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Monoclonal Antibodies

RO7126209 for Alzheimer's Disease

Phase 1 & 2
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
Probable mild to moderate Alzheimer's Disease (AD) dementia (consistent with National Institute on Aging-Alzheimer's Association [NIA-AA] core clinical criteria for probable AD dementia) or prodromal AD (consistent with the NIA-AA diagnostic criteria and guidelines for mild cognitive impairment due to AD)
Adequate visual and auditory acuity, sufficient to perform neuropsychological testing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part 1 and 2: up to approximately 56 weeks; part 3: up to approximately 52 weeks; part 4: up to approximately 129 weeks
Awards & highlights

Study Summary

This trial will study the safety and effectiveness of an experimental drug for Alzheimer's disease.

Who is the study for?
This trial is for people with early or moderate Alzheimer's who can perform tests with a study partner's help. They must have stable Alzheimer's medication use, good vision and hearing for testing, an MMSE score of 18-28, and a positive amyloid PET scan. Those with other neurological conditions or significant medical issues, MRI contraindications, or hypersensitivity to biologic agents cannot join.Check my eligibility
What is being tested?
The trial is testing RO7126209 via IV against a placebo in those with mild to moderate Alzheimer's. It aims to assess the drug’s safety and effects on the body (pharmacokinetics) and its impact on the disease (pharmacodynamics), including how well it is tolerated by patients over multiple doses.See study design
What are the potential side effects?
Potential side effects are not specified but may include reactions related to IV infusion, immune responses due to biological nature of RO7126209, changes in brain imaging results from MRIs or PET scans used during the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with mild to moderate Alzheimer's or early-stage Alzheimer's.
Select...
I can see and hear well enough to take tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part 1 and 2: up to approximately 56 weeks; part 3: up to approximately 52 weeks; part 4: up to approximately 129 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and part 1 and 2: up to approximately 56 weeks; part 3: up to approximately 52 weeks; part 4: up to approximately 129 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1, 2, 3, and 4: Percentage of Participants With Adverse Events (AEs)
Part 3: Change From Baseline in Brain Amyloid Load as Measured by Amyloid Positron Emission Tomography (PET) Scan
Secondary outcome measures
Part 1, 2, 3, and 4: Cerebral Spinal Fluid (CSF) Concentration of RO7126209
Part 1, 2, 3, and 4: Number of Participants With Anti-Drug Antibodies (ADAs) to RO7126209
Part 1, 2, 3, and 4: Plasma Concentration of RO7126209
+1 more

Side effects data

From 2020 Phase 1 trial • 36 Patients • NCT04023994
75%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
RO7126209 (0.1 mg/kg)
RO7126209 (0.4 mg/kg)
RO7126209 (1.2 mg/kg)
RO7126209 (3.6 mg/kg)
RO7126209 (7.2 mg/kg)

