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

March 9, 2026 updated by: Teresa Esposito, Neuromed IRCCS

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The project is a multicrentric observational study. Institutions involved are:OU1 - IRCCS INM Neuromed; OU2 -University of Campania Luigi Vanvitelli; OU3 -Institute of Genetics and Biophysics Adriano Buzzati-Traverso, CNR; OU4 - Institute of Endotypes in Oncology, Metabolism and Immunology "Gaetano Salvatore" CNR; OU5 -Institute for High Performance Computing and Networking CNR. The project takes advantage from the availability of a large collection of PD samples from familiar and sporadic cases, recruited at IRCCS Neuromed, for which we already collected and stored clinical information, genetic data as well as DNA, serum, plasma and peripheral blood mononuclear cells (PBMCs) for the entire study cohort. induced pluripotent stem cells (iPSC) are available for 6 PD patients and 5 healthy subjects.

The main phases characterizing the project proposal can be summarized as follows:

  1. Industrial research activities:

    In this phase, an in-depth study of clinical characterization will be carried out, together with analyses of metabolic, epigenetic, and morphological (neuroimaging) profiles in selected patients. The aim is to identify new minimally invasive peripheral or structural biomarkers for AD and PD, with or without association with type 2 diabetes.

    Specifically, during this phase the following activities will be carried out:

    1. Selection and classification of patients;
    2. Identification of genetic and metabolic profiles associated with the neurodegenerative diseases under study in a large cohort of patients recruited across the different centers;
    3. Identification of epigenetic profiles within the same cohort of patients and controls;
    4. Identification of morphological structures through neuroimaging;
    5. Integration and analysis of omics and neuroimaging data: identification of altered metabolic pathways and biomarkers (metabolic, epigenetic, morphological) associated with disease prediction and progression;
    6. Definition of a holistic data model and an acquisition platform capable of capturing and integrating information derived from heterogeneous sources;
    7. Identification of relevant parameters for monitoring purposes in order to provide information useful for the early diagnosis of risk factors;
    8. Identification of criteria to be used for risk assessment of the onset of comorbidities, from which appropriate interventions can be defined to properly guide and support the patient.

  2. Experimental Development Activities: Design of diagnostic and disease monitoring tools.

    This phase concerns the design of a potential prototype relevant for the early diagnosis of the neurodegenerative diseases under study and their association with type 2 diabetes. Specifically, in this phase the following activities will be carried out:

    1. Design of minimally invasive early-diagnosis kits;
    2. Design of a system for personalized therapeutic and rehabilitative monitoring of the patient.

    The outcome of this phase will be the definition and selection of all possible technical and scientific solutions required to achieve the established objective.

  3. Prototype Development and Validation:

In this phase, the first complete prototype will be developed. After obtaining and verifying the proper functioning of the prototype, the work will conclude with the evaluation of each procedure performed in order to establish a protocol aimed at supporting the use and application of high-resolution diagnostic kits and monitoring applications within the framework of the National Health System (NHS).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

In this multicenter, observational, prospective study, a total of 500 subjects will be consecutively enrolled at the two clinical recruiting centers involved in the study (IRCCS Neuromed (UO1) and the University of Campania Luigi Vanvitelli (UO2)), including:

100 subjects with Parkinson's disease (PD) (UO1); 50 subjects with PD and diabetes (UO1); 100 subjects with Alzheimer's disease (AD) (UO2); 50 subjects with AD and diabetes (UO2); 50 subjects with diabetes (UO2); 50 first-degree relatives (FDR) of patients with AD or type 2 diabetes (UO2); 100 healthy control subjects for the validation of specific genotypes/epigenotypes and/or biomarkers associated with PD, AD, and/or T2D (UO1 and UO2).

