Parkinsons Disease (PD)NEU-PDNCT07681219
LRRK2 (Leucine-Rich Repeat Kinase 2) Parkinson's Disease Fingerprint
A study testing The interventions of the study are the study of blood biomarkers and neuroimaging and neurophysiological data in people with Parkinsons Disease (PD) and LRRK2, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
The goal of this interventional monocentric study is to identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis and deep clinical phenotyping. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinsons Disease (PD), LRRK2
- What is being tested?
- The interventions of the study are the study of blood biomarkers and neuroimaging and neurophysiological data
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Sep 2029
- Phase
- Interventional
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 30-80 years,
- clinically established diagnosis of PD according to the Movement Disorders Society (MDS) diagnostic criteria,
- Hoehn \& Yahr (H\&Y) stage between 1 and 3,
- 10 patients with a LRRK2 associated parkinsonism and 10 with sporadic PD tested with a NGS panel and MLPA for PD associated genes,
- ability to provide informed consent.
Who cannot join
- Active or history of other neurological disorders,
- active infectious disease or history within the previous 4 weeks,
- continuative therapy (at least 1 week) with NSAIDs or steroids within the previous 12 weeks,
- active malignancy, autoinflammatory or autoimmune diseases or history within the previous 3 years;
- alcohol or drug abuse or dependence
- any contraindication to the execution of the MRI (including claustrophobia).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: LRRK2 Associated Parkinson's Disease: Definition of a Clinical, Molecular and Neurophysiological Fingerprint
The goal of this interventional monocentric study is to identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis and deep clinical phenotyping. Patients who meet the inclusion criteria, after signing the informed consent form will be clinically evaluated by a neurologist expert in movement disorders. Eventually, patients will undergo a blood sample collection, a brain MRI, and a high density EEG. All data will be collected using an ad hoc electronic Case Report Form (CRF) developed for the study
- Conditions
- Parkinsons Disease (PD), LRRK2
- Being tested
- The interventions of the study are the study of blood biomarkers and neuroimaging and neurophysiological data
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The interventions of the study are the study of blood biomarkers and neuroimaging and neurophysiological dataDiagnostic test
- Blood sample collection and markers analysis
- Brain 1.5 T MRI
- High density EEG
| Study group | Role | What they receive |
|---|---|---|
| Patients who meet the inclusion criteria | Experimental | This is a single arm study. All enrolled patients will receive the same interventions throughout the study. Receives: Diagnostic Test: The interventions of the study are the study of blood biomarkers and neuroimaging and neurophysiological data |
What is being measured
The primary outcome is the main question the study is designed to answer.
1) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping.
Movement Disorders Society- Unified PD Rating Scale (MDS-UPDRS). The scoring basis is 0 to 4. The total score across all parts ranges from 0 (no disability) to 260 (total disability). The higher the score, the more advanced or severe the symptoms are.
Measured: Through the study completion, about 3 years
2) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping.
The Hoehn and Yahr (H\&Y) scale. Stage 0: No signs of disease. Stage 1: Unilateral (one-sided) disease involvement only, with minimal or no functional impairment.
Stage 1.5: Unilateral plus axial (neck/torso) involvement. Stage 2: Bilateral or midline involvement, without impairment of balance. Stage 2.5: Mild bilateral disease, with recovery on the clinical "pull test" (balance reflex assessment).
Stage 3: Mild to moderate bilateral disease; some postural instability, but the patient remains physically independent.
Stage 4: Severe disability; however, the patient is still able to walk or stand unassisted.
Stage 5: Wheelchair-bound or bedridden unless aided.
Measured: Through the study completion, about 3 years
3) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping.
Unified dyskinesia rating scale (UDysRS). Scoring uses a 0 to 4 Likert-type scale, where higher scores indicate greater dyskinesia severity and impairment.
Measured: Through the study completion, about 3 years
4) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping.
Non-Motor symptoms scale (NMSS). Each of the 30 items is scored by multiplying its severity (0-3) by its frequency (1-4), yielding a possible subscore from 0-12 per item and a total score ranging from 0 to 360.
Severity: 0 = None, 1 = Mild: symptoms present but causes little distress or disturbance to patient; 2 = Moderate: some distress or disturbance to patient; 3 = Severe: major source of distress or disturbance to patient.
Frequency: 1 = Rarely (<1/wk); 2 = Often (1/wk); 3 = Frequent (several times per week); 4 = Very Frequent (daily or all the time).
Measured: Through the study completion, about 3 years
5) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping.
Montreal Cognitive Assessment (MoCA). Total Score: 30 points possible. Normal Result: A score of 26 or higher is typically considered normal.
Measured: Through the study completion, about 3 years
6) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping.
Mini Mental status evaluation (MMSE). While the scoring is out of 30 points, results are often categorized to gauge severity:
25-30: Normal cognitive function. 21-24: Mild cognitive impairment. 10-20: Moderate cognitive impairment. Below 10: Severe cognitive impairment.
