Safety and Efficacy of Liraglutide in Parkinson's Disease

• Status: Active, not recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to test the efficacy and safety of liraglutide in the treatment of patients with idiopathic Parkinson's disease (PD).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cedars-Sinai Medical Center
• Collaborators: Novo Nordisk A/S; The Cure Parkinson's Trust
• Treatments: Liraglutide

Criteria

Inclusion Criteria:

• Diagnosis of idiopathic PD according to the United Kingdom Parkinson's Disease Society Brain Bank (UKPDSBB) criteria for at least 2 years

• Responsive to levodopa or dopaminergic treatment

• Male or female between 25 and 85 years of age at time of enrollment

• Women of child-bearing potential (WOCBP) must agree to use a reliable method of contraception (e.g., oral contraceptive or long-term injectable or implantable hormonal contraceptive, double barrier methods (such as condom plus diaphragm, condom plus spermicide foam, condom plus sponge), or intra-uterine devices) throughout the duration of the trial period and must have a negative serum pregnancy test at screening

• Male patients with female partners who have child bearing potential must agree to use adequate contraception throughout the duration of the trial period

• Capacity to give informed consent

• Ability to self-administer, or to arrange a care partner to administer trial drug, to comply with trial protocol, and to attend necessary clinic visits off medication

Exclusion Criteria:

• Diagnosis or suspicion of other causes for Parkinsonism, including drug- or toxin-induced parkinsonism and other neurodegenerative conditions, including multiple system atrophy, progressive supranuclear palsy, Huntington's disease, Wilson's disease, or Alzheimer's disease

• Active treatment with anticholinergic medications (e.g., trihexyphenidyl, tricyclic antidepressants)

• Known abnormality on CT or MRI brain imaging considered to cause symptoms or signs of neurological dysfunction, or considered likely to compromise compliance with trial protocol

• Concurrent dementia defined by a score lower than 120 on the MADRS-2 and/or inability to complete scale per neuropsychologist discretion

• Concurrent severe depression defined by a score greater than 29 on the Beck Depression Inventory

• Prior intracerebral surgical intervention for PD, including deep brain stimulation, lesional surgery, growth factor administration, gene therapy, or cell transplant

• Already actively participating in a trial of a device, drug, or surgical treatment for PD, or trial participation within 30 days prior to the baseline visit

• Diagnosis of diabetes mellitus of any type, established historically or by:

• Fasting plasma glucose levels equal or above 126 mg/dl

• Hemoglobin A1c equal or above 6.5%

• Active treatment with oral antidiabetic medications

• History of severe cardiac disease (e.g., angina, myocardial infarction, or cardiac surgery) in the preceding year

• Significant systemic illness likely to result in deterioration of the patient's condition or, in the Investigator's opinion, affect the patient's safety during the study, including in particular:

1. History of pancreatitis

2. Personal or family history of medullary thyroid carcinoma

3. History of multiple endocrine neoplasia syndrome type 2

4. History of alcoholism

5. Severe gastrointestinal disease, including gastroparesis

6. Treatment with immunosuppressive medications (e.g., systemic corticosteroids) within the last 90 days or chemotherapeutic agents for malignancy within the last 2 years

7. Severe renal insufficiency (CrCl <30)

8. Moderate or severe hepatic impairment

9. Severe hypertriglyceridemia (triglycerides >500 mg/dl)

• Females who are pregnant or breast feeding

• Prior serious hypersensitivity reaction to Victoza or any of the product components 10) Body Mass Index <18.5