Trial Design

21Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 4: Open Label Extension (OLE) phase Arm 1: RO7126209Experimental Treatment1 Intervention
Participants who completed Part 1, 2, or 3 and have reached amyloid negativity (≤ 24 centiloids) in either of the Study Parts or at the OLE baseline visit will receive RO7126209 Q12W for 101 weeks. The dose level will depend on the dose level in Part 1, 2, and 3.
Group II: Part 4 OLE Phase Arm 3: RO7126209Experimental Treatment1 Intervention
Participants who completed Part 1, 2, or 3 and who are amyloid positive (≥24 centiloids) at week 12 of OLE will receive RO7126209 Q4W for an additional 12 weeks, before to switch to Q12W dosing for the remaining 77 weeks in an open-label treatment period. The dose level will depend on the dose level received in Part 1,2, and 3.
Group III: Part 4 OLE Phase Arm 2: RO7126209Experimental Treatment1 Intervention
Participants who completed Part 1, 2, or 3 and who are amyloid positive (≥24 centiloids) will receive RO7126209 Q4W for 12 weeks and will have to reach amyloid negativity (≤ 24 centiloids) before they can switch to Q12W dosing in an open-label treatment period of 89 weeks. The dose level will depend on the dose level received in Part 1,2, and 3.
Group IV: Part 3 Dose/Frequency/PD Relationship: Dose Level 2: RO7126209Experimental Treatment1 Intervention
Participants will receive multiple doses of RO7126209 in an open-label treatment period at dose level 2, Q12W, for 24 weeks followed by a 28-week safety follow-up period.
Group V: Part 3 (Dose/Frequency/Pharmacodynamic (PD) Relationship): Dose Level 1: RO7126209Experimental Treatment1 Intervention
Participants will receive multiple doses of RO7126209 in an open-label treatment period at dose level 1, Q4W, for 24 weeks followed by a 28-week safety follow-up period.
Group VI: Part 2 (Expansion) Cohort 3: Dose Level 3 of RO7126209Experimental Treatment1 Intervention
Participants will receive a total of 2 doses of RO7126209 at dose level 3, Q4W, for 28 weeks followed by an 8-week safety follow-up period.
Group VII: Part 2 (Expansion) Cohort 2: Dose Level 2 of RO7126209Experimental Treatment1 Intervention
Participants will receive multiple doses of RO7126209 at dose level 2, Q4W, for 28 weeks followed by a 28-week safety follow-up period.
Group VIII: Part 2 (Expansion) Cohort 1: Dose Level 1 of RO7126209Experimental Treatment1 Intervention
Participants will receive multiple doses of RO7126209 at dose level 1, Q4W, for 28 weeks followed by a 28-week safety follow-up period.
Group IX: Part 1 (Dose Finding) Cohort 5: Dose Level 5 of RO7126209Experimental Treatment1 Intervention
Participants will receive a total of 2 doses of RO7126209 at dose level 5 Q4W, for 28 weeks followed by an 8-week safety follow-up period.
Group X: Part 1 (Dose Finding) Cohort 4: Dose Level 4 of RO7126209Experimental Treatment1 Intervention
Participants will receive multiple doses of RO7126209 at dose level 4, Q4W, for 28 weeks followed by a 28-week safety follow-up period.
Group XI: Part 1 (Dose Finding) Cohort 3: Dose Level 3 of RO7126209Experimental Treatment1 Intervention
Participants will receive multiple doses of RO7126209 at dose level 3, Q4W, for 28 weeks followed by a 28-week safety follow-up period.
Group XII: Part 1 (Dose Finding) Cohort 2: Dose Level 2 of RO7126209Experimental Treatment1 Intervention
Participants will receive multiple doses of RO7126209 at dose level 2, Q4W, for 28 weeks followed by a 28-week safety follow-up period.
Group XIII: Part 1 (Dose Finding) Cohort 1: Dose Level 1 of RO7126209Experimental Treatment1 Intervention
Participants will receive multiple doses of RO7126209 at dose level 1 once every 4 weeks (Q4W) for 28 weeks followed by a 28-week safety follow-up period.
Group XIV: Part 2 (Expansion) Cohort 3: PlaceboPlacebo Group1 Intervention
Participants will receive a total of 2 doses of matching placebo to dose level 3, Q4W, for 28 weeks followed by an 8-week safety follow-up period.
Group XV: Part 1 (Dose Finding) Cohort 5: PlaceboPlacebo Group1 Intervention
Participants will receive a total of 2 doses of matching placebo to dose level 5 Q4W, for 28 weeks followed by an 8-week safety follow-up period.
Group XVI: Part 2 (Expansion) Cohort 2: PlaceboPlacebo Group1 Intervention
Participants will receive matching placebo to dose level 2, Q4W, for 28 weeks followed by a 28-week safety follow-up period.
Group XVII: Part 1 (Dose Finding) Cohort 1: PlaceboPlacebo Group1 Intervention
Participants will receive matching placebo to dose level 1 Q4W for 28 weeks followed by a 28-week safety follow-up period.
Group XVIII: Part 1 (Dose Finding) Cohort 2: PlaceboPlacebo Group1 Intervention
Participants will receive matching placebo to dose level 2, Q4W, for 28 weeks followed by a 28-week safety follow-up period.
Group XIX: Part 1 (Dose Finding) Cohort 3: PlaceboPlacebo Group1 Intervention
Participants will receive matching placebo to dose level 3, Q4W, for 28 weeks followed by a 28-week safety follow-up period.
Group XX: Part 1 (Dose Finding) Cohort 4: PlaceboPlacebo Group1 Intervention
Participants will receive matching placebo to dose level 4, Q4W, for 28 weeks followed by a 28-week safety follow-up period.
Group XXI: Part 2 (Expansion) Cohort 1: PlaceboPlacebo Group1 Intervention
Participants will receive matching placebo to dose level 1, Q4W, for 28 weeks followed by a 28-week safety follow-up period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RO7126209
2019
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,431 Previous Clinical Trials
1,089,783 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,655 Total Patients Enrolled

