Using Artificial Intelligence to Detect Early Signs of Alzheimer's Disease in People With Memory … (NCT07652931) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Using Artificial Intelligence to Detect Early Signs of Alzheimer's Disease in People With Memory Concerns
Italy300 participantsStarted 2026-08-01
Plain-language 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.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is using AI to detect early Alzheimer's biomarkers in people with memory concerns — do you think my current level of memory concern matches what they're calling 'Subjective Cognitive Decline,' and would I even be a candidate to discuss with the research team?
2Since this study is listed as 'not yet recruiting,' how long might it realistically be before it opens, and should we be looking at other options in the meantime rather than waiting?
3The trial is measuring how accurately an AI model can identify Alzheimer's-related biomarkers — but what would actually happen if the AI flagged me as positive? Would that lead to a diagnosis, additional testing, or a change in my care?
4This is listed as a Phase N/A study, which suggests it's more of a diagnostic or observational tool than a treatment trial — so what are the practical risks or downsides of participating, and could any findings affect my insurance or how I'm treated by other doctors?
5Are there standard diagnostic tests already available — like PET scans or spinal fluid tests — that could give us similar information about Alzheimer's biomarkers right now, and how does what this AI trial is trying to do compare to those existing options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic accuracy of AI models in identifying AD biomarker-positive SCD subjects (AUC)