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New drug aims to stop brain bleeds in rare disease

NCT ID NCT06393712

Disease control Sponsor: Alnylam Pharmaceuticals Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 18, 2026 · Updated 5 times

Summary

This study tests an experimental drug called ALN-APP in 200 adults with cerebral amyloid angiopathy (CAA), a condition that causes bleeding in the brain. The drug is given via spinal injection and aims to slow disease progression and reduce new brain bleeds. Participants will be followed for up to 50 months to check safety and effectiveness.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

210 people

The number who actually took part.

Started

May 2024

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 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 (sporadic CAA patients): * Is 50 years or older * Has probable CAA per the Boston Criteria Version 2.0 Inclusion Criteria (Dutch-type CAA patients): * Is 30 years or older * Has known E693Q amyloid precursor protein (APP) gene mutation for Dutch-type CAA Exclusion Criteria: * Moderate or severe stage Alzheimer's disease (AD) or significant cognitive impairment (CI) * Has a history of previous clinical intracerebral hemorrhage (ICH) with onset less than 90 days prior to anticipated randomization in the study * Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3×upper limit of normal (ULN) at Screening * Has estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m\^2 at Screening * Has recently received an investigational agent * Has had treatment with amyloid-targeting antibody Note: other protocol defined inclusion / exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

cerebral amyloid angiopathy

As listed by the trial registrant

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

Cerebral amyloid angiopathy

Contacts and locations

Locations

  • Clinical Trial Site

    Los Angeles, California, 90095, United States

  • Clinical Trial Site

    Orange, California, 92868, United States

  • Clinical Trial Site

    Palo Alto, California, 94304, United States

  • Clinical Trial Site

    Sacramento, California, 95816, United States

  • Clinical Trial Site

    San Francisco, California, 94114, United States

  • Clinical Trial Site

    Aurora, Colorado, 80045, United States

  • Clinical Trial Site

    New Haven, Connecticut, 06510, United States

  • Clinical Trial Site

    Gainesville, Florida, 32608, United States

  • Clinical Trial Site

    Jacksonville, Florida, 32224, United States

  • Clinical Trial Site

    Maitland, Florida, 32751, United States

  • Clinical Trial Site

    Naples, Florida, 34105, United States

  • Clinical Trial Site

    Chicago, Illinois, 60612, United States

  • Clinical Trial Site

    Lexington, Kentucky, 40504, United States

  • Clinical Trial Site

    New Orleans, Louisiana, 70121, United States

  • Clinical Trial Site

    Boston, Massachusetts, 02114, United States

  • Clinical Trial Site

    Plymouth, Massachusetts, 02360, United States

  • Clinical Trial Site

    Rochester, Minnesota, 55905, United States

  • Clinical Trial Site

    St Louis, Missouri, 63110, United States

  • Clinical Trial Site

    Hackensack, New Jersey, 07601, United States

  • Clinical Trial Site

    New York, New York, 10016, United States

  • Clinical Trial Site

    New York, New York, 10029, United States

  • Clinical Trial Site

    New York, New York, 10032, United States

  • Clinical Trial Site

    New York, New York, 10065, United States

  • Clinical Trial Site

    Durham, North Carolina, 27705, United States

  • Clinical Trial Site

    Canton, Ohio, 44718, United States

  • Clinical Trial Site

    Cleveland, Ohio, 44195, United States

  • Clinical Trial Site

    Abington, Pennsylvania, 19001, United States

  • Clinical Trial Site

    Philadelphia, Pennsylvania, 19104, United States

  • Clinical Trial Site

    Pittsburgh, Pennsylvania, 15213, United States

  • Clinical Trial Site

    Dallas, Texas, 75243, United States

  • Clinical Trial Site

    Dallas, Texas, 75390, United States

  • Clinical Trial Site

    Houston, Texas, 77030, United States

  • Clinical Trial Site

    San Antonio, Texas, 78229, United States

  • Clinical Trial Site

    Seattle, Washington, 98104, United States

  • Clinical Trial Site

    Adelaide, 5000, Australia

  • Clinical Trial Site

    Brisbane, 4029, Australia

  • Clinical Trial Site

    Heidelberg, 3084, Australia

  • Clinical Trial Site

    Nedlands, 6009, Australia

  • Clinical Trial Site

    Parkville, 3050, Australia

  • Clinical Trial Site

    Calgary, T2N 4Z6, Canada

  • Clinical Trial Site

    Hamilton, L8L 2X2, Canada

  • Clinical Trial Site

    Kelowna, V1Y 1Z9, Canada

  • Clinical Trial Site

    Moncton, E1C 2Z3, Canada

  • Clinical Trial Site

    Montreal, H3A 2B4, Canada

  • Clinical Trial Site

    Montreal, H3G 1H9, Canada

  • Clinical Trial Site

    Ottawa, K1Z 1G3, Canada

  • Clinical Trial Site

    Toronto, M3B 2S7, Canada

  • Clinical Trial Site

    Victoria, V8R 1J8, Canada

  • Clinical Trial Site

    Amsterdam, 1081 GN, Netherlands

  • Clinical Trial Site

    Leiden, 2333ZA, Netherlands

  • Clinical Trial Site

    Nijmegen, 6525 GA, Netherlands

  • Clinical Trial Site

    Bern, 3010, Switzerland

  • Clinical Trial Site

    Geneva, 1205, Switzerland

  • Clinical Trial Site

    Sankt Gallen, 9007, Switzerland

  • Clinical Trial Site

    Glasgow, G51 4TF, United Kingdom

  • Clinical Trial Site

    London, SE5 8AF, United Kingdom

  • Clinical Trial Site

    London, WC1N 3BG, United Kingdom

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Other studies related to the condition(s) this trial covers.