NCT07652931Not yet recruiting
Using Artificial Intelligence to Detect Early Signs of Alzheimer's Disease in People With Memory Concerns
AHEAD: AI-driven Brain Health for Early Alzheimer's Disease Detection in Individuals With Subjective Cognitive Decline
Source: ClinicalTrials.gov · Last updated 17 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 8 Jun 2026
- Start date
- 1 Aug 2026
- Primary completion date
- 1 Aug 2028
- Lead sponsor
- IRCCS San Raffaele
- Diseases
- Alzheimer disease
- NCT number
- NCT07652931
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 1 Aug 2026 to the primary completion date, 1 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| San Raffaele Neurology Unit Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.