NCT07467460 Precision Medicine and Neurodegenerative Diseases: Advanced Systems for the Diagnosis and Treatment of Parkinson's Disease and Alzheimer's Disease.
| NCT ID | NCT07467460 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Neuromed IRCCS |
| Condition | PARKINSON DISEASE (Disorder) |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2026-02-17 |
| Primary Completion | 2028-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2026-02-17 with a primary completion date of 2028-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In recent decades, advances in medicine have significantly improved both quality of life and life expectancy. However, these positive effects are also associated with a considerable increase in the prevalence of age-related diseases. Among these, Alzheimer's disease (AD), Parkinson's disease (PD), and type 2 diabetes (T2D) currently represent a major threat to human health. PD and AD are the most common neurodegenerative diseases in industrialized populations. In particular, AD accounts for 54% of all cases of dementia, with a prevalence of 4.4% among individuals over 65 years of age. PD has a prevalence of about 1% in people older than 60 years, reaching up to 4% in those over 80 years of age. AD and PD are highly disabling disorders with a slow but progressive course, caused by the degeneration and/or death of nerve cells. This results in impairments in the control of movement and balance, as in the case of PD, or in cognitive functioning, as in AD. To date, neither effective treatments nor early diagnostic tools are available to address these conditions in the initial phase of neurodegeneration. Likewise, there are no tools capable of monitoring disease progression and improving patients' adaptation to therapy. Moreover, although the association between T2D and the risk of PD and/or AD has long been recognized, these conditions were historically considered unrelated. Recent evidence from clinical and epidemiological studies suggests the existence of shared pathophysiological mechanisms associated with insulin resistance and persistent inflammation in several metabolically relevant tissues, such as adipose tissue and the brain. However, the mechanisms that increase the risk of PD and/or AD in individuals with T2D remain poorly understood. These data highlight how relevant these diseases are for the National Health System and demonstrate that they represent one of the most important priorities to be addressed, requiring substantial investments in both scientific research and early diagnostic strategies. Therefore, the present project proposal, which aims to develop new minimally invasive tools for the early prediction and monitoring of neurodegenerative diseases such as AD and PD, will help fill an important gap in the clinical and therapeutic management of these patients.
Eligibility 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.
Contact & Investigator
TERESA ESPOSITO, PhD
PRINCIPAL INVESTIGATOR
IRCCS INM Neuromed
Frequently Asked Questions
Who can join the NCT07467460 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying PARKINSON DISEASE (Disorder). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07467460 currently recruiting?
Yes, NCT07467460 is actively recruiting participants. Contact the research team at teresa.esposito@igb.cnr.it for enrollment information.
Where is the NCT07467460 trial being conducted?
This trial is being conducted at Pozzilli, Italy.
Who is sponsoring the NCT07467460 clinical trial?
NCT07467460 is sponsored by Neuromed IRCCS. The principal investigator is TERESA ESPOSITO, PhD at IRCCS INM Neuromed. The trial plans to enroll 500 participants.
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