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
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Drug: Semaglutide||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||delayed start design|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Active Comparator: semaglutide
Ozempic- 1.0 mg administered subcutaneously once weekly
subcutaneous, 1.0 mg, weekly, 48 months
Placebo Comparator: placebo
Placebo, 1.0 mg administered subcutaneously once weekly
subcutaneous, 1.0 mg, weekly, 48 months
- Motor Function [ Time Frame: 48 months ]MDS-UPDRS part 3 in OFF medication state
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
|Contact: Hanne F Harbo, MD, PhD||+47 230 firstname.lastname@example.org|