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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on people who are at risk for or in the early stages of Alzheimer's Disease, a brain condition that affects memory and thinking abilities. The research will test a new medication called RO7269162, which is taken as oral capsules, comparing it with a placebo to understand how well it works and how safe it is. The study aims to examine how this medication affects various markers of brain health, particularly the buildup of amyloid, a protein associated with Alzheimer's Disease.

During the study, participants will receive either RO7269162 or placebo capsules to take daily for up to 72 weeks. To monitor brain changes, participants will undergo PET scans using special imaging substances called florbetaben or flutemetamol, which are given through slow injection into a vein. These substances help make brain amyloid visible during the scanning procedure.

Throughout the study, various health measurements will be taken to ensure participant safety and to understand how the medication affects the body. This includes monitoring vital signs, conducting medical tests, and collecting samples to measure the levels of different substances in the blood and spinal fluid that are related to Alzheimer's Disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your body mass index (BMI) will be checked to confirm it falls between 18 and 35

    A PET scan will be performed to measure brain amyloid levels

    Your cognitive status will be evaluated using the Clinical Dementia Rating scale

  2. Step 2

    Study medication assignment

    You will be randomly assigned to receive either RO7269162 or a placebo

    The medication will be in the form of hard capsules taken by mouth daily

    If you are currently taking Alzheimer's medications, you may continue them if the dose has been stable for at least 8 weeks

  3. Step 3

    Regular monitoring

    Your vital signs and heart activity (ECG) will be regularly checked

    Blood tests will be performed to monitor safety

    Brain scans will be conducted to measure changes in amyloid levels

    Samples of blood and spinal fluid will be collected to measure medication levels and proteins related to Alzheimer's disease

  4. Step 4

    Study partner involvement

    Your designated study partner will need to maintain regular contact with you (minimum twice weekly)

    They will provide information about your cognitive and functional abilities throughout the study

    Communication can be in person, by phone, video calls, or email

  5. Step 5

    Study duration

    The study will run from March 2024 to July 2027

    Regular visits will be scheduled throughout this period to monitor your progress and safety

Who can join the trial?

6 criteria

  • Your Body Mass Index (BMI) must be between 18 and 35 kg/m2 (BMI is a measure of body fat based on height and weight)
  • You must be either: - Cognitively unimpaired (having normal thinking and memory abilities), or - Diagnosed with Mild Cognitive Impairment (MCI) due to Alzheimer's Disease
  • Your Clinical Dementia Rating-Global Score (CDR-GS) must be 0 or 0.5 (this is a scale that measures cognitive and functional performance)
  • You must have a positive amyloid PET scan with a measurement of 24 CL units or higher (this is a brain imaging test that detects protein deposits associated with Alzheimer's Disease)
  • You must have a study partner who: - Maintains regular contact with you (at least twice weekly) - Can provide accurate information about your cognitive abilities - Is in good health - Speaks the language used at the study site - Can maintain participation throughout the study
  • If you are taking medications for Alzheimer's Disease symptoms, your dosage must have remained stable for at least 8 weeks before starting the study medication

Who cannot join the trial?

15 criteria

  • Age below 50 or above 80 years
  • Any significant medical condition that could interfere with the study procedures
  • History of brain hemorrhage (bleeding in the brain) or stroke
  • Current diagnosis of any psychiatric disorder except mild depression
  • Use of medications that could interact with the study drug
  • Participation in another clinical trial within the past 30 days
  • Presence of any medical devices that would prevent MRI scanning (magnetic resonance imaging)
  • History of alcohol or drug abuse within the past 2 years
  • Severe liver or kidney disease
  • Pregnancy, breastfeeding, or planning to become pregnant
  • Inability to comply with study procedures or follow-up visits
  • Known allergic reactions to similar medications
  • Uncontrolled hypertension (high blood pressure)
  • Significant heart disease or recent heart problems
  • Blood clotting disorders or use of blood thinners
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Investigated drugs

RO7269162 is an investigational medication being studied for people who are at risk for Alzheimer's disease or are in the early stages before symptoms become severe. It is taken by mouth once daily. The medication is being tested to see if it can affect the buildup of amyloid (a protein that accumulates in the brains of people with Alzheimer's disease) and other biological markers related to the disease. The medication is still in early stages of research, and its safety and effectiveness are being evaluated.

What is already known about the treatment

RO7269162 - An experimental oral medication being investigated in Phase IIa clinical trials for Alzheimer's Disease treatment, specifically targeting individuals at risk or in the prodromal stage of the condition. This investigational drug is administered daily in oral form and is being studied for its effects on brain amyloid accumulation, which is a key pathological feature in Alzheimer's Disease. The medication is currently undergoing evaluation for safety and tolerability in a randomized, double-blind, placebo-controlled study across multiple research centers, though its exact molecular mechanism of action is not publicly disclosed in the available trial data.

Investigated diseases

Alzheimer's Disease - A progressive brain disorder that gradually destroys memory and thinking skills. The disease begins with mild memory loss and can progress to loss of the ability to carry on a conversation and respond to the environment. It primarily affects the parts of the brain that control thought, memory, and language. The disease involves the buildup of abnormal protein deposits called amyloid plaques and tau tangles in the brain. These changes cause brain cells to stop functioning and eventually die. The disease usually starts after age 60, with symptoms developing slowly and becoming more severe over time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506183-13-00Protocol codeBP44745Estimated enrolment231 patientsSponsorF. Hoffmann-La Roche AG

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