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New study aims to replace costly PET scans with MRI and blood tests for Alzheimer's patients

NCT ID NCT07456462

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study will test whether advanced MRI scans and blood tests can predict how well Alzheimer's patients respond to antibody drugs like lecanemab and donanemab. Researchers aim to create personalized models that show when amyloid plaques have been cleared from the brain, potentially replacing expensive PET scans. Fifty participants with early Alzheimer's will be followed for 18 months to see if these non-invasive methods can guide treatment decisions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
monoclonal antibodies (lecanemab or donanemab)
What this could lead to
If successful, this could lead to a safer, cheaper way to monitor Alzheimer's treatment and decide when to stop medication, tailored to each patient.
What could go wrong
This is a small, early-stage study with only 50 participants, so results may not apply to everyone. The models are still being developed and may not accurately predict treatment response.

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 50 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

May 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

30 to 90 years

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: 1Participant is willing and able to give informed consent for participation in the study. 2\. Participant is eligible for anti-amyloid therapy (AAT), i.e.: * Participants aged 30-90. * Diagnosis of early symptomatic AD, including MCI or mild dementia \[2\]. * Global Clinical Dementia Rating (CDR) score of 0.5 or 1.0 * Confirmed amyloid pathology through CSF or PET imaging. 3. Participant is willing to start Anti-amyloid therapy as part of his/her clinical-practice- therapeutic plan. 4\. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional four weeks after the end of study. 5\. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner. Exclusion Criteria: * 1\. Contraindications to AAT, including: * Significant neurological diseases other than AD that could affect cognition or study participation (e.g., other dementias, serious brain infections, Parkinson's disease, multiple concussions, epilepsy with recurrent seizures). * Homozygous ApoE4 genotype. * Current use of anticoagulant therapy. * Vascular abnormalities: Presence of more than 4 microhemorrhages (defined as ≤10 mm in greatest diameter), a single macrohemorrhage \>10 mm, superficial siderosis, evidence of vasogenic edema, multiple lacunar infarcts, or stroke involving a major vascular territory. * Amyloid-Related Imaging Abnormalities (ARIA): Evidence of ARIA, including cerebral amyloid angiopathy-related inflammation (CAA-ri) or amyloid beta-related angiitis (ABRA). * Bleeding disorders: History of bleeding disorders not under adequate control, including a platelet count \<50,000 or international normalized ratio (INR) \>1.5 for participants not on anticoagulant therapy. * Being currently under treatment with another AAT other than lecanemab/donanemab (e.g. as part of a Clinical Trial). 2\. Current serious or unstable illnesses, including: * Cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic diseases. * Conditions that, in the clinician's opinion, could interfere with study analyses or with a life expectancy of less than 24 months. * History of cancer within the last 5 years, except for non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, non-progressive prostate cancer, or other cancers with low risk of recurrence. 3\. Inability to undergo MRI or PET imaging procedures (e.g. non-MRI safe pacemaker or devices, claustrophobia etc). 4\. Women of childbearing potential who are not using adequate contraception, as well as pregnant or breastfeeding women.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognitive Dysfunction

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

More trials for these conditions

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