Trial of Exenatide for Parkinson's Disease (EXENATIDE-PD)

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This study is a clinical trial in patients with Parkinson's disease, of a drug called Exenatide which is already licensed for the treatment of patients with Type 2 Diabetes. There have been several groups that have confirmed that Exenatide has beneficial effects on nerve cells when tested in the laboratory, that raises the possibility that Exenatide may slow down or stop the degenerative process of Parkinson's disease. In an open label trial in patients with Parkinson's disease who self administered the drug for 1 year, we have previously shown that the drug is well tolerated and shows encouraging effects on the movement and non-movement aspects of the disease, even 2 months after patients stopped administering the drug. The next step is therefore to formally evaluate whether Exenatide really is a potential "neuroprotective" drug, i.e. stops the nerve cells dying in Parkinson's disease, by conducting a double blind, placebo controlled trial.

The primary objective is to compare the effectiveness of Exenatide versus placebo on the MDS UPDRS part 3 motor subscale in the "practically defined OFF medication state" in patients with moderate severity PD.

Secondary Outcome Measures :

Safety and tolerability [ Time Frame: 60 weeks ]

• Compare differences at 48 and 60 weeks between the Exenatide and placebo trial arms in:

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Ages Eligible for Study:

25 Years to 75 Years (Adult, Older Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Diagnosis of Parkinson's disease.

Males or Females.

Hoehn and Yahr stage ≤ 2.5 in the On medication state.

Between 25 and 75 years of age.

On dopaminergic treatment with wearing off phenomena.

Ability to self-administer, or to arrange carer administration of trial drug.

Documented informed consent to participate.

Exclusion Criteria:

Diagnosis or suspicion of other cause for parkinsonism.

Body mass index <18.5.

Known abnormality on CT or MRI brain imaging considered likely to compromise compliance with trial protocol/DaTSCAN acquisition.

Concurrent dementia defined by a score lower than 120 on the Mattis Dementia Rating Scale.

Concurrent severe depression defined by a score >16 on the MADRS.

Prior intra-cerebral surgical intervention for Parkinson's disease.

Already actively participating in a trial of a device, drug or surgical treatment for Parkinson's disease.

Severe gastrointestinal disease (e.g. gastroparesis).

Previous exposure to Exenatide.

Severely impaired renal function with creatinine clearance <30ml/min.

History of pancreatitis.

Hyperlipidaemia.

History or suspicion of thyroid cancer

Known or suspected intolerance of DaTSCAN or Potassium Iodide administration.

Females that are pregnant or breast feeding.

Participants who lack the capacity to give informed consent

Any medical or psychiatric condition which in the investigator's opinion compromises the potential participant's ability to participate.