RO7126209 for Alzheimer's Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Alzheimer's DiseaseRO7126209 - Drug
Eligibility
50 - 85
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Alzheimer's Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Baseline, Week 12 (Cohorts 3 and 4 only), Week 28

Week 28
Change From Baseline in Brain Amyloid Load as Measured by Amyloid Positron Emission Tomography (PET) Scan
Baseline, Week 25
Cerebral Spinal Fluid (CSF) Concentration of RO7126209
Up to 32 weeks
Plasma Concentration of RO7126209
Up to 56 weeks
Number of Participants With Anti-Drug Antibodies (ADAs) to RO7126209
Percentage of Participants With Adverse Events (AEs), Including Dose-Limiting Adverse Events (DLAEs)

Trial Safety

Safety Progress

1 of 3

Side Effects for

RO7126209 (0.4 mg/kg)
25%Back pain
25%Headache
This histogram enumerates side effects from a completed 2020 Phase 1 trial (NCT04023994) in the RO7126209 (0.4 mg/kg) ARM group. Side effects include: Back pain with 25%, Headache with 25%.

Trial Design

8 Treatment Groups

Cohort 2: Dose Level 2 of RO7126209
1 of 8
Cohort 3: Dose Level 3 of RO7126209
1 of 8
Cohort : Dose Level 4 of RO7126209
1 of 8
Cohort 1: Dose Level 1 of RO7126209
1 of 8
Cohort 2: Placebo
1 of 8
Cohort 3: Placebo
1 of 8
Cohort 4: Placebo
1 of 8
Cohort 1: Placebo
1 of 8

Experimental Treatment

Non-Treatment Group

120 Total Participants · 8 Treatment Groups

Primary Treatment: RO7126209 · Has Placebo Group · Phase 1 & 2

Cohort 2: Dose Level 2 of RO7126209
Drug
Experimental Group · 1 Intervention: RO7126209 · Intervention Types: Drug
Cohort 3: Dose Level 3 of RO7126209
Drug
Experimental Group · 1 Intervention: RO7126209 · Intervention Types: Drug
Cohort : Dose Level 4 of RO7126209
Drug
Experimental Group · 1 Intervention: RO7126209 · Intervention Types: Drug
Cohort 1: Dose Level 1 of RO7126209
Drug
Experimental Group · 1 Intervention: RO7126209 · Intervention Types: Drug
Cohort 2: Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Cohort 3: Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Cohort 4: Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Cohort 1: Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RO7126209
2019
Completed Phase 1
~40

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 12 (cohorts 3 and 4 only), week 28

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,360 Previous Clinical Trials
1,067,521 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,146 Previous Clinical Trials
875,575 Total Patients Enrolled

Eligibility Criteria

Age 50 - 85 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are able to complete assessments either alone or with the help of the study partner.
You have a MMSE score of 18 to 28 points, inclusive, within 3 months before baseline.
The patient has a clinical dementia rating of 0.5, 1, or 2 within 3 months before baseline.
Positive amyloid PET scan (cut-off: >50 Centiloid units) within 12 months before baseline.
You have adequate visual and auditory acuity, in the Investigator's judgment, sufficient to perform the neuropsychological testing.
You are willing and able to complete all aspects of the study.

Who else is applying?

What state do they live in?
Florida100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
JEM Research LLC100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%