Exenatide Treatment in Parkinson's Disease

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 60

Inclusion Criteria

•Diagnosis of clinically probable Parkinson’s disease.
•Males or Females.
•Hoehn and Yahr stage = 2 in the ON medication state.
•Patients are on levodopa treatment.
•No need for extended treatment adjustment, no significant motor fluctuations during the last year.
•All patients will be =25 and =80 years of age.
•Ability to self-administer, or to arrange carer administration of the trial drug.
•Signed informed consent to participate in the trial.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

•Atypical or other causes of parkinsonism.
•Prior intra-cerebral surgical intervention for Parkinson’s disease. Patients who have previously undergone Deep Brain Stimulation, intra-cerebral administration of growth factors, gene therapy or cell therapies will not be eligible.
•Already actively participating in a trial of a device, drug or surgical treatment for Parkinson’s disease.
•Previous exposure to Exenatide.
•Known abnormality on CT or MRI brain imaging considered likely to compromise compliance with trial protocol/FDG-PET acquisition.
•Patients with body mass index less than 18.5.
•Patients with diabetes mellitus type 1.
•Patients with prediabetes, or T2DM.
•History of pancreatitis.
•Severe gastrointestinal disease including gastroparesis.
•History of alcoholism.
•History of severe cardiac disease.
•History of pancreas cancer.
•History or suspicion of thyroid cancer.
•Personal or family history of medullary thyroid cancer.
•Patients with Multiple Endocrine Neoplasia 2 (MEN2) syndrome.
•End-stage renal disease or creatinine clearance < 50 ml/min.
•Hyperlipidaemia.
•Concurrent treatment with warfarin.
•Concurrent severe depression, defined as MADRS score more than 16.
•Concurrent dementia, defined as MMSE < 22.
•Pregnancy and Breastfeeding.
•Known hypersensitivity or allergy or intolerance to GLP-1.
•Known hypersensitivity to Exenatide or any of its excipients.
•Potential participants who lack the capacity to give informed consent
•Any medical, psychiatric or other condition which in the investigator’s opinion compromises the potential participant's ability to participate in the trial.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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