Testing blood and fluid protein markers in people with brain-wasting diseases
Studies protein markers in body fluids of people with Parkinson, ALS, dementia.
Key facts
- Who runs it
- Neuromed IRCCS
- Where
- Pozzilli, ItalySee the site
- Trial code
- Registry 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
- Status
- Recruiting
- People taking part
- 110 people, planned
- Started
- 4 Feb 2025
- Expected to end
- Dec 2026
- Type of study
- Observational
- Treatments tested
- Genetic: whole genome sequencing
- whole exome sequencing
- Record updated
- 18 March 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with Parkinson's disease, Alzheimer's disease, frontotemporal dementia or ALS, and also healthy volunteers as controls. Blood and body fluid samples are studied for new disease markers.
- Age
- 20 years and older
- Sex
- All sexes
- Disease stage
- Parkinson's disease: at least 2 of the 4 main signs (tremor, rigidity, slowness of movement, one-sided start), one of them tremor or slowness, and no unusual signs. Alzheimer's disease: probable Alzheimer's with a positive amyloid test (PET scan or spinal fluid). ALS: definite or probable ALS. Frontotemporal dementia: diagnosed by set criteria with a negative amyloid test.
- Earlier treatment
- For Parkinson's disease: a documented response to L-dopa or dopamine agonists, or no adequate trial of them yet.
- Biomarker or test result
- Alzheimer's disease: positive amyloid test (PET scan or spinal fluid). Frontotemporal dementia: negative amyloid test.
Main reasons for not taking part
- Existing psychiatric illness
- Another neurodegenerative disease
- Dementia (Parkinson's patients and controls)
- Cannot sign informed consent (Alzheimer's, frontotemporal dementia and ALS patients)
- Controls: depression or long-term use of anxiety, antidepressant, antipsychotic, sleep or memory-boosting drugs
The registry criteria, word for word
Show all 8 criteriaShow less
Who cannot take part
- AD/FTD/ALS PATIENTS; pre-existing psychiatric pathologies; previous diagnosis of other neurodegenerative neurological diseases; patients unable to sign informed consent
- PD PATIENTS; pre-existing psychiatric pathologies; neurodegenerative neurological diseases such as multiple sclerosis, amyotrophic lateral sclerosis, Alzheimer's, neuromuscular diseases, epilepsy; diagnosis of dementia
- 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
Other 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:
- 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
Where in Italy
- IRCCS INM NeuromedPozzilli, ItalyContact: Teresa Esposito, PhDTaking people
About the trial
What the trial wants to find out
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.
Treatments tested
- Genetic: whole genome sequencing
- whole exome sequencing
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Testing blood and fluid protein markers in people with brain-wasting diseasesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 18 March 2025