Targeting the early pathological pathways in Parkinsons Disease

Study ID: 30509
Short Title: Targeting pathways to Parkinsons
Organisation: Poole Hospital NHS Foundation Trust
Location: Poole General Hospital
Condition: Parkinson's disease
Main Specialty: Neurological disorders
Expected End Date: 30/04/2021
Postcode: BH15 2JB
Contact Name: Sacha Crowley
Contact Email:
Active: Yes

Inclusion Criteria


For PD patients, their relatives, and RBD subjects:

1. Subject is aged > 18 years inclusive and fulfills UK PD Brain Bank criteria for probable Parkinson's Disease (PD patient) or is a first degree relative of a PD patient OR

2. Subject is aged > 18 years inclusive and has a diagnosis of RBD made following overnight sleep studies by a sleep expert/clinician All of the following criteria must apply.

3. Written informed consent obtained from the subject prior to any study-related procedures.

4. Subject is fluent in English.

5. Subject has no evidence for significant cognitive impairment/dementia that would preclude their capacity to make informed decisions on research participation For healthy volunteer subjects:

6. Written informed consent obtained from the subject prior to any study-related procedures.

7. Subject is aged > 18 years inclusive.

8. Subject is fluent in English.

9. Subject has no evidence for significant cognitive impairment/dementia dementia that would preclude their capacity to make informed decisions on research participation.

Exclusion Criteria

For PD patients, PD relatives, RBD subjects and control subjects:

1. Subject has a severe medical or psychiatric illness that would interfere with completing initial and follow-up assessments

2. Subject has severe mental impairment due to dementia or psychosis such that they lack capacity to make informed decisions

3. Active pregnancy For control subjects: (a) Active participation by a control subject in a clinical drug trial

4. Lumbar Puncture Exclusion Criteria (applicable to all study participants): (a) Treatment with blood thinners, e.g. warfarin (b) Coagulation abnormalities known (c) Coagulopathy or platelet counts. 

5. History of chronic or repeat CSF leakage following previous lumbar puncture(s)

6. Active infectious process MRI exclusion criteria (applicable to all study participants): (a) Pacemakers 

(b) Electronically, magnetically and mechanically activated implants (c) Metallic splinters in the eye (d) Ferromagnetic haemostatic clips in the central nervous system (CNS)

7. Any other additional exclusionary factors as indicated in the OCMR Imaging Procedures Manual

8. DaTSCAN exclusion criteria (applicable to all study participants): (a) Confirmed pregnancy (b) Use of any concomitant medication that is known or suspected to interact with striatal uptake through direct competition with binding of DaTSCAN to the DAT that could not be discontinued for at least 5 half-lives (these include amphetamine, benztropine, bupropion, cocaine, mazindol, methylphenidate, phentermine and sertraline).

Study summary:

Parkinson’s disease (PD) is a progressive, neurodegenerative disorder characterised by the motor symptoms of
resting tremor, rigidity, slowness of movement and poor balance. At the time these symptoms first emerge, and the
clinical diagnosis of PD can be made, approximately 70% of the dopaminergic brain cells have already been
irreversibly lost. Early treatment intervention is likely to have the biggest impact on the course of the disease, however
this is hampered by a lack of certainty about the diagnosis in the early stages when motor symptoms first emerge.

The Discovery cohort established in 2010-2015 facilitated the recruitment and longitudinal assessment of 1100 early
PD, 300 control and 300 individuals at-risk of future PD from the Thames Valley over 5 yrs. Individuals are studied at
baseline and longitudinally every 18 months with standardised clinical assessments and blood tests, with the option
of an additional MRI brain scan, lumbar puncture and skin biopsy. The study aim is to develop biomarkers to facilitate
the earlier diagnosis and disease stratification of PD, supported by the strong multidisciplinary program of the Oxford
Parkinson's Disease Centre (OPDC), that has combined basic and clinical research to establish a major research
centre in PD with an international reputation. An additional 5 years of funding to allow assessment of this cohort from
2015-20 was awarded by Parkinson's UK following scientific review, hence the current ethics application.

Moving forward in the second phase of our research program, we will direct our increased knowledge of disease
mechanisms to develop translational research aimed at changing clinical practice. Critically, our new program will
now target the molecular pathways to Parkinson's exploiting new tools (i) to predict the onset of PD in at-risk
individuals (ii) to stratify the progression of PD following diagnosis and (iii) to identify potential targets and treatments
to prevent the development of PD

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