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Ro7269162

Clinical trials are investigating Ro7269162 in people at risk for or already in the prodromal stage of Alzheimer’s disease. These studies look at safety, tolerability, and long-term biomarker changes, including brain amyloid measured by PET scans. The goal is to understand whether Ro7269162 can affect disease-related changes in this target population.

Table of Contents

Trial overview

The main study of Ro7269162 is an interventional Phase 2 trial in Alzheimer’s disease.[1] It is designed to evaluate safety and long-term biomarker effects in people at risk for or already in the prodromal stage of Alzheimer’s disease.[1]

The trial is authorised and plans to include 247 participants.[1] The study title shows that the researchers are especially interested in safety and changes in brain amyloid over time.[1]

Who can participate

This study targets people who are at risk for Alzheimer’s disease or who are in the prodromal stage of the disease.[1] The prodromal stage means very early disease changes, when symptoms may be mild or just starting.[1]

The trial data do not list detailed inclusion or exclusion rules, so the available information only shows the general target population.[1]

What is being measured

The primary outcomes include the nature, incidence, severity, and outcome of adverse events, which are unwanted medical problems that happen during a study.[1] The study also tracks changes from baseline in vital signs, ECG results, Columbia-Suicide Severity Rating Scale findings, and safety laboratory tests.[1]

Another main outcome is change from baseline in brain amyloid load, measured by an amyloid PET scan.[1] Amyloid is a protein that can build up in the brain in Alzheimer’s disease, and PET scans are imaging tests that help researchers measure it.[1]

Trial phase and status

The study is in Phase 2, which usually means researchers are looking more closely at safety and early signs of effect in a specific group of patients.[1] The trial status is listed as authorised.[1]

Because this is a Phase 2 study, the main focus is not final proof of benefit, but whether the study treatment can be studied safely and whether it changes disease-related markers.[1]

Study treatments and scans

The trial includes daily oral dosing of Ro7269162 and compares it with placebo Ro7269162 in parts of the study design.[1] The source also lists two imaging agents used for amyloid scans: FLUTEMETAMOL (18F) and FLORBETABEN (18F).[1]

These scan agents are used with PET imaging to help measure amyloid in the brain.[1] The study brief summary says the goal is to investigate the safety and tolerability of daily oral dosing of Ro7269162 and its effect on brain amyloid accumulation.[1]

Why this study matters

Alzheimer’s disease is a serious brain condition, and studies in early stages may help researchers learn whether treatment can change disease-related markers before symptoms become more advanced.[1] This trial is focused on early disease risk and prodromal disease, so it may help build evidence for future research in earlier Alzheimer’s care.[1]

Trial ID Phase Condition studied Status Enrollment
2023-506183-13-00 Phase 2 Alzheimer’s Disease Authorised 247

FAQ

  • What is being studied in Ro7269162 clinical trials? The trial is studying the safety and long-term biomarker effects of Ro7269162. It also looks at brain amyloid, which is a protein buildup linked to Alzheimer’s disease.
  • Who can join these trials? The study includes participants who are at risk for Alzheimer’s disease or who are in the prodromal stage of the disease. Prodromal means early symptoms or early disease changes before full illness is present.
  • What phase is the Ro7269162 study? This is a Phase 2 trial. Phase 2 studies usually look more closely at whether a treatment may help and how safe it is in a specific patient group.
  • What tests or measurements are used in the study? The trial measures adverse events, vital signs, ECG results, suicide risk screening, laboratory tests, and amyloid PET scans. These help researchers track safety and changes in the brain.
  • What condition is this trial focused on? The study focuses on Alzheimer’s disease. It is aimed at people who are at risk for the disease or already in the prodromal stage.

Ongoing Clinical Trials on Ro7269162

  • Study of RO7269162 in people at risk for or with early-stage Alzheimer’s Disease: Effects on brain amyloid buildup

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark France Germany Italy Poland Spain

Glossary

  • Alzheimer’s disease: A brain disease that slowly affects memory, thinking, and daily function.
  • Prodromal stage: An early stage of a disease when mild signs or symptoms may begin before the full disease is clear.
  • Phase 2: A trial stage that checks safety and early signs of benefit in a defined group of people.
  • Biomarker: A measurable sign in the body, such as a scan or lab result, that can show how a disease is changing.
  • Amyloid: A protein that can build up in the brain in Alzheimer’s disease.
  • PET scan: A type of brain scan that shows how certain substances are distributed in the body or brain.
  • Adverse events (AEs): Unwanted medical problems that happen during a study, whether or not they are caused by the study treatment.
  • Vital signs: Basic body measurements such as blood pressure, pulse, and temperature.
  • ECG: A test that records the electrical activity of the heart.
  • C-SSRS: A questionnaire used to check for suicidal thoughts or behavior.

References

  1. https://clinicaltrials.gov/study/2023-506183-13-00