahr stage less than or equal to 2 when on medication
  • patients able and willing to sign informed consent.

Exclusion Criteria:

  • individuals who have any type of implanted electrical device (such as a cardiac pacemaker or a neurostimulator)
  • individuals with a certain type of metallic clip in the body (i.e., an aneurysm clip in the brain)
  • claustrophobia
  • women who are or might be pregnant and nursing mothers. Pregnancy tests will be carried out for each female subject prior to the MRI scan.
  • psychiatric disorders or dementia
  • other neurologic and orthopedic problems that impair hand movements and walking
  • individuals actively participating in another trial of a device, drug or surgical treatment for Parkinson's disease
  • individuals who have a history metalworking involving cutting processes such as grinding, filing, shaving, and threading, will need radiological clearance to participate in this study. Specifically, individuals who report a history of metalworking will be referred to Radiology at Shands University of Florida(UF) for an orbitofrontal x-ray.
  • individuals who have sustained an eye injury involving metal will also be referred to Radiology at Shands UF for an orbitofrontal x-ray.
  • prior stroke or brain tumor
  • cognitive impairment as assessed by a Montreal Cognitive Assessment score < 23
  • individuals unwilling to comply with the study procedures
  • history of gallstones, digestion problems (such as gastroparesis), severe gastrointestinal disease, history of pancreatitis, a thyroid tumor or cancer, pancreas tumor, or kidney problems
  • severely impaired renal function with creatinine clearance less than 30 ml/min
  • hyperlipidemia defined as more than two times the upper limit of normal
  • body mass index less than 18.5
  • previous exposure to Exenatide
  • diabetes
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 77 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03456687
Other Study ID Numbers  ICMJE IRB201703187 - N
R01NS052318-13 ( U.S. NIH Grant/Contract )
OCR17539 ( Other Identifier: Universiy of Florida )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE National Institute of Neurological Disorders and Stroke (NINDS)
Investigators  ICMJE
Principal Investigator: David Vaillancourt, PhD University of Florida
PRS Account University of Florida
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP