Identifying protein biomarkers in biofluids for neurodegenerative disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to discover and validate protein structural complexes in circulating biofluids as potential biomarkers for early diagnosis, prognosis, and therapeutic management of neurodegenerative disorders such as Parkinson's disease, Alzheimer's disease, Frontotemporal dementia, and Amyotrophic Lateral Sclerosis. The study will involve collecting samples from a large cohort of patients and healthy subjects, utilizing advanced genomics, proteomics, and bioinformatics to analyze protein complexes. The findings will be correlated with genetic profiling and disease characteristics, and validated using human brain tissue and dopaminergic cultures.

Why it matters

Who can join: the full rules

* Inclusion Criteria:
* Inclusion criteria for PD patients.

For the IRCCS INM Neuromed, patients will be recruited from those affiliated with the Center for the Study and Treatment of Parkinson's Disease of the Neuromed Institute of Pozzilli. Affected subjects will be selected according to the criteria proposed by Gelb et al in 1999. This is a very pragmatic scheme based on the presence of four cardinal signs, the response to a test administration of Levodopa and the absence of atypical signs:

A) Presence of at least 2 of the 4 cardinal signs (tremor, rigidity, bradykinesia, asymmetric onset) one of which must be tremor or bradykinesia; B) Absence of atypical symptoms such as: i) early postural instability, freezing phenomena, cognitive deterioration, hallucinations, pathological involuntary movements, vertical gaze paralysis; ii) proven causes of secondary parkinsonism (focal lesions, drugs, toxic substances); C) Documented response to the use of L-dopa or dapamine agonists (or lack of an adequate therapeutic attempt with L-dopa or dopamine agonists).

* Inclusion criteria forAD patients. Patients will be selected at the Center for Cognitive Disorders and Dementias (CDCD) SCDU Neurology, AOU Maggiore della Carità, Novara. Patients with AD will be included after diagnosis of probable Alzheimer's disease according to the McKhann criteria (2011) and supported by positive biomarkers for amyloidopathy (PET with amyloid tracer or amyloid cerebrospinal fluid dosage).
* Inclusion criteria for FTD/ALS patients. For UPO, patients will be selected at the tertiary center Amyotrophic Lateral Sclerosis - SCDU Neurology, AOU Maggiore della Carità, Novara. Patients with amyotrophic lateral sclerosis will be included following a diagnosis according to the El Escorial criteria - revised (2015): in this regard, only patients with a definite or probable diagnosis supported by laboratory will be included. For patients with FTD, they will be selected at both centers mentioned above with a diagnosis according to the Rascovsky criteria (2011). In this group, the diagnosis will be supported by negative biomarkers for amyloidopathy (PET with amyloid tracer or amyloid cerebrospinal fluid dosage). For patients with concomitant ALS and FTD, the El Escorial criteria (2015) associated with the Strong criteria (2017) will be used.

Exclusion Criteria:

* PD PATIENTS

  * pre-existing psychiatric pathologies;
  * neurodegenerative neurological diseases such as multiple sclerosis, amyotrophic lateral sclerosis, Alzheimer's, neuromuscular diseases, epilepsy;
  * diagnosis of dementia;
* AD/FTD/ALS PATIENTS

  * pre-existing psychiatric pathologies;
  * previous diagnosis of other neurodegenerative neurological diseases;
  * patients unable to sign informed consent.
* CONTROLS

  * pre-existing psychiatric pathologies;
  * neurodegenerative neurological diseases such as Parkinson's, multiple sclerosis, amyotrophic lateral sclerosis, Alzheimer's, neuromuscular diseases, epilepsy;
  * diagnosis of dementia;
  * depression;
  * prolonged intake of anxiolytic, antidepressant, antipsychotic, sleep-inducing, cognitive stimulant drugs.

Where it's running

• IRCCS INM Neuromed
  Pozzilli, Italy, Italy Recruiting

Study contacts

• Principal investigator: TERESA ESPOSITO, PhD — IRCCS INM Neuromed
• Study coordinator: Teresa Esposito, PhD
• Email: teresa.esposito@igb.cnr.it
• Phone: +39 0865915249

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.