NCT07402161 The Signature of Alzheimer's Disease in Subjective Cognitive Decline
| NCT ID | NCT07402161 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Policlinico S. Donato |
| Condition | Subjective Cognitive Decline (SCD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2027-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2025-10-01 with a primary completion date of 2027-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study focuses on improving early detection of Alzheimer's disease (AD) in patients with subjective cognitive decline (SCD), a preclinical stage of cognitive impairment, in the context of emerging disease-modifying therapies (DMTs). Current biomarkers, such as brain MRI, PET scans, and cerebrospinal fluid (CSF) markers, are highly accurate but costly, invasive, and not widely accessible. The study aims to provide cost-effective, scalable tools for early identification of individuals at risk, enabling personalized assessment and timely DMT administration. Objectives: * Evaluate the accuracy of innovative, easily accessible biomarkers in predicting biologically confirmed AD. * Assess the predictive utility of previously studied methods for SCD patients. * Explore new approaches, including automated speech analysis, to identify cognitive decline. * Evaluate genetic contributions to AD risk. * Integrate data from these various modalities using machine learning to create a predictive model for AD in SCD patients. Study Design: This is a multicenter, longitudinal, low-intervention study conducted at IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy (UO1) and the Center for Research and Innovation in Dementia, Careggi Hospital, Florence, Italy (UO2). Eligible participants are adults with SCD, intact daily functioning, and Mini-Mental State Examination (MMSE) scores \>24. Exclusion criteria include neurological or systemic diseases, major psychiatric disorders, substance use, or prior head injury. Participants undergo: * Detailed medical and family history collection. * Comprehensive neuropsychological, personality, and independence in daily activities assessment * EEG recording in resting state. * Blood sampling for plasma biomarkers (Aβ42, Aβ40, p-tau181, p-tau217, t-tau, NfL, GFAP). * CSF biomarker analysis (Aβ42, Aβ40, p-tau, t-tau). * Genetic analysis of AD-related genes (PSEN1, PSEN2, APOE, TREM2, ABCA7, BDNF, HTT). * Speech recording and analysis using standardized tasks to extract features for automated evaluation. The study expects to create a machine learning-based predictive model combining biomarker, neuropsychological, EEG, speech, and genetic data to improve early detection and guide personalized patient care. Procedures: * Neuropsychological evaluations occur at baseline and two-year follow-up. * Language recordings are conducted in controlled settings using standardized picture description tasks. * EEG is recorded using 21-channel systems. * Blood and CSF samples are collected, processed, and stored at -80°C for subsequent analysis at respective institutional laboratories. * Plasma biomarkers are analyzed with Simoa technology; CSF biomarkers are analyzed using chemiluminescent enzyme immunoassay (CLEIA). * Genetic analyses employ PCR, high-resolution melting analysis (HRMA), sequencing, and capillary electrophoresis as appropriate for specific genes or polymorphisms. The study expects to create a machine learning-based predictive model combining biomarker, neuropsychological, EEG, speech, and genetic data to improve early detection and guide personalized patient care.
Eligibility Criteria
Inclusion Criteria: * Clinical diagnosis of SCD according to the SCD-I criteria; * Mini-Mental State Examination (MMSE) score greater than 24, adjusted for age and education level; * Normal functioning on the Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) scales. Exclusion Criteria: * History of head trauma; * Current neurological and/or systemic diseases; * Symptoms of psychosis, major depression, or substance use disorder.
Contact & Investigator
Salvatore Mazzeo, MD, PhD
PRINCIPAL INVESTIGATOR
Università Vita-Salute San Raffaele, Milano - Neurology Unit, IRCCS Policlinico San Donato, San Donato Milanese
Frequently Asked Questions
Who can join the NCT07402161 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Subjective Cognitive Decline (SCD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07402161 currently recruiting?
Yes, NCT07402161 is actively recruiting participants. Contact the research team at mattia.ricotti@grupposandonato.it for enrollment information.
Where is the NCT07402161 trial being conducted?
This trial is being conducted at San Donato Milanese, Italy.
Who is sponsoring the NCT07402161 clinical trial?
NCT07402161 is sponsored by IRCCS Policlinico S. Donato. The principal investigator is Salvatore Mazzeo, MD, PhD at Università Vita-Salute San Raffaele, Milano - Neurology Unit, IRCCS Policlinico San Donato, San Donato Milanese. The trial plans to enroll 250 participants.