RecruitingNot Applicable

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

Italy110 participantsStarted 2025-02-04

Plain-language summary

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.

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This study seems focused on collecting biological samples like blood and cerebrospinal fluid to discover new biomarkers — does that mean it's a research and observation study rather than one that offers a new treatment, and what would actual participation involve day-to-day for me?
2Since the trial is looking at protein complexes in spinal fluid (CSF), does that mean I would need to undergo a lumbar puncture, and given my current health status, is that a procedure my care team would be comfortable with me having?
3The study covers four different conditions — Parkinson's, ALS, FTD, and Alzheimer's — so would my specific diagnosis and stage of disease, including where I fall on the Hoehn and Yahr or MDS-UPDRS scale, affect whether this study is even looking to include someone like me?
4Because this trial is listed as Phase NA, meaning it's a biomarker discovery study rather than a treatment trial, would joining it delay or interfere in any way with starting standard treatments that might already be available for my condition?
5The trial mentions genetic analysis to find variants and mutations — is it worth discussing with you what that could mean for me in terms of learning something unexpected about my genetics, and would I receive any of those results?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

motor symptoms of PD patients will be evaluated with Hoehn and Yahr (HY) score

Timeframe: 2 years

motor and non motor symptoms of PD patients will be evaluated with MDS-UPDRS

Timeframe: 2 years

clinical evaluation of cognitive impairment of PD, AD, ALS/FTD patients

Timeframe: 2 years

clinical evaluation of ALS/FTD patients

Timeframe: 2 years

identification of variants/mutations

Timeframe: 2 years

Identification of protein complexes in CSF

Timeframe: 2 years

Bioinformatic analysis for the identification of proteins and molecular pathways involved

Timeframe: 2 years

Trial details

NCT IDNCT06803784

SponsorNeuromed IRCCS

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-08-31

Contact for this trial

Teresa Esposito, PhD

+39 0865915249 teresa.esposito@igb.cnr.it

View on ClinicalTrials.gov More Parkinson Disease trials

Plain-language summary

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

motor symptoms of PD patients will be evaluated with Hoehn and Yahr (HY) score

Timeframe: 2 years

motor and non motor symptoms of PD patients will be evaluated with MDS-UPDRS

Timeframe: 2 years

clinical evaluation of cognitive impairment of PD, AD, ALS/FTD patients

Timeframe: 2 years

clinical evaluation of ALS/FTD patients

Timeframe: 2 years

identification of variants/mutations

Timeframe: 2 years

Identification of protein complexes in CSF

Timeframe: 2 years

Bioinformatic analysis for the identification of proteins and molecular pathways involved

Timeframe: 2 years