Clinical Trials Logo

Clinical Trial Summary

The AETIONOMY project will generate a refined taxonomy and testable mechanisms underlying the derived stratification of patients.


Clinical Trial Description

The main objective of the AETIONOMY clinical study is to test in real clinical samples the validity of the hypothesized underlying pathogenic mechanisms of AD and PD. Although not fully understood, the pathophysiology of neurodegenerative diseases results from the complex interplay between several biological pathways such as neuronal excitotoxicity, oxidative stress, protein miss-folding and aggregation, neuroinflammation, apoptosis etc. It is thus likely that the maps generated by the AETIONOMY project will comprise several distinct biological hypotheses and subgroups of patients defined by 1 or more of these hypotheses. The Consortium has insufficient resources to validate all these hypotheses. Although it is anticipated that the AETIONOMY Project will provide novelty in the investigators' understanding of neurodegenerative diseases, it is expected that previously known biological pathways will come out from the data mining approach, e.g. mitochondrial pathway for PD or beta-amyloid aggregation for AD. AETIONOMY project will take advantage of these previously known pathways that will be considered as internal controls. One or two novel pathogenic pathways will be tested in parallel. Overall, this strategy will allow validating two hypotheses for each neurodegenerative disease (AD and PD). As it cannot be predicted what hypotheses will precisely rise from the data mining, the approach must be adaptative. However, it is possible to anticipate which population, clinical data, brain imaging procedure, and which biological samples will have to be applied for their validation. The AETIONOMY clinical study thus aims at assembling a standardized clinical, brain imaging, and biological collection from AD patients, PD patients and healthy controls to validate the model proposed by the AETIONOMY project. The Consortium will identify potential pathogenic pathways (established and novel) involved in AD and PD and will deliver surrogate markers which serve as readouts of the involved pathways. The model will be considered validated if the selected makers allow subject stratification in the AETIONOMY clinical study according to what has been postulated in the model. Additional correlation between biomarker expression and brain imaging will be performed when available. A transversal cohort will be recruited from 4 sites in Europe (France, Germany, Spain, and Sweden), including AD and PD patients, individuals at risk of AD and PD, and healthy controls. Approximately 655 subjects will be recruited. Subjects will have a single study visit with clinical assessments, biological sampling, brain imaging (AD group only). Standardized procedures will be used for biological sampling as well as for brain image acquisition. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05040048
Study type Observational
Source Institut National de la Santé Et de la Recherche Médicale, France
Contact
Status Completed
Phase
Start date September 4, 2015
Completion date February 2018

See also
  Status Clinical Trial Phase
Completed NCT02915848 - Long-term Stability of LFP Recorded From the STN and the Effects of DBS
Recruiting NCT03648905 - Clinical Laboratory Evaluation of Chronic Autonomic Failure Phase 1
Terminated NCT02688465 - Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE). Phase 4
Not yet recruiting NCT04933513 - Development and Validation of a Scale Measuring Preoperative Expectations in Parkinson's Disease
Completed NCT02562768 - A Study of LY3154207 in Healthy Participants and Participants With Parkinson's Disease Phase 1
Completed NCT00105508 - Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia Phase 3
Completed NCT00105521 - Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia Phase 3
Completed NCT02236260 - Evaluation of the Benefit Provided by Acupuncture During a Surgery of Deep Brain Stimulation N/A
Completed NCT03703570 - A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing Preparations Phase 2
Completed NCT03462680 - GPR109A and Parkinson's Disease: Role of Niacin in Outcome Measures N/A
Completed NCT02837172 - Diagnosis of PD and PD Progression Using DWI
Not yet recruiting NCT04735172 - Exploration of Differences in Metabolite Concentrations by 7Teslas NMR Spectroscopy in Striatum and Subthalamic Nuclei in de Novo Parkinsonian Patients and Control Subjects N/A
Not yet recruiting NCT04046276 - Intensity of Aerobic Training and Neuroprotection in Parkinson's Disease N/A
Recruiting NCT02927691 - Novel Management of Airway Protection in Parkinson's Disease: A Clinical Trial Phase 2
Recruiting NCT02952391 - Assessing Cholinergic Innervation in Parkinson's Disease Using the PET Imaging Marker [18F]Fluoroethoxybenzovesamicol N/A
Active, not recruiting NCT02937324 - The CloudUPDRS Smartphone Software in Parkinson's Study. N/A
Terminated NCT02894567 - Evaluation of Directional Recording and Stimulation Using spiderSTN N/A
Completed NCT02874274 - Vaccination Uptake (VAX) in PD N/A
Terminated NCT02924194 - Deep Brain Stimulation of the nbM to Treat Mild Cognitive Impairment in Parkinson's Disease N/A
Completed NCT02939391 - A Study of KW-6356 in Subjects With Early Parkinson's Disease Phase 2