Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07467460
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07467460
Study Brief:
Protocol Section:
NCT07467460