Actively Recruiting
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
Led by Neuromed IRCCS · Updated on 2025-03-18
110
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
Sponsors
N
Neuromed IRCCS
Lead Sponsor
U
Università del Piemonte Orientale AOU Maggiore della Carità - Novara
Collaborating Sponsor
AI-Summary
What this Trial Is About
Neurodegenerative disorders (NDDs), such as Parkinson¿s disease (PD), Alzheimer¿s disease (AD), Frontotemporal dementia (FTD) and Amyotrophic Lateral Sclerosis (ALS) are characterized by aggregation and intracellular accumulation of misfolded proteins, which are believed to play a key role in synaptic dysfunction and neuronal death. Protein structural complexes in biofluids have been proposed to mirror pathological conditions suggesting their use as biomarkers for NDDs characterized by protein aggregation. In this framework, we plan to: i) collect a large cohort of NDD and prodromal patients and healthy subjects using standardized clinical and genetics procedures; ii) apply a novel method based on genomics, proteomics and bioinformatic analysis to map protein complexes in biofluids; iii) identify novel circulating biomarkers and correlate them to genetic profiling and disease endophenotypes, and; iv) validate the biological properties in human brain tissue and dopaminergic cultures.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parkinson's disease patients must have at least two of the four cardinal signs (tremor, rigidity, bradykinesia, asymmetric onset), including tremor or bradykinesia
- Parkinson's disease patients must have no atypical symptoms like early postural instability, cognitive deterioration, hallucinations, or secondary parkinsonism causes
- Parkinson's disease patients must show response to Levodopa or dopamine agonists or have had adequate therapeutic attempts
- Alzheimer's disease patients must have probable Alzheimer's diagnosis supported by positive amyloid biomarkers
- Amyotrophic Lateral Sclerosis patients must have definite or probable diagnosis per El Escorial criteria (2015)
- Frontotemporal Dementia patients must have diagnosis per Rascovsky criteria (2011) with negative amyloid biomarkers
- Patients with both ALS and FTD must meet El Escorial and Strong criteria
- Patients must be affiliated with specified clinical centers for recruitment
You will not qualify if you...
- Parkinson's disease patients with pre-existing psychiatric conditions
- Parkinson's disease patients with other neurodegenerative diseases or dementia
- Alzheimer's, FTD, or ALS patients with psychiatric pathologies or other neurodegenerative diseases
- Patients unable to provide informed consent
- Control participants with psychiatric disorders, neurodegenerative diseases, dementia, depression, or prolonged use of psychotropic or cognitive drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
IRCCS INM Neuromed
Pozzilli, Italy, Italy, 86077
Actively Recruiting
Research Team
T
Teresa Esposito, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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