Media Library

RO7126209 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04639050 — Phase 1 & 2
Alzheimer's Disease Research Study Groups: Part 2 (Expansion) Cohort 3: Dose Level 3 of RO7126209, Part 2 (Expansion) Cohort 3: Placebo, Part 1 (Dose Finding) Cohort 5: Placebo, Part 1 (Dose Finding) Cohort 5: Dose Level 5 of RO7126209, Part 2 (Expansion) Cohort 2: Placebo, Part 4 OLE Phase Arm 3: RO7126209, Part 4: Open Label Extension (OLE) phase Arm 1: RO7126209, Part 4 OLE Phase Arm 2: RO7126209, Part 2 (Expansion) Cohort 2: Dose Level 2 of RO7126209, Part 1 (Dose Finding) Cohort 1: Dose Level 1 of RO7126209, Part 1 (Dose Finding) Cohort 1: Placebo, Part 1 (Dose Finding) Cohort 2: Dose Level 2 of RO7126209, Part 1 (Dose Finding) Cohort 2: Placebo, Part 1 (Dose Finding) Cohort 3: Dose Level 3 of RO7126209, Part 1 (Dose Finding) Cohort 3: Placebo, Part 1 (Dose Finding) Cohort 4: Placebo, Part 1 (Dose Finding) Cohort 4: Dose Level 4 of RO7126209, Part 2 (Expansion) Cohort 1: Placebo, Part 2 (Expansion) Cohort 1: Dose Level 1 of RO7126209, Part 3 (Dose/Frequency/Pharmacodynamic (PD) Relationship): Dose Level 1: RO7126209, Part 3 Dose/Frequency/PD Relationship: Dose Level 2: RO7126209
Alzheimer's Disease Clinical Trial 2023: RO7126209 Highlights & Side Effects. Trial Name: NCT04639050 — Phase 1 & 2
RO7126209 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04639050 — Phase 1 & 2

Frequently Asked Questions

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

Are there still openings for individuals interested in participating in this research program?

"According to information hosted on clinicaltrials.gov, this trial has been actively searching for patients since its initial posting date of March 15th 2021 and the most recent edit was made on November 4th 2022."

Answered by AI

Could you provide the exact count of individuals engaged in this clinical investigation?

"This clinical trial requires 120 qualified participants and is offering enrolment at locations such as Quest Research Institute in Farmington Hills, Michigan and Abington Neurological Associates in Abington. Pennsylvania."

Answered by AI

Does the research embrace individuals above a certain age bracket?

"This trial has set a lower age limit of 50 and an upper boundary of 85, in order to qualify for enrolment."

Answered by AI

Would I qualify to enter this experiment?

"This clinical trial seeks 120 individuals, aged between 50 and 85 with Alzheimer's disease. Furthermore, participants must be able to comprehend tests either independently or through the help of a study partner; provide signed written consent; have frequent contact with the participant; possess fluency in the language used for testings at their site of treatment; show probable mild-to-moderate AD dementia that meets NIA-AA standards (National Institute on Aging - Alzheimer Association); display MMSE scores ranging from 18 to 28 points within 3 months before baseline; present CDR-GS ratings of 0.5, 1., or 2 within 3 months prior to baseline examination"

Answered by AI

Who else is applying?

What state do they live in?
California
Florida
How old are they?
18 - 65
What site did they apply to?
JEM Research LLC
Kerwin Research Center, LLC; Kerwin Research Center, LLC
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Brainshuttle AD: A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7126209 Following Intravenous Infusion in Participants With Prodromal or Mild to Moderate Alzheimer's Disease
2021. "Brainshuttle AD: A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7126209 Following Intravenous Infusion in Participants With Prodromal or Mild to Moderate Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04639050.
All > Alzheimers Disease Dallas
~150 spots leftby Sep 2027
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