Omics-based profiling to find disease mechanisms and biomarkers in Alzheimer’s, Parkinson’s, FTD, and related dementias

Omics Sciences for the Identification of Pathogenetic Mechanisms and Biomarkers in Neurodegenerative Diseases

This project will use advanced omics tests (genetics, gene expression, proteins, and metabolites) to try to find biological markers and disease mechanisms in people with Alzheimer’s, Parkinson’s, frontotemporal and young-onset dementias, or mild cognitive impairment.

Quick facts

• Study type: Observational
• Enrollment: 1200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ospedale Policlinico San Martino (Academic / other)
• Locations: 1 site (Genoa, Genoa)
• Trial ID: NCT07235111 on ClinicalTrials.gov

What this trial studies

This observational project will enroll at least 1,200 patients with Alzheimer’s disease, Parkinson’s disease, frontotemporal dementia, mild cognitive impairment, and young-onset dementia from major Italian centers. Researchers will collect peripheral biological samples and integrate genomic, transcriptomic, epigenomic, proteomic, metabolomic, and clinical data to more completely characterize disease pathways and identify candidate biomarkers. Participants are identified during routine outpatient visits and no investigational treatments are given. The aim is to discover markers useful for diagnosis, prognosis, monitoring, and predicting response to therapy.

Who should consider this trial

Good fit: Adults diagnosed with Alzheimer’s disease, Parkinson’s disease, frontotemporal dementia, Lewy body disease, young-onset dementia, or mild cognitive impairment who can consent and attend participating Italian centers are ideal candidates.

Not a fit: People without a diagnosed neurodegenerative disorder, those unable or unwilling to provide biological samples, or those seeking immediate therapeutic benefit are unlikely to gain direct clinical benefit from participating.

Why it matters

Potential benefit: If successful, this work could enable earlier and more accurate diagnosis, better prediction of disease course and treatment response, and more personalized care for people with neurodegenerative diseases.

How similar studies have performed: Previous omics studies in neurodegeneration have identified promising candidate biomarkers and pathways, but large integrated datasets with clinical validation are still limited, so this approach is promising but not yet proven.

Eligibility criteria

Inclusion Criteria

• Patients suffering from neurodegenerative diseases

Exclusion Criteria

• Patients not suffering from neurodegenerative diseases

Where this trial is running

Genoa, Genoa

• Ospedale Policlinico San Martino — Genoa, Genoa, Italy (Recruiting)

Study contacts

• Study coordinator: Paola Mandich, MD, PhD

Conditions Alzheimer Disease; FTD; Young-onset Dementia; MCI; Parkinson Disease; ALS; LEWY BODIES DISEASE; young-onset dementia