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ALN-961583

Clinical trials are investigating ALN-961583 in people with cerebral amyloid angiopathy, a brain blood vessel condition linked to bleeding. These studies aim to evaluate efficacy, safety, and tolerability in adults with this condition.

Table of Contents

Trial overview

The available trial for ALN-961583 is an interventional study, which means researchers give a study treatment and compare the results with another group.[1] It is listed as Phase 2, a stage that is used to learn more about whether a treatment may work and how safe it is in the target group.[1] The trial status is Authorised, and the planned enrollment is 200 patients.[1]

Condition studied: cerebral amyloid angiopathy

The study focuses on cerebral amyloid angiopathy (CAA), a neurological condition in which amyloid proteins build up in the walls of blood vessels in the brain.[1] This buildup can cause problems such as bleeding into the brain.[1]

The trial description also refers to CAA as a condition linked to lobar cerebral microbleeds, which are small bleeding spots in the outer parts of the brain.[1] The study is especially interested in patients with symptomatic CAA, written in the source as sCAA.[1]

Study design and treatment groups

The trial compares ALN-961583 with placebo, which is a look-alike treatment with no active medicine.[1] The intervention list in the source names Mivelsiran and placebo, with Mivelsiran given by intrathecal use, meaning it is delivered into the fluid around the spinal cord.[1]

The brief summary says the study is designed to evaluate the effect of ALN-APP on the incidence of new lobar cerebral microbleeds.[1] In patient-friendly terms, the researchers want to see whether the study treatment changes how often new small bleeding spots appear on brain scans.[1]

Who can participate

The target population is patients with cerebral amyloid angiopathy.[1] The source does not provide more detailed eligibility rules, such as age limits or other medical requirements.[1]

Because this is a study in people with CAA, participation is aimed at adults who already have this condition or are being evaluated for it, based on the trial setting described in the source.[1]

What the trial measures

The primary outcome is the annualized rate of new lobar cerebral microbleeds detected by MRI in patients with CAA.[1] A primary outcome is the main result the study is built to measure.[1]

MRI stands for magnetic resonance imaging, a scan that makes detailed pictures of the brain.[1] In this trial, MRI is used to count new microbleeds over time, which helps researchers track whether the study treatment changes brain bleeding activity.[1]

Why this trial matters

This study is important because CAA can be linked to brain bleeding, and new microbleeds are one sign of ongoing disease activity.[1] By measuring both safety and the rate of new microbleeds, the trial aims to give a clearer picture of whether ALN-961583 may be useful for this condition.[1]

The trial is still in a mid-stage testing phase, so it is focused on learning more rather than proving final effectiveness.[1] The results may help guide later research in people with CAA.[1]

Trial ID Phase Condition studied Status Enrollment
2023-510137-29-01 Phase 2 Cerebral Amyloid Angiopathy (CAA) Authorised 200

FAQ

  • What is being studied in ALN-961583 clinical trials? The trials are studying whether ALN-961583 can affect the rate of new lobar cerebral microbleeds seen on MRI. They also look at safety and tolerability.
  • Who may take part in these trials? The target population is patients with cerebral amyloid angiopathy, also called CAA. The trial data does not give more detailed entry rules.
  • What phase is the ALN-961583 trial? The trial is in Phase 2. This means it is designed to learn more about how well the study treatment works and how safe it is in a patient group.
  • What condition is the trial focused on? The trial focuses on cerebral amyloid angiopathy, a neurological condition where amyloid proteins build up in brain blood vessel walls. This can lead to problems such as bleeding into the brain.
  • What is the main result the trial measures? The main endpoint is the annualized rate of new lobar cerebral microbleeds found by MRI. This helps researchers see whether the study treatment changes the number of new small bleeding spots in the brain.

Ongoing Clinical Trials on ALN-961583

  • Study on the Safety and Effects of ALN-APP for Patients with Cerebral Amyloid Angiopathy

    Not recruiting

    2 1
    Investigated drugs:
    The Netherlands

Glossary

  • Cerebral amyloid angiopathy (CAA): A brain blood vessel condition where amyloid proteins build up in vessel walls. This can raise the risk of bleeding in the brain.
  • Amyloid proteins: Proteins that can build up in the walls of blood vessels in the brain in CAA.
  • Cerebral microbleeds: Very small areas of bleeding in the brain that can be seen on MRI.
  • Lobar: A term that refers to the outer parts or lobes of the brain.
  • MRI: Magnetic resonance imaging, a scan that creates detailed pictures of the brain.
  • Primary outcome: The main result a clinical trial is designed to measure.
  • Phase 2: A mid-stage clinical trial that looks more closely at whether a treatment works and how safe it is.
  • Interventional study: A study in which researchers give a treatment or placebo and then compare results.
  • Placebo: A treatment that looks like the study drug but has no active medicine.
  • Tolerability: How well people can take a treatment without major problems.

References

  1. https://clinicaltrials.gov/study/2023-510137-29-01