NCT07480187 · ACTIVE NOT RECRUITING
Toward Molecular Profiling of Parkinson's Disease in Easily Accessible Biological Matrices
This study is testing whether biomarkers found in blood plasma and nasal tissue can accurately profile different neurodegenerative diseases, including Parkinson's and Alzheimer's. Researchers are collecting samples from 340 participants across three Italian centers to see whether these easy-to-obtain samples reflect what is happening in the brain. This is a Phase NA observational study — it collects and measures, it does not test a treatment.
Eligibility criteria
Inclusion Criteria: patients with clinical diagnosis of Parkinson's disease, atypical parkinsonisms, Alzheimer's disease, healthy volunteers, people with subjective cognitive decline. Exclusion Criteria: Other acute neurological diseases or neurodegenerative diseases such as Frontotemporal dementia, vascular dementia, and stroke Relevant comorbidities: chronic kidney disease (significant alteration of blood biomarkers) Skin biopsy: local skin infection at biopsy site, severe dermatologic disease at sampling area, known bleeding disorder, significant thrombocytopenia, anticoagulation not safely manageable, allergy to local anesthetics, poor wound healing, severe peripheral vascular disease, high-risk immunosuppression, inability to consent or cooperate, extensive scarring at intended site Magnetic resonance spectroscopy: non-MRI-compatible implanted device, ferromagnetic intracranial clip, metallic foreign body, severe claustrophobia not manageable, inability to remain still, MRI-conditional device not meeting safety conditions, pregnancy per institutional policy, severe agitation or confusion, body size exceeding scanner limits, severe motion disorder affecting acquisition Venipuncture: refusal or inability to consent, local infection at puncture site, severe coagulopathy, marked thrombocytopenia, high bleeding risk anticoagulation, severe anemia relative to planned blood volume, difficult venous access, history of severe vasovagal syncope Eligibility Criteria Inclusion Criteria: Adults able to provide informed consent Clinical diagnosis of Parkinson's disease Clinical diagnosis of atypical parkinsonism Clinical diagnosis of Alzheimer's disease Individuals with subjective cognitive decline Healthy volunteers Exclusion Criteria: Acute neurological diseases Other neurodegenerative diseases not included in the study groups (e.g., frontotemporal dementia, vascular dementia) History of stroke with significant neurological sequelae Chronic kidney disease with significant alteration of blood biomarkers Procedure-specific exclusion criteria Skin biopsy: Local skin infection at biopsy site Severe dermatologic disease at sampling area Known bleeding disorder Significant thrombocytopenia Anticoagulation not safely manageable Allergy to local anesthetics Poor wound healing Severe peripheral vascular disease High-risk immunosuppression Inability to consent or cooperate Extensive scarring at intended biopsy site Magnetic resonance spectroscopy (MRS): Non-MRI-compatible implanted device Ferromagnetic intracranial clip Metallic foreign body incompatible with MRI Severe claustrophobia not manageable with standard procedures Inability to remain still during MRI acquisition MRI-conditional device not meeting safety conditions Pregnancy according to institutional MRI safety policy Severe agitation or confusion preventing examination Body size exceeding scanner limits Severe motion disorder affecting acquisition Venipuncture: Refusal or inability to provide consent Local infection at puncture site Severe coagulopathy Marked thrombocytopenia High bleeding risk due to anticoagulation Severe anemia relative to planned blood draw volume Difficult venous access History of severe vasovagal syncope during venipuncture Lumbar puncture: Signs of increased intracranial pressure due to mass lesion Local infection at puncture site Uncorrected coagulopathy Severe thrombocytopenia Anticoagulation not safely interruptible Spinal cord compression Unstable spine Refusal or inability to cooperate with the procedure Severe spinal deformity Prior lumbar surgery complicating access Severe anxiety or intolerance to the procedure Pregnancy requiring procedural precautions Nasal brushing: Significant nasal polyposis Severe septal deviation preventing access to the olfactory cleft Active acute or chronic rhinosinusitis Recent epistaxis or bleeding-prone nasal mucosa Nasal lesions, ulcers, or tumors Recent nasal surgery Nasal brushing: Significant nasal polyposis, Severe septal deviation preventing access to the olfactory cleft, Active acute or chronic rhinosinusitis, Recent epistaxis or bleeding-prone nasal mucosa, Nasal lesions, ulcers, tumors, or recent nasal surger
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-03-18