RO7812653 for Alzheimer's Disease

Not currently recruiting at 12 trial locations
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Overseen ByFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Hoffmann-La Roche
Must be taking: Symptomatic AD medications

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.12345

Why 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?

CT

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

Fluency in the language of the tests used at the study site
Adequate visual and auditory acuity sufficient to perform neuropsychological testing (eyewear and hearing aids permitted)
Agreement not to participate in other research studies for the duration of this study
See 3 more

Exclusion Criteria

Any medical history or evidence of a condition other than AD that may affect cognition
Any other significant cerebral abnormalities considered clinically significant by Investigator
History of schizophrenia, schizoaffective disorder, major depression or bipolar disorder
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single ascending dose of RO7812653 or placebo

1 week

Follow-up

Participants are monitored for safety, tolerability, pharmacokinetics, and pharmacodynamics after treatment

40 weeks

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

Group I: RO7812653Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials
2,482
Recruited
1,107,000+
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Avastin, Herceptin, Rituxan, Accu-Chek
Dr. Levi Garraway profile image

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker profile image

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 ...

Study 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 ...

Clinical trial for Alzheimer's Disease (AD)

This study aims to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics following administration of RO7812653