Using Artificial Intelligence to Detect Early Signs of Alzheimer's Disease in People With Memory Concerns

Sponsor
IRCCS San Raffaele
Study ID
NCT07652931
Status
Not Yet Recruiting

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Conditions

  • Alzheimer Disease
  • Cognitive Decline
  • Mild Cognitive Impairment
  • Subjective Cognitive Decline

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • High-frequency Transcranial Magnetic Stimulation (TMS) — DEVICE
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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 — OTHER
    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.

Study Details

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.

Key Dates

First listed
Jun 17, 2026
Start date
Aug 1, 2026
Status verified
Jun 2026
Primary completion
Aug 1, 2028
Completion
Aug 1, 2029

Study Design

Enrollment
300 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: SCD Participants
    All 300 SCD participants undergo baseline multimodal assessment. Those found to be AD plasma biomarker positive (SCD+) undergo longitudinal follow-up at M12 and M24. Those classified as high risk (plasma p-tau217 greater than 0.1325 pg/mL, and/or APOE epsilon4 carrier, and/or elevated CAIDE Dementia Risk Score) additionally receive a 6-month multidisciplinary personalized intervention combining high-frequency TMS, digital cognitive training, structured physical exercise, and targeted vascular and behavioral risk factor management.

Primary Outcome Measure

Diagnostic accuracy of AI models in identifying AD biomarker-positive SCD subjects (AUC) [ Time Frame: Baseline (study entry) ]

Central Contacts

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