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Effects of Exenatide on Motor Function and the Brain

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: 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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Exenatide Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Exenatide on Motor Function and the Brain
Actual Study Start Date : June 5, 2018
Actual Primary Completion Date : October 16, 2020
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Exenatide
This group will receive a weekly Exenatide 2mg injection for one year.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 77 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT03456687


Locations
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United States, Florida
Laboratory for Rehabilitation Neuroscience
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: David Vaillancourt, PhD University of Florida
More Information
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03456687    
Other Study ID Numbers: IRB201703187 - N
R01NS052318-13 ( U.S. NIH Grant/Contract )
OCR17539 ( Other Identifier: Universiy of Florida )
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: June 8, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University of Florida:
Exenatide
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Exenatide
 Glucagon
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents