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ALN-961583

Clinical trials investigating ALN-961583 are studying its use in people with cerebral amyloid angiopathy (CAA), a brain blood vessel condition linked to bleeding. The trials aim to evaluate efficacy, safety, and tolerability in adult patients, with MRI-based measures used to assess outcomes.

Table of contents

Trial overview

The available trial for ALN-961583 is titled “A Study to Evaluate the Efficacy, Safety and Tolerability of ALN-APP in Patients with Cerebral Amyloid Angiopathy (CAA).”[1] It is an interventional study, which means researchers give a treatment and then measure what happens.[1] The study is listed as Phase 2 and is Authorised.[1]

Condition being studied

The trial is in people with cerebral amyloid angiopathy (CAA).[1] CAA is described in the source as a neurological condition where amyloid proteins build up in the walls of blood vessels in the brain, which can lead to problems such as bleeding into the brain.[1]

The study also focuses on new lobar cerebral microbleeds, which are small areas of bleeding seen in brain scans.[1] “Lobar” refers to a specific brain region, so the trial is looking at microbleeds in those areas.[1]

Study design and treatment groups

The trial includes ALN-961583, listed in the source as Mivelsiran, and a placebo group.[1] A placebo is an inactive treatment used for comparison, so researchers can better judge whether the study treatment makes a difference.[1] The intervention is given by intrathecal use, which means it is administered into the fluid around the spinal cord.[1]

Who can participate

The source data says the trial is for patients with cerebral amyloid angiopathy.[1] No more detailed eligibility rules are provided in the trial data, so the exact age limits or other entry criteria are not available here.[1]

What the trial measures

The main outcome is the annualized rate of new lobar cerebral microbleeds seen on MRI in patients with CAA.[1] “Annualized rate” means how often the event happens over one year.[1] MRI, or magnetic resonance imaging, is a scan that gives detailed pictures of the brain.[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] The trial title also states that efficacy, safety, and tolerability are being evaluated.[1]

Current status and size

The trial is listed as Authorised, so it has been approved to proceed according to the source record.[1] The planned enrollment is 200 participants.[1] This makes it a moderate-sized Phase 2 study focused on learning more about the treatment in patients 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 the ALN-961583 trial? The trial is studying whether ALN-961583 can help reduce new lobar cerebral microbleeds in people with cerebral amyloid angiopathy. It also looks at safety and tolerability.
  • Who can take part in the trial? The trial is for patients with cerebral amyloid angiopathy. The source data does not list more detailed entry rules.
  • What phase is the ALN-961583 trial? The study is a Phase 2 trial. This means it is testing the treatment in patients to learn more about how well it works and how safe it is.
  • What outcome is the trial measuring? The main outcome is the annualized rate of new lobar cerebral microbleeds seen on MRI. This helps researchers track changes in the brain over time.
  • Is the trial using a comparison group? Yes. The study includes ALN-961583 and placebo. A placebo is an inactive treatment used for comparison.

Sperimentazioni cliniche in corso su ALN-961583

  • Studio sulla sicurezza e tollerabilità di ALN-APP in pazienti con angiopatia amiloide cerebrale

    In arruolamento

    1
    Malattie in studio:
    Farmaci in studio:
    Paesi Bassi

Glossario

  • Cerebral amyloid angiopathy (CAA): A condition where amyloid proteins build up in the walls of blood vessels in the brain. This can increase the risk of bleeding in the brain.
  • Amyloid: A protein that can build up in tissues. In this trial, it is described as building up in brain blood vessel walls.
  • Lobar: A word that refers to a specific area of the brain. In this study, it describes microbleeds found in certain brain regions.
  • Cerebral microbleeds: Small areas of bleeding in the brain that can be seen on MRI scans.
  • MRI: Magnetic resonance imaging, a scan that creates detailed pictures of the brain.
  • Annualized rate: A way to measure how often something happens over one year.
  • Safety: How well a treatment can be used without causing unacceptable problems.
  • Tolerability: How well patients can handle a treatment.
  • Efficacy: How well a treatment works for the condition being studied.
  • Placebo: An inactive treatment used for comparison in a clinical trial.
  • Interventional study: A study in which researchers give a treatment and then measure its effects.

Riferimenti

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