Alzheimers DiseasePhase 1/2NCT04639050
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
A Phase 1/2 study testing RO7126209 in people with Alzheimers Disease, run by Hoffmann-La Roche at 37 sites in 9 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics of multiple-ascending intravenous (IV) doses of RO7126209 in participants with prodromal or mild to moderate Alzheimer's disease (AD), who are amyloid positive based on amyloid positron emission… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimers Disease
- What is being tested?
- RO7126209
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 241 participants
- Where
- 37 sitesin 9 countries
- Study dates
- 15 Mar 2021to 31 Jul 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to provide written consent signed by the participant
- Availability of a person (referred to as the "study partner") who: consents to participate throughout the duration of study, in the Investigator's judgment, has frequent and sufficient contact with the participant, is fluent in the language of the tests used at the study site
- Willingness and ability to complete all aspects of the study (including magnetic resonance imaging [MRI], lumbar puncture, clinical genotyping, and positron emission tomography [PET] imaging)
- Capable of completing assessments either alone or with the help of the study partner
- Adequate visual and auditory acuity, in the Investigator's judgment, sufficient to perform the neuropsychological testing (eye glasses and hearing aids are permitted)
- Probable mild to moderate 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)
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- Screening Mini-Mental State Examination (MMSE) score of 18 to 28 points, inclusive, within 84 days before baseline
- Clinical Dementia Rating-Global Score (CDR-GS) of 0.5, 1, or 2 within 84 days before baseline
- Positive amyloid PET scan (cut-off: >50 Centiloid units) within 12 months before baseline
- In case of treatment with symptomatic AD medications, dosing regimen must be stable for at least 8 weeks prior to baseline and until randomization
- Agreement not to donate blood or blood products for transfusion for the duration of the study and for 1 year after final dose of study drug
- Agreement not to participate in other research studies for the duration of this study
- Agree to apolipoprotein E (APOE) genotyping
- Completed the treatment period in Part 1, Part 2, or Part 3 of the study
Who cannot join
- Any evidence of other relevant neurological condition, including other (non-AD) neurodegenerative and neuropsychiatric conditions, neurovascular brain disorders, seizure disorders, inflammatory and infectious disorders of the central nervous system, trauma and delirium, among several others
- Other relevant medical conditions including significant hematological diseases, any clinically significant ophthalmologic diseases, decreased visual acuity in either eye, with a BCVA letter score of less than 20 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart or the Snellen equivalent of 20/400 if the ETDRS chart is not used
- Clinically significant cardiovascular diseases, chronic kidney disease, confirmed and unexplained impaired hepatic function, abnormal thyroid function, among several others
- History of hypersensitivity to biologic agents or any of the excipients in the formulation
- Clinically significant abnormalities (as judged by the Investigator) in laboratory test results (including complete blood count, chemistry panel, routine cerebrospinal fluid [CSF] parameters and urinalysis)
- MRI exclusion criteria: >2 lacunar infarcts (including lacunar infarcts in the cerebellum), any territorial infarct >1 cm^3, any white matter lesion that corresponds to an overall Fazekas score of 3 that requires at least one confluent hyperintense lesion on the fluid-attenuated inversion recovery (FLAIR) sequence, which is ≥20 mm in any dimension
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- More than 4 microhemorrhages on MRI and/or presence of any focal area of leptomeningeal hemosiderosis based on the review performed by the central MRI reader prior to randomization
- Presence of any other significant cerebral abnormalities, including amyloid-related imaging abnormality-edema/effusion (ARIA-E), as assessed on MRI
- Inability to tolerate MRI procedures or contraindication to MRI
- Inability to undergo ophthalmological assessments
- Contraindication to lumbar puncture
- Contraindication to having a PET scan
- Prematurely discontinued from the treatment period for study (i.e., before the start of the follow-up period of Part 1, Part 2, or Part 3) for any reason or meeting discontinuation criteria before the baseline visit of Part 4.
- Received any active investigational treatment other than RO7126209 during or since completion of Part 1, Part 2 or Part 3
- Any passive immunotherapy (immunoglobulin) since completion of Part 1, Part 2, or Part 3 that is meant to prevent or postpone cognitive decline.
- Use of anti-coagulation medications - Evidence of ongoing ARIA-E. In this case participant may enroll into Part 4 once the ARIA-E is resolved - Evidence of ongoing infusion-related reaction (IRR) or hypersensitivity reaction. In this case participant may enroll into Part 4 once the IRR is resolved.
