Discovery and Validation of Protein Structural Complexes in Circulating Biofluids As Novel Biomarkers for Early Diagnosis, Prognosis and Therapeutic Management of Patients Affected by Neurodegenerative Disorders

Launched by NEUROMED IRCCS · Jan 27, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring new ways to detect and manage neurodegenerative disorders like Parkinson's disease, Alzheimer's disease, Frontotemporal dementia, and Amyotrophic Lateral Sclerosis (ALS). Researchers are investigating proteins found in blood and other bodily fluids that may indicate the presence of these diseases. By collecting samples from people with these conditions, as well as from healthy individuals, they hope to find specific protein markers that could help diagnose these disorders earlier and guide treatment decisions.

To participate, individuals must meet certain criteria based on their diagnosis. For instance, people with Parkinson's disease need to show specific symptoms and respond to a medication called Levodopa. Alzheimer’s patients must have a confirmed diagnosis supported by brain imaging or fluid tests. Those with ALS and Frontotemporal dementia will be included based on specific diagnostic guidelines. Participants can expect to provide blood samples and possibly other biological materials, and their health information will be carefully analyzed. This study aims to improve the understanding of these diseases, which could lead to better treatment options in the future.

Gender

ALL

Eligibility criteria

• * 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.