Overview
Safety and Efficacy of Liraglutide in Parkinson's Disease
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
2022-06-30
2022-06-30
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Cedars-Sinai Medical CenterCollaborators:
Novo Nordisk A/SThe Cure Parkinson's Trust
Treatments:
LiraglutideCriteria
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