Measured: Through the study completion, about 3 years
7) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping.
Questionnaire for impulsive-compulsive disorders (QUIP). A rating scale measuring symptom severity. It evaluates 4 primary impulse control disorders (gambling, sexual, buying, eating) and related behaviors, scoring them from 0 to 16 based on thoughts, urges, and difficulty to control.
Measured: Through the study completion, about 3 years
8) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping.
Beck depression inventory (BDI). Each statement is assigned a value from 0 to 3. The scores for all 21 questions are added together to produce a total score between 0 and 63.
Total score:
0 to 13: Minimal depression 14 to 19: Mild depression 20 to 28: Moderate depression 29 to 63: Severe depression
Measured: Through the study completion, about 3 years
9) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping.
Beck Anxiety Inventory (BAI). Scoring basis: ranging from 0 (not at all) to 3 (severely).
Total score:
0-7: Minimal anxiety 8-15: Mild anxiety 16-25: Moderate anxiety 26-63: Severe anxiety
Measured: Through the study completion, about 3 years
10) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping
Molecular markers assessment: A panel of pro- and anti-inflammatory mediators will be analysed (IL1-b, TNFa, IFNg, IL4, IL5, IL6, IL17, IL10) along with Neurofilament light chain. The unit of measure is pg/mL.
Measured: Through the study completion, about 3 years
Secondary outcomes (2)
1) Mechanistic Modeling of LRRK2-Associated Parkinson's Disease
IDENTIFY relevant data features (months 12-36). This task seeks to map large-scale brain dynamics (EEG-derived metrics) to symptoms-related changes in idiopathic PD (Parkinson's Disease) vs LRRK2-PD, before and after dopaminergic therapy. The success of task one will be evaluated on the predictive power of the EEG-derived metrics to distinguish ON/OFF, LRRK2/Idiopathic patients and to predict clinical symptoms.
Measured: Through study completion, about 3 years
2) Mechanistic Modeling of LRRK2-Associated Parkinson's Disease
PREDICT such changes using patient-specific in silico models (months 12-36). This task aims to develop a mechanistic model that simulates the effects of changes in Protocol NEU-PD V.1.0 of 05th May 2026 Pag. 7 | 10 activities in the SPNs (i.e. firing rate, spontaneous excitability - glutamatergic activity) on the whole-brain dynamics at the individual level. A brain model consists of a set of equations that encapsulate pathophysiological knowledge and patient-specific features. Solving the model generates patient-specific synthetic brain data. In these models the brain is parceled in a set of regions based on anatomo-functional atlases. Each node is informed with specific features that determine the local activities. In-silico simulations allow to infer how large-scale dynamics emerge from the interaction of local properties. The success of this task will be measured by the model's ability to reproduce conditionspecific (LRRK2/PD) EEG signal features.
Measured: Through the study completion, about 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinsons Disease (PD)Studies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study is considered interventional, as the interventions of the study which are the study of blood biomarkers and neuroimaging and neurophysiological data, do not enter in normal clinical practice.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Di Lazzaro Giulia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681219
- Sponsor's protocol ID
- 27556
- Acronym
- NEU-PD
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data gathered in accordance with the protocol will be inserted in the eCRF (electronic Case Report Form) made for this study. Analyzed data will be shared through publications.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LRRK2 Associated Parkinson's Disease: Definition of a Clinical, Molecular and Neurophysiological Fingerprint
- ClinicalTrials.gov ID
- NCT07681219
- Acronym / sponsor ID
- NEU-PD / 27556
- Conditions
- Parkinsons Disease (PD), LRRK2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 2 Jul 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.
The goal of this interventional monocentric study is to identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis and deep clinical phenotyping. Patients who meet the inclusion criteria, after signing the informed consent form will be clinically evaluated by a neurologist expert in movement disorders. Eventually, patients will undergo a blood sample collection, a brain MRI, and a high density EEG. All data will be collected using an ad hoc electronic Case Report Form (CRF) developed for the study
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is considered interventional, as the interventions of the study which are the study of blood biomarkers and neuroimaging and neurophysiological data, do not enter in normal clinical practice.
| Arm | Type | Receives |
|---|---|---|
| Patients who meet the inclusion criteria | Experimental | Diagnostic Test: The interventions of the study are the study of blood biomarkers and neuroimaging and neurophysiological dataThis is a single arm study. All enrolled patients will receive the same interventions throughout the study. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 30-80 years,
- clinically established diagnosis of PD according to the Movement Disorders Society (MDS) diagnostic criteria,
- Hoehn \& Yahr (H\&Y) stage between 1 and 3,
- 10 patients with a LRRK2 associated parkinsonism and 10 with sporadic PD tested with a NGS panel and MLPA for PD associated genes,
- ability to provide informed consent.
