Parkinson DiseasePhase 2GIPDNCT03659682
GLP1R in Parkinson's Disease
A Phase 2 study testing Semaglutide in people with Parkinson Disease, run by Oslo University Hospital.
Trial summary
The purpose of the study is to test the neuroprotective and anti-inflammatory properties of semaglutide in idiopathic Parkinson's disease (PD) Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2019to 31 Dec 2024
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- We will include newly diagnosed patients with PD, age 40-75. Diagnosis of clinically established early PD will be made according to the new criteria set by the Movement Disorder Society (Berg D et al Mov Disord 2018). Enrolment must occur within a year from diagnosis. Before inclusion in the trial PD diagnosis must be supported by typical findings on dopamine transporter (DAT)scans.
Who cannot join
- Patients will be excluded if they have chronic inflammatory brain disorders, as verified or diagnosed on brain magnetic resonance imaging (MRI). Cognitive impairment in PD will be excluded by way of Mini Mental Status (MMS, score < 25 points) and Montreal Cognitive Assessment (MOCA, score <25 points). The patients will be excluded if they have diabetes type 2 and cancer, especially if they or family members have familiar medullary thyroid carcinoma, or multiple endocrine neoplastic syndrome type 2 (MEN 2), as well as those having manifest kidney failure (see side effects below). The patients cannot receive long-term treatment with anti-inflammatory drugs, or other experimental drugs. Patients who are pregnant or breastfeeding are excluded.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of GLPIR Stimulation on Neuroprotection and Inflammation in Parkinson's Disease
The purpose of the study is to test the neuroprotective and anti-inflammatory properties of semaglutide in idiopathic Parkinson's disease (PD)
Read the detailed description
The trial is a single center, double-blind, placebo-controlled study. We plan to enroll 270 newly diagnosed patents with idiopathic Parkinson's disease (PD) over 2 years. The subjects that are enrolled in the study will be randomised to receive once a week self-administered subcutaneous injections of semaglutide (1.0 mg) or placebo in a 1:1 study design.
Semaglutide has been approved by the Food and Drug Administration (FDA) and European Medicines Agency to treat adults with type 2 diabetes. The treatment has not been approved for use in patients with PD. Semaglutide is a synthetic analogue of glucagon-like peptide 1 (GLP1), which stimulates GLP1 receptors (GLP1R). Stimulation of GLP1R in B-cells in the pancreas potentiates insulin secretion and contribute to blood glucose regulation. In the brain it is known that GLP1R stimulation in the hypothalamus contribute to appetite and body weight regulation. Besides these known GLP1R effects, GLP1R can inhibit production of pro-inflammatory cytokines in microglia, which in turn will stop/slow down degeneration of neurons in the brain. Another GLP1 agonist, exenatide, has been tested in patients with PD, showing significant improvement of motor symptoms. However, it could not be concluded whether this was caused by an symptomatic or neuroprotective effect.
Eligible participants will be treated with semaglutide or placebo for 24 months in a double blind period 1 of the study. Thereafter both groups will receive semaglutide for another 2 years in an open period 2 of the study. The study will measure effects of semaglutide on motor symptoms (assessed by changes in the MDS-UPDRS part III, and in levo-dopa equivalents), on nigrostriatal degeneration (assessed by changes in DAT-scan uptake), on cognitive function (assessed by MME and MOCA, on quality of life (assessed by EQFDQ, PDQ) and on non-motor symptoms of PD (assessed by NMSS).The tests will be performed at baseline, after 12, 24, 36 and 48 months of the study. Blood and cerebrospinal samples will be taken to analyse inflammatory markers, and to confirm penetration of semaglutide across the blood brain barrier.
