Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00011260

Trial Description

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Title

The continuum between healthy ageing and idiopathic Parkinson Disease within a propagation perspective of inflammation and damage: the search for new diagnostic, prognostic and therapeutic targets. Phase 2

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Trial Acronym

PROPAG-AGEING - Phase 2

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URL of the Trial

https://www.propag-ageing.eu/

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Brief Summary in Lay Language

Ageing is the major risk factor for idiopathic Parkinson’s disease, the first motor neurodegenerative disorder (in EU 1% in 65+; about 4% in 80+). Recent researches demonstrate that Parkinson’s disease and ageing share several features, suggesting that this pathology could be the consequence of a “deviation” from the physiological patterns of the ageing process.
The goal of PROPAG-AGEING project is to compare Parkinson’s disease patients with subjects that have successfully aged (nonagenarians and centenarians) in order to identify new molecular profiles for early diagnosis and therapy (identification of druggable targets) of the disease. During Phase 1, PROPAG-AGEING researchers will use the most advanced biomolecular and analytical approaches to analyse samples from cohorts previously recruited in Italy, Germany, UK, Spain and Swedish (including Parkinson’s disease patients, healthy controls and centenarians). Phase 1 will be followed by Phase 2 , when the same analysis will be performed in a newly recruited cohort including siblings of Parkinson’s disease patients. PROPAG-AGEING project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 634821.

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Brief Summary in Scientific Language

Ageing is the major risk factor for idiopathic Parkinson’s disease (PD), the first motor neurodegenerative disorder (in EU 1% in 65+; about 4% in 80+). Despite this evidence, the relationship between the cellular/molecular alterations of physiological/healthy ageing and those underpinning PD pathogenesis are unclear. The most recent data and conceptualizations indicate that ageing and PD share basic characteristics such as accumulation of senescent cells, inflammation and propagation phenomena. Thus, to fully understand PD pathogenesis and set up innovative neuro-protective therapies it is mandatory to posit PD within the framework of ageing process.
The main goal of PROPAG-AGEING is to identify specific cellular and molecular perturbations deviating from healthy ageing trajectories towards PD. To this aim, PROPAG-AGEING Phase 1 (DRKS-ID: DRKS00009427) is analyzing data and biological specimens from large existing cohorts, previously recruited by project partners in Italy, Germany, UK, Spain and Sweden, that include PD patients, healthy controls and centenarian subjects. During Phase 2, the clinical/cellular/molecular markers emerged from Phase 1 will be tested in a newly recruited cohort of subjects not affected by PD at the time of recruitment but possibly showing more risk factors for PD compared to the general population. This cohort will be recruited by 4 PROPAG-AGEING partners: Azienda Unità Sanitaria Locale di Bologna – Istituto delle Scienze Neurologiche di Bologna (AUSL-ISNB, Italy), Universitätsmedizin Göttingen (UMG-GOE, Germany), Servicio Andaluz de Salud (SAS, Spain), and University College of London (UCL, UK). Since family history of PD is associated with an increased risk of developing PD, the healthy siblings of PD patients will be recruited. Each subject will be clinically characterized, including tests for the most common non-motor symptom of PD, that are known to precede the motor dysfunction by more than a decade (RBD, hyposmia, constipation). The sibling cohort will be subdivided into a REM-sleep-behavior-disorder (RBD) positive and negative group, as RBD increases the risk of developping a neuodegenerative disorder in the future. Whole blood, urines and faeces will be collected from each subject. In addition, the gut microbiota of recruited subjects will be evaluated to test the hypothesis that a gut-brain axis (e.g., inflammatory and metabolic stimuli from the gut) can contribute to PD pathogenesis. In the context of the same project, University College of London (UCL, UK) will recruit a small cohort of 20 individuals characterized by known mutations in PD risk genes (such as LRKK2, SNCA or GBA) but not fulfilling the UK Brain Bank Criteria for PD. Also this cohort will be evaluated for candidate PD biomarkers and for gut microbiota.

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Organizational Data

  •   DRKS00011260
  •   2016/11/09
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  •   yes
  •   Approved
  •   16018, COMITATO ETICO INTERAZIENDALE BOLOGNA-IMOLA
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Secondary IDs

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Health Condition or Problem studied

  •   G20.9 -  [generalization G20: Parkinson disease]
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Interventions/Observational Groups

  •   Healthy siblings of Parkinson Disease patients, subdivided into a RBD-positive and -negative group, will be evaluated for the presence of clinical/neurological and molecular (genetic, epigenetic, transcriptomic, glycomic, proteomic, metabolomic, lipidomic) markers of Parkinson Disease emerged from Phase 1 of the project.
  •   Parkinson Diesease patients already analysed in Phase 1 of the study
  •   Healthy controls already analysed in Phase 1 of the study
  •   Long-lived subjects already analysed in Phase 1 of the study
  •   Swedish twins, of whom one twin has PD, already analyzed in Phase 1
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
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  •   Historical, Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

To validate biomarkers for early diagnosis of Parkinson Disease

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Italy
  •   Germany
  •   United Kingdom
  •   Spain
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2016/09/06
  •   560
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1.Siblings of patients with a diagnosis of sporadic idiopathic Parkinson’s Disease, according to the International Diagnostic Criteria [UK Brain Bank Criteria];
2.signed informed consent

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Exclusion Criteria

1.Diagnosis of sporadic idiopathic Parkinson’s Disease according to the UK Brain Bank Criteria;
2.patients affected by clinically relevant diseases of the Central Nervous System (i.e. Alzheimer’s disease, Vascular Encephalopathies, Multiple Sclerosis, etc.).

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Addresses

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    • IRCCS Istituto delle Scienze Neurologiche di Bologna
    • Via Altura, n 3
    • 40139  Bologna
    • Italy
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    •   +39 051 4996075
    •   +39 051 4996074
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    • IRCCS Istituto delle Scienze Neurologiche di Bologna
    • Ms.  Dr.  Federica  Provini 
    • Via Altura, n 3
    • 40139  Bologna
    • Italy
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    • IRCCS Istituto delle Scienze Neurologiche di Bologna
    • Prof.  Claudio  Franceschi 
    • Via Altura, n 3
    • 40139  Bologna
    • Italy
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    • IRCCS Istituto delle Scienze Neurologiche di Bologna
    • Prof.  Claudio  Franceschi 
    • Via Altura, n 3
    • 40139  Bologna
    • Italy
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Sources of Monetary or Material Support

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    • European Union’s Horizon 2020 research and innovation programme
    • Rue du Champs de Mars 02/11
    • 1049  Bruxelles
    • Belgium
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Status

  •   Recruiting complete, follow-up complete
  •   2019/01/22
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.