NCT07480187Active, not recruiting
Toward Molecular Profiling of Parkinson's Disease in Easily Accessible Biological Matrices
Source: ClinicalTrials.gov · Last updated 18 Mar 2026
Brief summary (registry, in English)
Parkinson's disease (PD) is a synucleinopathy and the most common neurodegenerative disease involving disabling motor deficits. PD is clinically heterogeneous; motor symptoms may be accompanied by nonmotor symptoms such as cognitive impairment. Many molecular processes may underlie the phenotypic heterogeneity of PD, among which synaptic and axonal degeneration, neuroinflammation, and the co-occurrence of different proteinopathies. The definition of robust biomarkers that reflect distinct pathophysiological pathways taking place in PD may favor the selection of more homogeneous cohorts of patients in clinical trials, thus increasing the chance of success of a targeted disease-modifying therapy. The possibility of measuring these markers in biological matrices suitable for repeated sampling could provide objective measures of the effectiveness of a therapeutic approach. In this proposal we will combine the expertise of three different Italian medical research centers to establish a molecular profile of PD based on biomarkers reflecting different biological pathways, in different biological matrices, by applying immunoassays, proximity extension assays (PEA) and seed amplification assays (SAA). Two easily accessible biological matrices, i.e., blood plasma and olfactory mucosa (OM), has been/will be collected in each center for PD patients, controls and patients affected by Alzheimer's disease (AD) as other neurodegenerative disease controls. OM will be collected by a non-invasive procedure known as nasal brushing which is already operational and standardized among the three participating centers. The project will include both a prospective and retrospective cohort composed of 200 PD patients, 100 controls and 40 AD. All PD patients that will be recruited will undergo a thorough clinical and neuropsychological evaluation. The control group will be constituted by healthy volunteers as well as by cognitively unimpaired subjects with subjective memory complaints or patients affected by minor neurological symptoms (i.e., headache, peripheral neuropathy, etc.). The above-mentioned clinical information has been already collected for the retrospective cohort. Plasma amyloid-ß (Aß) 42/Aß40 ratio and phosphorylated at threonine 181 tau (p-tau) will be measured with the Lumipulse automated platform for all collected plasma samples. In a subset of 80 PD patients and 40 AD the CSF levels of this markers have been already measured and will be used to assess the robustness of these markers as well as the correlation between their CSF and plasma levels. SAA will be applied in OM for the detection of misfolded a-synuclein. Phosphorylated a-synuclein (p-a-syn) will be measured in a subset of PD patients and controls to compare the diagnostic accuracy of p-a-syn in skin biopsies and a-synuclein seeding activity in OM. In a subset of 30 PD and 30 AD/CTRL with paired OM and CSF samples the CSF SAA protocol of Amprion Inc. will be applied to verify the concordance of the results between CSF and OM. CNBP will be specifically responsible for collecting clinical and biomarker data from the three centers and for assessing their relationships. For the sake of measurements uniformity, the PEA analyses will be instead centralized at Olink (Uppsala, Sweden), at which the Olink Explore 384 Inflammation and Olink Explore 384 Neurology panels will be measured in all plasma samples.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 340 (actual)
- First submitted
- 2 Mar 2026
- Start date
- May 2023
- Primary completion date
- Feb 2025
- Lead sponsor
- Azienda Ospedaliera di Perugia
- Diseases
- Alzheimer disease, Parkinson disease
- NCT number
- NCT07480187
What you commit to
- Study type: Interventional
- Participants enrolled: 340
- From May 2023 to the primary completion date, Feb 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior lumbar surgery complicating access
Other illness
- 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
- 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
- Local skin infection at biopsy site
- Severe dermatologic disease at sampling area
- Known bleeding disorder
- Allergy to local anesthetics
- Severe peripheral vascular disease
- MRI-conditional device not meeting safety conditions
- Severe motion disorder affecting acquisition
- Local infection at puncture site
- High bleeding risk due to anticoagulation
- History of severe vasovagal syncope during venipuncture
- Local infection at puncture site
- Recent epistaxis or bleeding-prone nasal mucosa
- 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
Other
- Eligibility Criteria
- Procedure-specific exclusion criteria
- Skin biopsy:
- Significant thrombocytopenia
- Anticoagulation not safely manageable
- Poor wound healing
- 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
- Pregnancy according to institutional MRI safety policy
- Severe agitation or confusion preventing examination
- Body size exceeding scanner limits
- Venipuncture:
- Refusal or inability to provide consent
- Severe coagulopathy
- Marked thrombocytopenia
- Severe anemia relative to planned blood draw volume
- Difficult venous access
- Lumbar puncture:
- Signs of increased intracranial pressure due to mass lesion
- Uncorrected coagulopathy
- Severe thrombocytopenia
- Anticoagulation not safely interruptible
- Spinal cord compression
- Unstable spine
- Refusal or inability to cooperate with the procedure
- Severe spinal deformity
- 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
- Nasal lesions, ulcers, or tumors
Who the study is looking for
- patients with clinical diagnosis of Parkinson's disease, atypical parkinsonisms, Alzheimer's disease, healthy volunteers, people with subjective cognitive decline.
- 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
Age in the registry: 30 years to - · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro Neurolesi Bonino Pulejo Coordinator of this site? Confirm its status | Messina | Italy | Unknown status |
| Istituto Neurologico Carlo Besta Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Azienda Ospedaliera di Perugia Coordinator of this site? Confirm its status | Perugia | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.