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NEUROTECHNO: Precision Medicine and Neurodegenerative Diseases: Advanced Systems for the Diagnosis and Treatment of Parkinson's Disease and Alzheimer's Disease.

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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⁃ 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).

Locations
Other Locations
Italy
IRCCS INM Neuromed
RECRUITING
Pozzilli
Contact Information
Primary
Teresa Esposito, PhD
teresa.esposito@igb.cnr.it
+39 0865915249
Time Frame
Start Date: 2026-02-17
Estimated Completion Date: 2028-09-30
Participants
Target number of participants: 500
Treatments
PD patients
PD participants will be assessed for disease progression, including Hoehn and Yahr stage, MDS-UPDRS Part III, MoCA test, non-motor symptoms, therapy, occurrence of LID, and sleep disorders. Participants will undergo brain magnetic resonance imaging (MRI). Participants will undergo peripheral blood sampling for the isolation of DNA, plasma, serum, and PBMCs, as well as for the generation of hiPSCs. The DNA of each participant will be analyzed by whole-exome sequencing to identify variants in candidate PD genes. DNA will also be analyzed to assess the epigenetic profile. Plasma and serum samples will be analyzed to evaluate metabolomic, lipidomic, and proteomic profiles.
AD patients
AD Partecipants will be assessed for disease progression: - assessment of cognitive disorders (MMSE, MOCA test, clock test); - assessment of language disorders; - current drug therapy (and possible start date of treatment); - date of onset of cognitive disorders; - acquisition and assessment of imaging data where present (MRI, CT, PET). Participants will undergo peripheral blood sampling for the isolation of DNA, plasma, serum. The DNA of each participant will be analyzed by whole-exome sequencing to identify variants in candidate AD genes. DNA will also be analyzed to assess the epigenetic profile. Plasma and serum samples will be analyzed to evaluate metabolomic, lipidomic, and proteomic profiles.
Type 2 Diabetes (T2D) patients
T2D Partecipants will be assessed for disease progression. Participants will undergo peripheral blood sampling for the isolation of DNA, plasma, serum. The DNA of each participant will be analyzed by whole-exome sequencing to identify variants in candidate T2D genes. DNA will also be analyzed to assess the epigenetic profile. Plasma and serum samples will be analyzed to evaluate metabolomic, lipidomic, and proteomic profiles.
Sponsors
Collaborators: Istituto degli Endotipi in Oncologia, Metabolismo e Immunologia G. Salvatore (IEOMI), CNR, Istituto di Genetica e Biofisica A. Buzzati Traverso, CNR, Istituto di Calcolo e Reti ad Alte Prestazioni (ICAR), CNR, University of Campania Luigi Vanvitelli
Leads: Neuromed IRCCS

This content was sourced from clinicaltrials.gov