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RO7486967 for Early Parkinson's Disease

Phase 1
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 15, and day 28
Awards & highlights

Study Summary

This trial will test the safety and effectiveness of a new drug for early Parkinson's Disease.

Who is the study for?
This trial is for early-stage Parkinson's Disease patients, within 5 years of diagnosis and at a disease stage ≤2.5. Participants can be treatment-naïve or on stable PD therapy. They must have completed COVID-19 vaccination, have specific genotypes related to TSPO, and not expect changes in their PD therapy during the study.Check my eligibility
What is being tested?
The trial tests RO7486967 against a placebo in people with early idiopathic Parkinson's Disease. It's randomized and double-blind, meaning neither participants nor researchers know who gets the real drug versus placebo until after results are collected.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones may include reactions at the injection site, flu-like symptoms, headache, dizziness or gastrointestinal issues due to its pharmacological action.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 15, and day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 15, and day 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants with adverse events (AEs)
The change in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores from baseline
Secondary outcome measures
Area under the curve (AUC) RO7486967 in Plasma
Change from baseline in parametric bindings of [18F]-DPA-714 in different brain areas at Day 25 PET
Maximum concentration (Cmax) of RO7486967 in Plasma
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RO7486967 ArmExperimental Treatment1 Intervention
Participants will receive RO07486967 for approximately 28 days with 14 days of follow up after the last dose.
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,432 Previous Clinical Trials
1,090,089 Total Patients Enrolled

Media Library

Placebo (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05924243 — Phase 1
Parkinson's Disease Research Study Groups: Placebo, RO7486967 Arm
Parkinson's Disease Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05924243 — Phase 1
Placebo (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05924243 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current scope of involvement in this experiment?

"The pharmaceutical giant Hoffmann-La Roche is responsible for the recruitment of 72 eligible patients to take part in this clinical trial. Recruitment will be done across two sites, Cedars Sinai Medical Center (Los Angeles, California) and Georgetown University (Washington D.C.)."

Answered by AI

Is this inquiry being implemented at multiple sites within our state?

"Patients can be enrolled in this trial at Cedars Sinai Medical Center in Los Angeles, California, Georgetown University in Washington D.C., and NeuroStudies.net LLC in Decatur, Georgia as well as 13 other sites across the nation."

Answered by AI

Is it possible to participate in this research endeavor?

"To be eligible for this parkinson's disease clinical trial, potential participants must fall between the age range of 40 and 85. This medical study is currently recruiting 72 patients in total."

Answered by AI

Is the recruitment of participants still ongoing for this experiment?

"Clinicaltrials.gov records indicate that this medical trial is open for recruitment, having been posted on September 22nd 2022 and most recently updated June 21st 2023."

Answered by AI

Has the FDA given clearance to RO7486967 Arm?

"As this is a Phase 1 trial and there are limited data supporting RO7486967's efficacy and safety, it has been assigned a score of 1."

Answered by AI

Are individuals who are over 30 years old eligible to participate in this experiment?

"This research is seeking out individuals aged between 40 and 85 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Investigate The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7486967 in Participants With Early Idiopathic Parkinson's Disease
2022. "A Study to Investigate The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7486967 in Participants With Early Idiopathic Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05924243.
~23 spots leftby Jan 2025
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