The control subjects will be recruited according to standard clinical practice among patients attending the outpatient clinics of IRCCS Neuromed and the Department of Advanced Medical and Surgical Sciences, University of Campania Luigi Vanvitelli - Naples.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
motor symptoms of PD patients will be evaluated with Hoehn and Yahr (HY) score
Time Frame: 3 years
The Hoehn and Yahr Scale will be used to measure how Parkinson's symptoms progress and the level of disability. Itincludes stages 1 through 5: Stage 1. Unilateral involvement only, usually with minimal or no functional impairment; Stage 2 = Bilateral disease, without impairment of balance; Stage 3 = Mild to moderate bilateral disease; some postural instability; physically independent. Stage 4 = Severe disability; still able to walk or stand unassisted. Stage 5 = Wheelchair bound or bedridden unless aided.
3 years
motor and non motor symptoms of PD patients will be evaluated with MDS-UPDRS
Time Frame: 3 years
The MDS-UPDRS has four parts, namely, I: Non-motor Experiences of Daily Living; II: Motor Experiences of DailyLiving; III: Motor Examination; IV: Motor Complications. Twenty questions are completed by the patient/caregiver
3 years
clinical evaluation of cognitive impairment of PD and AD patients
Time Frame: 3 years
PD patients will be evaluated with the Montreal Cognitive Assessment (MoCA) test. This is a test used by healthcare providers to evaluate people with memory loss or other symptoms of cognitive decline. The MoCA contains 30 questions and checks different types of cognitive or thinking abilities. These include:orientation, short-term memory/delayed recall, executive function/visuospatial ability, clock-drawing test.- assessment of language disorders. AD patients: - assessment of cognitive disorders (MMSE, MOCA test, clock test); - assessment of language disorders.
3 years
identification of variants/mutations
Time Frame: 3 years
PD patients: the number of multiple rare (Minor allele frequency, MAF<0.01) deleterious (missense, non sense, frameshift and splicing) variants in PD genes will be counted in PD patients and unrelated healthy subjects. Case-control assoiciation study will evaluate the PD risk. AD, T2D: deleterious variants (missense, non sense, frameshift and splicing) in responsible genes will be considered.
3 years
Identification of metabolomic, lipidomic and proteomic profiles in plasma/serum
Time Frame: 3 years
Characterization of circulating metabolite, lipid, and protein profiles using an untargeted mass spectrometry (LC-MS) approach in the cohort of patients with PD, AD, and T2D.
3 years
Bioinformatic analysis for the identification of biomarkers and molecular pathways associated with PD and /or AD
Time Frame: 3 years
Through advanced bioinformatics analysis, multivariate statistical analysis techniques and machine learning, metabolites, lipids, proteins and molecular pathways involved in different neurodegenerative diseases and their development will be identified. This will allow us to understand and improve the knowledge of these pathologies and to identify potential therapeutic or diagnostic targets/pathways.
3 years
Identification of epigenetic profiles in patients with PD, AD, and T2D.
Time Frame: 3 years

We will adopt an "epi-genome wide" approach to profile the epigenome of the PD, AD and T2D cohorts using Next Generation Sequencing techniques. Specifically, transcriptomic analyses based on RNA-seq (including microRNA omics) will be performed, and Illumina Infinium Methylation EPIC BeadChips will be used to investigate global DNA methylation.

In this phase of the study, to strengthen the potential preclinical validity for the risk of developing T2D, PD, or AD, an additional analysis of epigenotypes will be conducted on the recruited populations, reclassified according to the presence of obesity, overweight, and/or reduced physical activity.
3 years
Identification of morphological structures through neuroimaging.
Time Frame: 3 years

The patients recruited in the study will undergo advanced magnetic resonance imaging (MRI) studies, in which images will be acquired using the following techniques:

Resting-state functional magnetic resonance imaging (rs-fMRI) Diffusion Tensor Imaging (DTI) Susceptibility Weighted Imaging (SWI) High-resolution 3D T1-weighted structural imaging

The analysis of the results will allow:

Extraction of quantitative morphological-structural parameters at both cortical and subcortical levels; Extraction of quantitative structural connectivity parameters at both cortical and subcortical levels; Extraction of quantitative functional connectivity parameters at both cortical and subcortical levels; Extraction of parameters useful for evaluating metal accumulation or other substances typical of certain pathologies.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Neuromed IRCCS

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Campania Luigi Vanvitelli Dipartimento di Scienze Mediche e Chirurgiche Avanzate
Istituto di Genetica e Biofisica "A. Buzzati Traverso", CNR
Istituto degli Endotipi in Oncologia, Metabolismo e Immunologia "G. Salvatore" (IEOMI), CNR
Istituto di Calcolo e Reti ad Alte Prestazioni (ICAR), CNR

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: TERESA ESPOSITO, PhD, IRCCS INM Neuromed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 17, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • F/180029/01-04/X43

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabete Type 2

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings