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Using Artificial Intelligence to Detect Early Signs of Alzheimer's Disease in People With Memory Concerns
Sponsor: IRCCS San Raffaele
Summary
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.
Official title: AHEAD: AI-driven Brain Health for Early Alzheimer's Disease Detection in Individuals With Subjective Cognitive Decline
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2026-08-01
Completion Date
2029-08-01
Last Updated
2026-06-17
Healthy Volunteers
No
Interventions
High-frequency Transcranial Magnetic Stimulation (TMS)
High-frequency repetitive TMS (rTMS) delivered according to an intensive protocol during the first 4 weeks of the intervention period (2-3 sessions per week). Applied to brain regions associated with cognitive function to optimize brain health and reduce risk of cognitive decline. Administered by trained professionals following international safety guidelines (Rossi et al., 2009).
Digital Cognitive Training
Home-based cognitive training delivered via digital platform over 5 months: 2 sessions per week of 30 minutes each. Targets perceived cognitive deficits and related domains (memory, executive functions, attention, visuospatial abilities, language) with progressive adaptation to individual performance level. Compliance monitored via dedicated applications and/or activity diaries. Monthly remote meetings with neuropsychologists to monitor progress.
Structured Physical Exercise
Home-based structured physical exercise program over 5 months: 2 sessions per week of 30 minutes each. Activities include walking, cycling, and global resistance training. An in-person familiarization session is conducted before program start. Monthly remote meetings with physiotherapists to monitor progress and adapt the program. Compliance remotely monitored via dedicated applications and/or activity diaries.
Management of Modifiable Vascular and Behavioral Risk Factors
Personalized pharmacological and non-pharmacological interventions targeting modifiable vascular and behavioral risk factors including blood pressure, cholesterol, BMI, physical inactivity, dietary habits, sleep quality, and social isolation. Monthly remote follow-up visits over 6 months to monitor treatment adherence and optimize risk factor control.
Locations (1)
San Raffaele Neurology Unit
Milan, Milano, Italy