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AI could spot Alzheimer's years before symptoms worsen

NCT ID NCT07652931

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

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

40 years and older

Sex

Anyone

Healthy volunteers

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

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.

Alzheimer disease Cognitive Dysfunction Motor Activity subjective cognitive decline

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • San Raffaele Neurology Unit

    Milan, Milano, 20132, Italy

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