PARKINSON DISEASE (Disorder)NEUROTECHNONCT07467460
Precision Medicine and Neurodegenerative Diseases: Advanced Systems for the Diagnosis and Treatment of Parkinson's Disease and Alzheimer's Disease.
An observational study of PARKINSON DISEASE (Disorder) and Alzheimer s Disease, run by Neuromed IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PARKINSON DISEASE (Disorder), Alzheimer s Disease, Diabete Type 2
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 17 Feb 2026to 30 Sep 2028
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- -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).
Who cannot join
- Pre-existing psychiatric disorders;
- Neurodegenerative neurological diseases such as multiple sclerosis, amyotrophic lateral sclerosis, Alzheimer's disease, neuromuscular disorders, epilepsy;
- Diagnosis of dementia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS INM Neuromed
Pozzilli, 86077
Teresa Esposito, PhD, +30 0865915249, teresa.esposito@igb.cnr.it
About this study
Official title: 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.
Read more
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.
Read the 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:
- 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:
- Selection and classification of patients;
- Identification of genetic and metabolic profiles associated with the neurodegenerative diseases under study in a large cohort of patients recruited across the different centers;
- Identification of epigenetic profiles within the same cohort of patients and controls;
- Identification of morphological structures through neuroimaging;
- Integration and analysis of omics and neuroimaging data: identification of altered metabolic pathways and biomarkers (metabolic, epigenetic, morphological) associated with disease prediction and progression;
- Definition of a holistic data model and an acquisition platform capable of capturing and integrating information derived from heterogeneous sources;
- Identification of relevant parameters for monitoring purposes in order to provide information useful for the early diagnosis of risk factors;
- 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.
- 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:
- Design of minimally invasive early-diagnosis kits;
- 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.
- 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).
- Keywords
- 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
- Medical subject headings
- Parkinson Disease, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
motor symptoms of PD patients will be evaluated with Hoehn and Yahr (HY) score
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.
Measured: 3 years
motor and non motor symptoms of PD patients will be evaluated with MDS-UPDRS
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
Measured: 3 years
clinical evaluation of cognitive impairment of PD and AD patients
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.
Measured: 3 years
identification of variants/mutations
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.
Measured: 3 years
Identification of metabolomic, lipidomic and proteomic profiles in plasma/serum
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.
Measured: 3 years
Bioinformatic analysis for the identification of biomarkers and molecular pathways associated with PD and /or AD
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.
Measured: 3 years
Identification of epigenetic profiles in patients with PD, AD, and T2D.
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.
Measured: 3 years
Identification of morphological structures through neuroimaging.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start17 Feb 2026
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Neuromed IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- University of Campania Luigi Vanvitelli, 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
- Responsible party
- Principal investigator, Teresa Esposito, Neuromed IRCCS
- Investigators
- TERESA ESPOSITO, PhD, Principal investigator, IRCCS INM Neuromed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467460
- Sponsor's protocol ID
- F/180029/01-04/X43
- Acronym
- NEUROTECHNO
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEUROTECHNO: Precision Medicine and Neurodegenerative Diseases: Advanced Systems for the Diagnosis and Treatment of Parkinson's Disease and Alzheimer's Disease.
- ClinicalTrials.gov ID
- NCT07467460
- Acronym / sponsor ID
- NEUROTECHNO / F/180029/01-04/X43
- Keywords
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Neuromed IRCCSUniversity, hospital or other
- Collaborators
- University of Campania Luigi Vanvitelli, 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
- Study start
- 17 Feb 2026 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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:
- Selection and classification of patients;
- Identification of genetic and metabolic profiles associated with the neurodegenerative diseases under study in a large cohort of patients recruited across the different centers;
- Identification of epigenetic profiles within the same cohort of patients and controls;
- Identification of morphological structures through neuroimaging;
- Integration and analysis of omics and neuroimaging data: identification of altered metabolic pathways and biomarkers (metabolic, epigenetic, morphological) associated with disease prediction and progression;
- Definition of a holistic data model and an acquisition platform capable of capturing and integrating information derived from heterogeneous sources;
- Identification of relevant parameters for monitoring purposes in order to provide information useful for the early diagnosis of risk factors;
- 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.
- 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:
- Design of minimally invasive early-diagnosis kits;
- 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.
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- -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.
Key exclusion criteria (3 listed)
- Pre-existing psychiatric disorders;
- Neurodegenerative neurological diseases such as multiple sclerosis, amyotrophic lateral sclerosis, Alzheimer's disease, neuromuscular disorders, epilepsy;
- Diagnosis of dementia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
TERESA ESPOSITO, PhD principal investigator
IRCCS INM Neuromed
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PARKINSON DISEASE (Disorder) and Alzheimer s Disease, run by Neuromed IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Teresa Esposito, PhD (+39 0865915249, teresa.esposito@igb.cnr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
motor symptoms of PD patients will be evaluated with Hoehn and Yahr (HY) score (time frame: 3 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.