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GLP1R in Parkinson's Disease (GIPD)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03659682
Recruitment Status : Not yet recruiting
First Posted : September 6, 2018
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Vidar Gundersen, Oslo University Hospital

Study Description
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Brief Summary:
The purpose of the study is to test the neuroprotective and anti-inflammatory properties of semaglutide in idiopathic Parkinson's disease (PD)

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Semaglutide Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: delayed start design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of GLPIR Stimulation on Neuroprotection and Inflammation in Parkinson's Disease
Estimated Study Start Date : January 2, 2019
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: semaglutide
Ozempic- 1.0 mg administered subcutaneously once weekly
 Drug: Semaglutide
subcutaneous, 1.0 mg, weekly, 48 months
Placebo Comparator: placebo
Placebo, 1.0 mg administered subcutaneously once weekly
 Drug: Semaglutide
subcutaneous, 1.0 mg, weekly, 48 months


Outcome Measures
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Primary Outcome Measures :
  1. Motor Function [ Time Frame: 48 months ]
    MDS-UPDRS part 3 in OFF medication state


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

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): NCT03659682


Contacts
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Contact: Hanne F Harbo, MD, PhD +47 230 72246 h.f.harbo@medisin.uio.no

Sponsors and Collaborators
Oslo University Hospital
More Information
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Responsible Party: Vidar Gundersen, Neurologist, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03659682    
Other Study ID Numbers: 120262PARK
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Vidar Gundersen, Oslo University Hospital:
GLP1R, neuroprotection, inflammation
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