Using Artificial Intelligence to Detect Early Signs of Alzheimer's Disease in People With Memory Concerns
Key facts
- Where
- Milan, ItalySee the site
Where in Italy
- San Raffaele Neurology UnitMilan, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- IRCCS San Raffaele
- Trial code
- NCT07652931
- Record updated
- 10 November 2026
- Original description
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.Read full original descriptionShow less
AHEAD: AI-driven Brain Health for Early Alzheimer's Disease Detection in Individuals With Subjective Cognitive Decline
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.
Inclusion: 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; Native Italian Speaker; Stable pharmacological treatment for at least 4 weeks prior to enrollment; Provision of oral and written informed consent to study participation.
Exclusion: Presence of MCI, prodromal AD, or dementia; Any major systemic, psychiatric, or neurological disturbance; Medical conditions or substance abuse that could interfere with cognition; Brain damage at routine MRI, including extensive cerebrovascular disorders; Traumatic or surgical wounds that could determine a risk of infection at the site of non-invasive stimulation; Known history of epilepsy (due to small risk of seizure induction from rTMS in epileptic patients); Pacemaker and/or other implanted neurostimulation devices in the head/neck district; Contraindications to undergoing MRI examination; Scalp alterations that could determine the spread of excessive current from the device; Denial of oral and written informed consent to study participation.