Key exclusion criteria (6 listed)
- Active or history of other neurological disorders,
- active infectious disease or history within the previous 4 weeks,
- continuative therapy (at least 1 week) with NSAIDs or steroids within the previous 12 weeks,
- active malignancy, autoinflammatory or autoimmune diseases or history within the previous 3 years;
- alcohol or drug abuse or dependence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The interventions of the study are the study of blood biomarkers and neuroimaging and neurophysiological data* Blood sample collection and markers analysis * Brain 1.5 T MRI * High density EEG | Diagnostic test | Patients who meet the inclusion criteria |
Primary outcome
1) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping.
Time frame: Through the study completion, about 3 years
Movement Disorders Society- Unified PD Rating Scale (MDS-UPDRS). The scoring basis is 0 to 4. The total score across all parts ranges from 0 (no disability) to 260 (total disability). The higher the score, the more advanced or severe the symptoms are.
2) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping.
Time frame: Through the study completion, about 3 years
The Hoehn and Yahr (H\&Y) scale. Stage 0: No signs of disease. Stage 1: Unilateral (one-sided) disease involvement only, with minimal or no functional impairment. Stage 1.5: Unilateral plus axial (neck/torso) involvement. Stage 2: Bilateral or midline involvement, without impairment of balance. Stage 2.5: Mild bilateral disease, with recovery on the clinical "pull test" (balance reflex assessment). Stage 3: Mild to moderate bilateral disease; some postural instability, but the patient remains physically independent. Stage 4: Severe disability; however, the patient is still able to walk or stand unassisted. Stage 5: Wheelchair-bound or bedridden unless aided.
3) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping.
Time frame: Through the study completion, about 3 years
Unified dyskinesia rating scale (UDysRS). Scoring uses a 0 to 4 Likert-type scale, where higher scores indicate greater dyskinesia severity and impairment.
4) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping.
Time frame: Through the study completion, about 3 years
Non-Motor symptoms scale (NMSS). Each of the 30 items is scored by multiplying its severity (0-3) by its frequency (1-4), yielding a possible subscore from 0-12 per item and a total score ranging from 0 to 360. Severity: 0 = None, 1 = Mild: symptoms present but causes little distress or disturbance to patient; 2 = Moderate: some distress or disturbance to patient; 3 = Severe: major source of distress or disturbance to patient. Frequency: 1 = Rarely (<1/wk); 2 = Often (1/wk); 3 = Frequent (several times per week); 4 = Very Frequent (daily or all the time).
5) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping.
Time frame: Through the study completion, about 3 years
Montreal Cognitive Assessment (MoCA). Total Score: 30 points possible. Normal Result: A score of 26 or higher is typically considered normal.
6) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping.
Time frame: Through the study completion, about 3 years
Mini Mental status evaluation (MMSE). While the scoring is out of 30 points, results are often categorized to gauge severity: 25-30: Normal cognitive function. 21-24: Mild cognitive impairment. 10-20: Moderate cognitive impairment. Below 10: Severe cognitive impairment.
7) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping.
Time frame: Through the study completion, about 3 years
Questionnaire for impulsive-compulsive disorders (QUIP). A rating scale measuring symptom severity. It evaluates 4 primary impulse control disorders (gambling, sexual, buying, eating) and related behaviors, scoring them from 0 to 16 based on thoughts, urges, and difficulty to control.
8) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping.
Time frame: Through the study completion, about 3 years
Beck depression inventory (BDI). Each statement is assigned a value from 0 to 3. The scores for all 21 questions are added together to produce a total score between 0 and 63. Total score: 0 to 13: Minimal depression 14 to 19: Mild depression 20 to 28: Moderate depression 29 to 63: Severe depression
9) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping.
Time frame: Through the study completion, about 3 years
Beck Anxiety Inventory (BAI). Scoring basis: ranging from 0 (not at all) to 3 (severely). Total score: 0-7: Minimal anxiety 8-15: Mild anxiety 16-25: Moderate anxiety 26-63: Severe anxiety
10) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping
Time frame: Through the study completion, about 3 years
Molecular markers assessment: A panel of pro- and anti-inflammatory mediators will be analysed (IL1-b, TNFa, IFNg, IL4, IL5, IL6, IL17, IL10) along with Neurofilament light chain. The unit of measure is pg/mL.
2 secondary outcomes
1) Mechanistic Modeling of LRRK2-Associated Parkinson's Disease
Time frame: Through study completion, about 3 years
2) Mechanistic Modeling of LRRK2-Associated Parkinson's Disease
Time frame: Through the study completion, about 3 years
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 10 Jul 2026.
- Individual participant dataSharing planned: Yes. All data gathered in accordance with the protocol will be inserted in the eCRF (electronic Case Report Form) made for this study. Analyzed data will be shared through publications.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing The interventions of the study are the study of blood biomarkers and neuroimaging and neurophysiological data in people with Parkinsons Disease (PD) and LRRK2, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Giulia Di Lazzaro, MD, PhD, Neurologist (+39 3333310889, giulia.dilazzaro@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping. (time frame: Through the study completion, about 3 years). The study lists 10 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 10 Jul 2026.