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Effects of Exenatide on Motor Function and the Brain

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Exenatide
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Exenatide

Eligibility Criteria

40 Years - 77 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Laboratory for Rehabilitation Neuroscience

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exenatide

Arm Description

This group will receive a weekly Exenatide 2mg injection for one year.

Outcomes

Primary Outcome Measures

Change in free-water accumulation in the substantia nigra
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.
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.
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).
12-month study in PD to watch the effect of Exenatide on BOLD signal in the SMA.

Secondary Outcome Measures

Full Information

First Posted
March 1, 2018
Last Updated
September 14, 2022
Sponsor
University of Florida
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT03456687
Brief Title
Effects of Exenatide on Motor Function and the Brain
Official Title
Effects of Exenatide on Motor Function and the Brain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
June 5, 2018 (Actual)
Primary Completion Date
October 16, 2020 (Actual)
Study Completion Date
August 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Exenatide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exenatide
Arm Type
Experimental
Arm Description
This group will receive a weekly Exenatide 2mg injection for one year.
Intervention Type
Drug
Intervention Name(s)
Exenatide
Other Intervention Name(s)
Bydureon, Glucagon-like peptide-1 receptor agonist
Intervention Description
Exenatide will be administered through a subcutaneous injection once per week for the duration of the study (1 year).
Primary Outcome Measure Information:
Title
Change in free-water accumulation in the substantia nigra
Description
12-month study in PD to watch the effect of Exenatide on the progressive increase of free-water accumulation in the substantia nigra.
Time Frame
Baseline and one-year
Title
Change in blood oxygen level-dependent(BOLD) signal in the posterior putamen.
Description
12-month study in PD to watch the effect of Exenatide on BOLD signal in the posterior putamen.
Time Frame
Baseline and one-year
Title
Change in blood oxygen level-dependent(BOLD) signal in M1.
Description
12-month study in PD to watch the effect of Exenatide on BOLD signal in M1.
Time Frame
Baseline and one-year
Title
Change in blood oxygen level-dependent(BOLD) signal in the supplementary motor area(SMA).
Description
12-month study in PD to watch the effect of Exenatide on BOLD signal in the SMA.
Time Frame
Baseline and one-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
77 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Vaillancourt, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory for Rehabilitation Neuroscience
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Exenatide on Motor Function and the Brain

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