- MRI evidence of any of the following at OLE baseline: evidence of ongoing ARIA-E, any ARIA-H (leptomeningeal hemosiderosis or microhemorrhages) that would require permanent discontinuation of study treatment, > 2 lacunar infarcts, Any territorial infarct > 1 cm^3, any white matter lesion that corresponds to an overall Fazekas score of 3 that requires at least one confluent hyperintense lesion on the FLAIR sequence, which is ≥ 20 mm in any dimension
- Any drop in hemoglobin of > 20% compared to predose on Day 1 or hemoglobin value below 10 g/dL
Trial locations and contacts
37 sites in 9 countries.
37 sites in 9 countries
United States15 sites
Abington Neurological Associates
Abington, Pennsylvania, 19001
JEM Research LLC
Atlantis, Florida, 33462
K2 Medical Research-Winter Garden
Clermont, Florida, 34711
Alzheimer's Research and Treatment Center - Columbus
Columbus, Georgia, 31904
Kerwin Research Center, LLC
Dallas, Texas, 75231
Quest Research Institute
Farmington Hills, Michigan, 48334
Center for Advanced Research & Education
Gainesville, Georgia, 30501
K2 Medical Research - The Villages
Lady Lake, Florida, 32159
K2 Medical Research, LLC
Maitland, Florida, 32751
Optimus U Corp
Miami, Florida, 33135
Charter Research - Winter Park/Orlando
Orlando, Florida, 32803
Alzheimer's Research and Treatment Center
Stuart, Florida, 34996
Charter Research - Lady Lake/The Villages
The Villages, Florida, 32162
Alzheimer?s Research and Treatment Center
Wellington, Florida, 33414
Conquest Research, LLC
Winter Park, Florida, 32789
Spain6 sites
Fundación ACE
Barcelona, 08028
Hospital Clinic i Provincial
Barcelona, 08036
Policlínica Guipuzcoa
Donostia / San Sebastian, Guipuzcoa, 20014
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital General De Catalunya
Sant Cugat del Vallès, Barcelona, 8195
Hospital Universitario Dr. Peset
Valencia, 46017
Japan5 sites
Koseikai Takeda Hospital
Kyoto, 600-8558
National Hospital Organization Utano National Hospital
Kyoto, 616-8255
Keio University Hospital
Tokyo, 160-8582
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Tokyo, 173-0015
Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital
Tokyo, 190-8531
Australia2 sites
Heidelberg Repatriation Hospital
Heidelberg West, Victoria, 3081
Alfred Hospital
Melbourne, Victoria, 3004
Canada2 sites
Richmond Clinical Trials
Richmond, British Columbia, V6V 2L1
Toronto Memory Program
Toronto, Ontario, M3B 2S7
Chile2 sites
Centro de Investigación Clínica UC-CICUC
Santiago, 8330034
Hospital Clinico Univ de Chile
Santiago, 8380456
Poland2 sites
Osrodek Badan Klinicznych Euromedis
Szczecin, 70-111
NZOZ WCA
Wroc?aw, 53-659
South Korea2 sites
Inha University Hospital
Incheon, 22332
Samsung Medical Center
Seoul, 06351
About this study
Official title: A Phase Ib/IIa, Randomized, Double Blind, Placebo-Controlled, Multiple Ascending Dose, Parallel-Group Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7126209 Following Intravenous Infusion in Patients With Prodromal or Mild to Moderate Alzheimer's Disease
The purpose of this study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics of multiple-ascending intravenous (IV) doses of RO7126209 in participants with prodromal or mild to moderate Alzheimer's disease (AD), who are amyloid positive based on amyloid positron emission tomography (PET) scan.
- Conditions
- Alzheimers Disease
- Being tested
- RO7126209, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7126209Drug
Also called Trontinemab, RG6102
RO7126209 will be administered intravenously as specified in each treatment arm.
