Parkinson's DiseasePhase 1NCT03456687
Effects of Exenatide on Motor Function and the Brain
A Phase 1 study testing Exenatide in people with Parkinson's Disease, run by University of Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 77 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Exenatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2018to 25 Aug 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 77 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Laboratory for Rehabilitation Neuroscience
Gainesville, Florida, 32611
About this study
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.
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- Exenatide
- Keywords
- Exenatide
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExenatideDrug
Also called Bydureon, Glucagon-like peptide-1 receptor agonist
Exenatide will be administered through a subcutaneous injection once per week for the duration of the study (1 year).
| Study group | Role | What they receive |
|---|---|---|
| Exenatide | Experimental | This group will receive a weekly Exenatide 2mg injection for one year. Receives: Drug: Exenatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and one-year
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.
Measured: Baseline and one-year
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.
Measured: Baseline and one-year
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.
Measured: Baseline and one-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start5 Jun 2018
- Primary completion16 Oct 2020
- Study completion25 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Vaillancourt, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03456687
- Sponsor's protocol ID
- IRB201703187 - N
- Other IDs
- R01NS052318, OCR17539
- Status last verified
- Sep 2022
- First submitted
- 1 Mar 2018
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exenatide on Motor Function and the Brain
- ClinicalTrials.gov ID
- NCT03456687
- Acronym / sponsor ID
- IRB201703187 - N
- Conditions
- Parkinson's Disease
- Keywords
- Exenatide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 16 Oct 2020 (actual)
- Study completion
- 25 Aug 2021 (actual)
- First posted
- 7 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exenatide | Experimental | Drug: ExenatideThis group will receive a weekly Exenatide 2mg injection for one year. |
Who may qualify
- Ages
- 40 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExenatideAlso: Bydureon, Glucagon-like peptide-1 receptor agonistExenatide will be administered through a subcutaneous injection once per week for the duration of the study (1 year). | Drug | Exenatide |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Vaillancourt, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Exenatide in people with Parkinson's Disease, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in free-water accumulation in the substantia nigra (time frame: Baseline and one-year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022.