Using Artificial Intelligence to Detect Early Signs of Alzheimer's Disease in People With Memory Concerns
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorIRCCS San Raffaele
About this trial
AHEAD is a prospective, longitudinal, risk-stratified single-arm interventional study enrolling 300 patients with Subjective Cognitive Decline (SCD) at IRCCS San Raffaele Hospital, Milan, Italy.
The study uses artificial intelligence (AI) to integrate multimodal data - including MRI, EEG, Optical Coherence Tomography (OCT), neuropsychological assessments, and plasma biomarkers - to identify individuals with underlying Alzheimer's disease (AD) biology and predict cognitive progression.
Only participants found to be AD plasma biomarker positive (SCD+) undergo longitudinal follow-up at 12 and 24 months. Participants classified as high risk additionally receive a 6-month personalized multidisciplinary intervention combining high-frequency transcranial magnetic stimulation (TMS), digital cognitive training, structured physical exercise, and targeted management of modifiable vascular and behavioral risk factors.
Eligibility criteria
Qualifiers
Diagnosis of Subjective Cognitive Decline (SCD) according to international diagnostic criteria (Jessen et al., 2014).
Self-experienced persistent decline in cognitive capacity in comparison with a previously normal status and unrelated to an acute event.
Normal age-, gender-, and education-adjusted performance on standardized cognitive tests used to classify mild cognitive impairment (MCI) or prodromal AD.
Age greater than or equal to 40 years.
Disqualifiers
Presence of MCI, prodromal AD, or dementia.
Any major systemic, psychiatric, or neurological disturbance.
Medical conditions or substance abuse that could interfere with cognition.
Pacemaker and/or other implanted neurostimulation devices in the head/neck district.
Trial design
Treatments tested in this trial
- High-frequency Transcranial Magnetic Stimulation (TMS)
- Digital Cognitive Training
- Structured Physical Exercise
- Management of Modifiable Vascular and Behavioral Risk Factors
Treatment groups
300 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov