Precision medicine approach for diagnosing and treating Parkinson's, Alzheimer's, and type 2 diabetes
NEUROTECHNO: Precision Medicine and Neurodegenerative Diseases: Advanced Systems for the Diagnosis and Treatment of Parkinson's Disease and Alzheimer's Disease.
Neuromed IRCCS · NCT07467460
This project will test whether genetic, metabolic, epigenetic and brain-imaging patterns can help diagnose and guide care for people with Parkinson's disease, Alzheimer's disease, or type 2 diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Neuromed IRCCS (other) |
| Locations | 1 site (Pozzilli) |
| Trial ID | NCT07467460 on ClinicalTrials.gov |
What this trial studies
This is a multicenter observational project led by IRCCS Neuromed with collaborating Italian research institutes that combines clinical data, multi-omics (genetic, metabolic, epigenetic), and neuroimaging. The team will analyze existing well-characterized Parkinson's samples and recruit and classify additional Parkinson's and Alzheimer's patients, with attention to the presence or absence of type 2 diabetes. Collected materials include DNA, serum, plasma, PBMCs and available induced pluripotent stem cells, alongside standardized clinical and imaging assessments. The goal is to identify minimally invasive peripheral or structural biomarkers and integrated profiles that distinguish disease subtypes and metabolic comorbidities.
Who should consider this trial
Good fit: Adults diagnosed with Parkinson's disease or Alzheimer's disease, including those with or without type 2 diabetes, who can provide consent, blood samples, and undergo clinical assessments and neuroimaging are ideal candidates.
Not a fit: People with atypical or secondary parkinsonism, those unable to undergo imaging or blood draws, or individuals without confirmed diagnoses are unlikely to benefit from this observational project.
Why it matters
Potential benefit: If successful, the work could lead to blood or imaging biomarkers that enable earlier diagnosis and more personalized care for people with Parkinson's disease or Alzheimer's disease, especially those with type 2 diabetes.
How similar studies have performed: Previous multi-omics and neuroimaging studies have produced promising candidate biomarkers but clinical translation remains limited, so this project builds on promising but not yet definitive prior work.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. Presence of at least 2 of the 4 cardinal signs (tremor, rigidity, bradykinesia, asymmetric onset), one of which must be tremor or bradykinesia: Absence of atypical symptoms such as: i) early postural instability, freezing episodes, cognitive decline, hallucinations, pathological involuntary movements, vertical gaze palsy; ii) confirmed causes of secondary parkinsonism (focal lesions, medications, toxic substances); Documented response to L-dopa or dopamine agonists (or lack of an adequate therapeutic trial with L-dopa or dopamine agonists). -Inclusion criteria forAD patients. For the University of Campania, patients will be selected at the Department of Advanced Medical and Surgical Sciences of the University of Campania "L. Vanvitelli," located at Piazza Miraglia 2, Naples. The Department will establish a collaboration with the Alzheimer's day centers of ASL NA1 (Geriatric Facility "Villa Walpole" - Via Ponti Rossi, 118 - Naples, and Geriatric Facility "Frullone" - Via Comunale del Principe, 16/A - Naples) to identify potential subjects for screening to verify the parameters required for recruitment. The Geriatrics and Internal Medicine Unit (UOC), AOU University of Campania, will also be involved. Patients with AD will be included following a diagnosis of probable Alzheimer's disease according to the McKhann criteria (2011), supported by positive biomarkers for amyloidopathy (amyloid PET or cerebrospinal fluid amyloid assay). Exclusion Criteria: * Pre-existing psychiatric disorders; * Neurodegenerative neurological diseases such as multiple sclerosis, amyotrophic lateral sclerosis, Alzheimer's disease, neuromuscular disorders, epilepsy; * Diagnosis of dementia.
Where this trial is running
Pozzilli
- IRCCS INM Neuromed — Pozzilli, Italy (RECRUITING)
Study contacts
- Principal investigator: TERESA ESPOSITO, PhD — IRCCS INM Neuromed
- Study coordinator: Teresa Esposito, PhD
- Email: teresa.esposito@igb.cnr.it
- Phone: +39 0865915249
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: PARKINSON DISEASE, Alzheimer s Disease, Diabete Type 2, Identification of genetic and metabolic profiles associated with neurodegenerative diseases, Identification of epigenetic profiles associated with neurodegenerative diseases, Integration and analysis of omics and neuroimaging data