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
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
Side Effects for
RO7126209 (0.4 mg/kg)
25%Back pain
25%Headache
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: DrugCohort 3: Dose Level 3 of RO7126209
Drug
Experimental Group · 1 Intervention: RO7126209 · Intervention Types: DrugCohort : Dose Level 4 of RO7126209
Drug
Experimental Group · 1 Intervention: RO7126209 · Intervention Types: DrugCohort 1: Dose Level 1 of RO7126209
Drug
Experimental Group · 1 Intervention: RO7126209 · Intervention Types: DrugCohort 2: Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugCohort 3: Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugCohort 4: Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugCohort 1: Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTreatment
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?
| Florida | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| JEM Research LLC | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
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Conditions
Cancer Related
Treatments