Safety and Efficacy of Liraglutide in Parkinson's Disease

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's Disease, Liraglutide, Antidiabetic agents, GLP-1 agonists, Insulin resistance Read More

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