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Simple blood test may replace spinal taps for Alzheimer's diagnosis

NCT ID NCT07717567

Knowledge-focused Sponsor: IRCCS San Raffaele Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This study is testing whether proteins in the blood can accurately diagnose Alzheimer's disease and predict how quickly it will progress. Researchers will follow 2,000 adults with memory complaints for five years, collecting annual blood samples. The goal is to find a less invasive and cheaper alternative to current diagnostic methods like spinal taps and brain scans.

What this could mean

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

What this could lead to
If successful, this could lead to a simple blood test to diagnose Alzheimer's disease and predict its progression, replacing more invasive procedures.
What could go wrong
This is an observational study, not a treatment trial. The biomarkers may not prove accurate enough for widespread clinical use.

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.

Participants

About 2,000 people

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

Started

Sep 2023

Expected to finish

Jun 2032

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.

Who is studied

Adult patients attending the Cognitive Disorders and Dementia Center (CDCD) at IRCCS San Raffaele Hospital, Milan, Italy, presenting with subjective or objective cognitive complaints of progressive and suspected neurodegenerative nature.

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 (main study and sub-study): 1. Age greater than or equal to 40 years (patients of childbearing age are admitted). 2. Subjective or objective cognitive complaints, progressive in nature and of suspected neurodegenerative origin. 3. Mini-Mental State Examination (MMSE) score greater than or equal to 18. Additional inclusion criterion for the validation sub-study: 4. Availability of CSF biomarkers for Alzheimer's disease within 6 months of the blood draw. Exclusion Criteria (main study): 1. Secondary forms of cognitive impairment based on medical history, neurological examination, and neuroimaging findings. 2. Pregnancy or breastfeeding. 3. Rapidly progressive cognitive decline occurring over weeks or months, typically indicative of prion disease, neoplasia, or metabolic disorders. 4. Subjects who require a legal guardian or tutor. Exclusion Criteria (validation sub-study): 1. Secondary forms of cognitive impairment based on medical history, neurological examination, and neuroimaging findings. 2. Pregnancy. 3. Rapidly progressive cognitive decline occurring over weeks or months, typically indicative of prion disease, neoplasia, or metabolic disorders. 4. Subjects who are unable to give informed consent and require a legal guardian or tutor.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognitive Dysfunction dementia subjective cognitive decline

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer disease Cognitive impairment Dementia Mild cognitive impairment Subjective cognitive decline

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

  • IRCCS Ospedale San Raffaele - Cognitive Disorders and Dementia Center (CDCD)

    RECRUITING

    Milan, Milano, 20132, Italy

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