AI could spot Alzheimer's years before symptoms worsen
NCT ID NCT07652931
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
The AHEAD study is testing whether artificial intelligence can help detect early signs of Alzheimer's disease in people who feel their memory is slipping but still test normal. Researchers will use brain scans, eye tests, and blood markers to identify those at highest risk. High-risk participants will receive a 6-month program including brain stimulation, cognitive training, and exercise to potentially slow decline.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- High-frequency Transcranial Magnetic Stimulation (TMS) and digital cognitive training
- What this could lead to
- If successful, this could lead to a way to identify people at high risk for Alzheimer's early and offer a personalized treatment plan to slow cognitive decline.
- What could go wrong
- This is an early, single-arm study without a control group, so results may not be definitive. The AI models may not be accurate enough, and the intervention's benefits are uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Diagnosis of Subjective Cognitive Decline (SCD) according to international diagnostic criteria (Jessen et al., 2014). 2. Self-experienced persistent decline in cognitive capacity in comparison with a previously normal status and unrelated to an acute event. 3. Normal age-, gender-, and education-adjusted performance on standardized cognitive tests used to classify mild cognitive impairment (MCI) or prodromal AD. 4. Age greater than or equal to 40 years. 5. Native Italian Speaker. 6. Stable pharmacological treatment for at least 4 weeks prior to enrollment. 7. Provision of oral and written informed consent to study participation. Exclusion Criteria: 1. Presence of MCI, prodromal AD, or dementia. 2. Any major systemic, psychiatric, or neurological disturbance. 3. Medical conditions or substance abuse that could interfere with cognition. 4. Pacemaker and/or other implanted neurostimulation devices in the head/neck district. 5. Contraindications to undergoing MRI examination. 6. Brain damage at routine MRI, including extensive cerebrovascular disorders. 7. Traumatic or surgical wounds that could determine a risk of infection at the site of non-invasive stimulation. 8. Scalp alterations that could determine the spread of excessive current from the device. 9. Known history of epilepsy (due to small risk of seizure induction from rTMS in epileptic patients). 10. Denial of oral and written informed consent to study participation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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San Raffaele Neurology Unit
Milan, Milano, 20132, Italy
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