RO7812653 for Alzheimer's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called RO7812653 to determine its safety and behavior in the body for individuals with early Alzheimer's disease. The trial includes two groups: one receives the treatment, while the other receives a placebo (a harmless pill resembling the treatment but without an active ingredient). It seeks participants with probable Alzheimer's dementia or mild cognitive impairment due to Alzheimer's. Participants must be able to complete study tasks independently or with assistance and must have maintained a stable dose of any Alzheimer's medications for at least eight weeks before joining. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
If you are taking medications for Alzheimer's symptoms, you need to be on a stable dose for at least 8 weeks before joining the study and continue with it during the trial. The protocol does not specify about other medications, so it's best to discuss with the study team.
Is there any evidence suggesting that RO7812653 is likely to be safe for humans?
Research has shown that RO7812653 remains in the early stages of human testing. Initial studies found that participants might experience side effects, ranging from mild issues like headaches or nausea to more serious conditions. In some cases, reports have even indicated life-threatening reactions.
As this marks one of the first instances of RO7812653 being tested in humans, the full safety profile is not yet known. Researchers will closely monitor participants to gather more information on how individuals tolerate the treatment and what side effects may occur.12345Why do researchers think this study treatment might be promising for Alzheimer's?
Most treatments for Alzheimer's disease, like donepezil and memantine, focus on managing symptoms and slowing progression but don't address the underlying cause. RO7812653 is unique because it targets a different mechanism, aiming to modify the disease itself. Researchers are excited about this treatment because it offers a new approach by potentially altering the disease course, rather than just alleviating symptoms, which could lead to more significant and lasting improvements for patients.
What evidence suggests that RO7812653 might be an effective treatment for Alzheimer's?
Research has shown that RO7812653 is under development to treat Alzheimer's disease, which leads to memory loss and cognitive issues. In this trial, participants will receive either RO7812653 or a placebo. Although human studies have provided limited information so far, RO7812653 targets the disease's root causes. The goal is to slow or halt the progression of symptoms. Similar treatments have shown promise in slowing the disease, but the specific effects of RO7812653 remain under investigation. Early research focuses on understanding the drug's metabolism and initial safety. Experts hope RO7812653 will achieve success comparable to other recent advances in Alzheimer's treatment.12567
Who Is on the Research Team?
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Are You a Good Fit for This Trial?
This trial is for people with early symptoms of Alzheimer's disease or mild cognitive impairment due to Alzheimer's. Participants must be able and willing to complete study tasks, have good enough vision and hearing (with aids if needed), speak the test language, and be on stable medication if already treated.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single ascending dose of RO7812653 or placebo
Follow-up
Participants are monitored for safety, tolerability, pharmacokinetics, and pharmacodynamics after treatment
What Are the Treatments Tested in This Trial?
Interventions
- RO7812653
Trial Overview
The study is testing a new drug called RO7812653 compared to a placebo in people with early symptomatic Alzheimer's. The main goal is to see how safe and tolerable the new drug is, as well as how it behaves in the body.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive a dose of RO7812653
Participants will receive a dose of placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University
Citations
NCT07234942 | A Study to Investigate the Safety, ...
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 in Participants With Early Symptomatic Alzheimer's Disease ...
Clinical trials of new drugs for Alzheimer disease - PMC - NIH
In the TRAILBLAZER-ALZ study, donanemab slowed disease progression by 32% at 18 months (p = 0.04 vs. placebo), thus demonstrating clinical efficacy [51].
First-in-human study of RO7812653
This study is testing a medicine called RO7812653. It is being developed to treat Alzheimer's disease (AD). RO7812653 is an experimental medicine. This means ...
4.
alzheimers.org.uk
alzheimers.org.uk/find-a-clinical-trial/study-ro7812653-early-symptomatic-alzheimers-diseaseStudy of RO7812653 for early symptomatic Alzheimer's ...
The aim of this study is to compare RO7812653 with a placebo (a dummy medicine) to see: How well RO7812653 works; How safe RO7812653 is in ...
Alzheimer's disease drug development pipeline: 2026
There are currently 158 drugs in 192 AD trials. Data are available in summary form on alzpipeline.com.
A Study to Investigate the Safety, Tolerability ...
This study aims to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics following administration of RO ...
7.
forpatients.roche.com
forpatients.roche.com/en/trials/neurodegenerative-disorder/ad/a-study-to-investigate-the-safety--tolerability--pharma-49470.htmlClinical trial for Alzheimer's Disease (AD)
This study aims to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics following administration of RO7812653
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