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Efficacy and Safety of RO7568282 in Adults with Early Symptomatic Alzheimer’s Disease

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What is this trial about?

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

The study looks at people with Early Symptomatic Alzheimer’s Disease and tests whether the oral capsule called RO7568282 can slow the worsening of memory and thinking compared with a placebo. The purpose is to determine if the drug can reduce the rate of clinical decline over a period of about 72 weeks.

Participants will take one capsule each day and will attend regular clinic visits where several assessments are performed. The main assessment is the Clinical Dementia Rating scale, which measures changes in thinking, behavior, and daily function; a higher score means more impairment. Additional tests include the ADAS-Cog-13, a set of questions that check memory and problem‑solving ability, and the ADCS-ADL, which looks at how well a person can manage everyday activities. Safety checks involve blood and urine tests, measurement of vital signs, a heart‑electrical test called an ECG, and a questionnaire called the C-SSRS that screens for thoughts of self‑harm. Blood samples are also taken to study the drug’s pharmacokinetics, meaning how the body absorbs and clears the medication.

The study lasts roughly 72 weeks, with participants continuing the daily capsule throughout. At each visit, researchers record any side effects, check lab results, and repeat the cognitive and functional tests to track any changes over time.

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

    Baseline Assessments

    After you join the study, you will undergo a series of baseline assessments to document your health status before receiving any medication.

    These assessments include the Clinical Dementia Rating Sum of Boxes (CDR‑SB), the Alzheimer’s Disease Assessment Scale‑Cognitive Subscale (ADAS‑Cog‑13), the Alzheimer’s Disease Cooperative Study‑Activities of Daily Living (ADCS‑ADL) total and instrumental scores, vital‑sign measurements, an electrocardiogram (ECG), blood and urine laboratory tests, and the Columbia‑Suicide Severity Rating Scale (C‑SSRS).

  2. Step 2

    Randomization and Medication Assignment

    You will be randomly assigned to receive either the study drug RO7568282 or a matching placebo.

    Both the active drug and the placebo are provided as hard oral capsules, and you will receive written instructions on how to take the capsules.

  3. Step 3

    Start of Study Medication

    You will begin taking the assigned capsule according to the schedule given by the study staff.

    The medication will be taken orally for a duration of up to 72 weeks, which is the period used to evaluate the primary efficacy outcome.

  4. Step 4

    Regular Study Visits and Safety Monitoring

    Throughout the 72‑week treatment period, you will attend scheduled study visits.

    At each visit, you will undergo repeat clinical assessments (including CDR‑SB, ADAS‑Cog‑13, and ADCS‑ADL), vital‑sign checks, ECG recordings, and laboratory tests of blood and urine.

    You will be asked to report any adverse events you experience, and the study team will evaluate the severity and possible relationship to the study medication.

    Blood samples may be collected to measure plasma concentrations of RO7568282 and its metabolites for pharmacokinetic analysis.

  5. Step 5

    Final Assessment at Week 72

    At the end of the 72‑week period, you will undergo a final set of assessments identical to those performed at baseline.

    These final measurements will be used to determine changes in cognitive and functional scores, safety parameters, and drug exposure over the course of the study.

Who can join the trial?

6 criteria

  • Have evidence of Alzheimer’s disease brain changes, shown by an amyloid PET scan (a special brain imaging test) or by testing the fluid around the brain and spine called cerebrospinal fluid (CSF).
  • Have mild cognitive impairment or mild dementia caused by Alzheimer’s disease (early‑stage memory and thinking problems).
  • Be able to swallow whole capsules (the medication is taken as a whole pill).
  • Have a body mass index (BMI) between 18 and 34 kg/m² measured at the screening visit (BMI is a calculation using height and weight to assess body size).
  • Have an appropriate study partner who can attend visits and provide information about daily functioning.
  • Be within the study’s required age range as defined by the trial.

Who cannot join the trial?

4 criteria

  • Having any other illness besides Alzheimer’s disease that could affect cognition (your thinking, memory, or ability to understand)
  • Having an unstable or serious heart (cardiovascular) disease in the past year, high blood pressure that is not controlled (called chronic uncontrolled hypertension), or important irregularities on an ECG test (a simple heart rhythm recording)
  • Having a past or current serious cerebrovascular disease (problems with the blood vessels in the brain, such as strokes)
  • Having significant brain problems seen on an MRI scan (a detailed picture of the brain that shows abnormal areas)
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Investigated drugs

RO7568282 is an experimental oral medication that comes in a hard capsule. It is being studied to see if it can slow the progression of early symptomatic Alzheimer’s disease. In the trial, participants take this capsule by mouth, and researchers will check how it affects memory and thinking abilities over about a year and a half. The study also looks at how safe the drug is and how it moves through the body (pharmacokinetics). This medication is the only active treatment being tested in the trial.

What is already known about the treatment

RO7568282 - RO7568282 is taken as a hard capsule that is swallowed by mouth. It is an experimental drug currently being studied in phase II trials and is not yet approved for any use. The medication is being tested for people with early symptomatic Alzheimer’s disease to try to slow the decline in thinking and daily abilities. It works by binding to specific proteins in the brain that are involved in the disease, helping to reduce harmful buildup and support normal cell function, and is classified as an investigational oral small‑molecule disease‑modifying agent.

Investigated diseases

Early symptomatic Alzheimer’s disease (AD) - Early symptomatic Alzheimer’s disease (AD) is a stage of Alzheimer’s disease where mild cognitive symptoms first become noticeable. Individuals may experience occasional memory lapses, difficulty finding words, and subtle changes in thinking. As the disease advances, these problems gradually worsen, affecting daily activities and the ability to manage finances or medication. Spatial orientation may become less reliable, leading to occasional disorientation. Over time, the decline in memory and executive function continues, requiring increasing support from caregivers.
Trial detailsLast updated 29 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-526158-14-00Protocol codeBP46554Estimated enrolment330 patientsSponsorF. Hoffmann-La Roche AG

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