- Conditions
- Parkinson Disease
- Being tested
- Semaglutide
- Keywords
- GLP1R, neuroprotection, inflammation
- Medical subject headings
- Parkinson Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
subcutaneous, 1.0 mg, weekly, 48 months
| Study group | Role | What they receive |
|---|---|---|
| semaglutide | Active comparator | Ozempic- 1.0 mg administered subcutaneously once weekly Receives: Drug: Semaglutide |
| placebo | Placebo comparator | Placebo, 1.0 mg administered subcutaneously once weekly Receives: Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Function
MDS-UPDRS part 3 in OFF medication state
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start2 Jan 2019 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- delayed start design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vidar Gundersen, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659682
- Sponsor's protocol ID
- 120262PARK
- Acronym
- GIPD
- Status last verified
- Sep 2018
- First submitted
- 3 Sep 2018
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of GLPIR Stimulation on Neuroprotection and Inflammation in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03659682
- Acronym / sponsor ID
- GIPD / 120262PARK
- Conditions
- Parkinson Disease
- Keywords
- GLP1R, neuroprotection, inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 2 Jan 2019 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Sep 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 the study is to test the neuroprotective and anti-inflammatory properties of semaglutide in idiopathic Parkinson's disease (PD)
Detailed description
The trial is a single center, double-blind, placebo-controlled study. We plan to enroll 270 newly diagnosed patents with idiopathic Parkinson's disease (PD) over 2 years. The subjects that are enrolled in the study will be randomised to receive once a week self-administered subcutaneous injections of semaglutide (1.0 mg) or placebo in a 1:1 study design.
Semaglutide has been approved by the Food and Drug Administration (FDA) and European Medicines Agency to treat adults with type 2 diabetes. The treatment has not been approved for use in patients with PD. Semaglutide is a synthetic analogue of glucagon-like peptide 1 (GLP1), which stimulates GLP1 receptors (GLP1R). Stimulation of GLP1R in B-cells in the pancreas potentiates insulin secretion and contribute to blood glucose regulation. In the brain it is known that GLP1R stimulation in the hypothalamus contribute to appetite and body weight regulation. Besides these known GLP1R effects, GLP1R can inhibit production of pro-inflammatory cytokines in microglia, which in turn will stop/slow down degeneration of neurons in the brain. Another GLP1 agonist, exenatide, has been tested in patients with PD, showing significant improvement of motor symptoms. However, it could not be concluded whether this was caused by an symptomatic or neuroprotective effect.
Eligible participants will be treated with semaglutide or placebo for 24 months in a double blind period 1 of the study. Thereafter both groups will receive semaglutide for another 2 years in an open period 2 of the study. The study will measure effects of semaglutide on motor symptoms (assessed by changes in the MDS-UPDRS part III, and in levo-dopa equivalents), on nigrostriatal degeneration (assessed by changes in DAT-scan uptake), on cognitive function (assessed by MME and MOCA, on quality of life (assessed by EQFDQ, PDQ) and on non-motor symptoms of PD (assessed by NMSS).The tests will be performed at baseline, after 12, 24, 36 and 48 months of the study. Blood and cerebrospinal samples will be taken to analyse inflammatory markers, and to confirm penetration of semaglutide across the blood brain barrier.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- delayed start design
| Arm | Type | Receives |
|---|---|---|
| semaglutide | Active comparator | Drug: SemaglutideOzempic- 1.0 mg administered subcutaneously once weekly |
| placebo | Placebo comparator | Drug: SemaglutidePlacebo, 1.0 mg administered subcutaneously once weekly |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- We will include newly diagnosed patients with PD, age 40-75. Diagnosis of clinically established early PD will be made according to the new criteria set by the Movement Disorder Society (Berg D et al Mov Disord 2018). Enrolment must occur within a year from diagnosis. Before inclusion in the trial PD diagnosis must be supported by typical findings on dopamine transporter (DAT)scans.
Key exclusion criteria (1 listed)
- Patients will be excluded if they have chronic inflammatory brain disorders, as verified or diagnosed on brain magnetic resonance imaging (MRI). Cognitive impairment in PD will be excluded by way of Mini Mental Status (MMS, score < 25 points) and Montreal Cognitive Assessment (MOCA, score <25 points). The patients will be excluded if they have diabetes type 2 and cancer, especially if they or family members have familiar medullary thyroid carcinoma, or multiple endocrine neoplastic syndrome type 2 (MEN 2), as well as those having manifest kidney failure (see side effects below). The patients cannot receive long-term treatment with anti-inflammatory drugs, or other experimental drugs. Patients who are pregnant or breastfeeding are excluded.
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 |
|---|---|---|
| Semaglutidesubcutaneous, 1.0 mg, weekly, 48 months | Drug | placebo, semaglutide |
Primary outcome
Motor Function
Time frame: 48 months
MDS-UPDRS part 3 in OFF medication state
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Semaglutide in people with Parkinson Disease, run by Oslo University Hospital.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanne F Harbo, MD, PhD (+47 230 72246, h.f.harbo@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Function (time frame: 48 months). 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 6 Sep 2018.