PlaceboDrug
Also called RO727-5887, F01-01
RO7126209-matching placebo will be administered intravenously as specified in each treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (Dose Finding) Cohort 1: Dose Level 1 of RO7126209 | Experimental | 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. Receives: Drug: RO7126209 |
| Part 1 (Dose Finding) Cohort 1: Placebo | Placebo comparator | Participants will receive matching placebo to dose level 1 Q4W for 28 weeks followed by a 28-week safety follow-up period. Receives: Drug: Placebo |
| Part 1 (Dose Finding) Cohort 2: Dose Level 2 of RO7126209 | Experimental | Participants will receive multiple doses of RO7126209 at dose level 2, Q4W, for 28 weeks followed by a 28-week safety follow-up period. Receives: Drug: RO7126209 |
| Part 1 (Dose Finding) Cohort 2: Placebo | Placebo comparator | Participants will receive matching placebo to dose level 2, Q4W, for 28 weeks followed by a 28-week safety follow-up period. Receives: Drug: Placebo |
| Part 1 (Dose Finding) Cohort 3: Dose Level 3 of RO7126209 | Experimental | Participants will receive multiple doses of RO7126209 at dose level 3, Q4W, for 28 weeks followed by a 28-week safety follow-up period. Receives: Drug: RO7126209 |
| Part 1 (Dose Finding) Cohort 3: Placebo | Placebo comparator | Participants will receive matching placebo to dose level 3, Q4W, for 28 weeks followed by a 28-week safety follow-up period. Receives: Drug: Placebo |
| Part 1 (Dose Finding) Cohort 4: Dose Level 4 of RO7126209 | Experimental | Participants will receive multiple doses of RO7126209 at dose level 4, Q4W, for 28 weeks followed by a 28-week safety follow-up period. Receives: Drug: RO7126209 |
| Part 1 (Dose Finding) Cohort 4: Placebo | Placebo comparator | Participants will receive matching placebo to dose level 4, Q4W, for 28 weeks followed by a 28-week safety follow-up period. Receives: Drug: Placebo |
| Part 1 (Dose Finding) Cohort 5: Dose Level 5 of RO7126209 | Experimental | 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. Receives: Drug: RO7126209 |
| Part 1 (Dose Finding) Cohort 5: Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
| Part 2 (Expansion) Cohort 1: Dose Level 3 of RO7126209 | Experimental | Participants will receive multiple doses of RO7126209 at dose level 3, Q4W, for 28 weeks followed by a 28-week safety follow-up period. Receives: Drug: RO7126209 |
| Part 2 (Expansion) Cohort 1: Placebo | Placebo comparator | Participants will receive matching placebo to dose level 3, Q4W, for 28 weeks followed by a 28-week safety follow-up period. Receives: Drug: Placebo |
| Part 2 (Expansion) Cohort 2: Dose Level 4 of RO7126209 | Experimental | Participants will receive multiple doses of RO7126209 at dose level 4, Q4W, for 28 weeks followed by a 28-week safety follow-up period. Receives: Drug: RO7126209 |
| Part 2 (Expansion) Cohort 2: Placebo | Placebo comparator | Participants will receive matching placebo to dose level 4, Q4W, for 28 weeks followed by a 28-week safety follow-up period. Receives: Drug: Placebo |
| Part 2 (Expansion) Cohort 3: Dose Level 5 of RO7126209 | Experimental | 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. Receives: Drug: RO7126209 |
| Part 2 (Expansion) Cohort 3: Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
| Part 3 (Dose/Frequency/Pharmacodynamic (PD) Relationship): Dose Level 1: RO7126209 | Experimental | 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. Receives: Drug: RO7126209 |
| Part 3 Dose/Frequency/PD Relationship: Dose Level 2: RO7126209 | Experimental | 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. Receives: Drug: RO7126209 |
| Part 4: Open Label Extension (OLE) | Experimental | Participants who completed Part 1, 2, or 3 will receive RO7126209 for a maximum of 205 weeks. Receives: Drug: RO7126209 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1, 2, 3, and 4: Percentage of Participants With Adverse Events (AEs)
Measured: Part 1 and 2: Up to approximately 56 weeks; Part 3: Up to approximately 52 weeks; Part 4: Up to approximately 233 weeks
Part 3: Change From Baseline in Brain Amyloid Load as Measured by Amyloid Positron Emission Tomography (PET) Scan
Measured: Up to approximately 24 weeks
Secondary outcomes (4)
Part 1, 2, and 4: Change From Baseline in Brain Amyloid Load as Measured by Amyloid PET Scan
Measured: Part 1 and 2: Up to approximately 28 weeks; Part 4: Up to approximately 205 weeks
Part 1, 2, 3, and 4: Plasma Concentration of RO7126209
Measured: Part 1 and 2: Up to approximately 32 weeks; Part 3: Up to approximately 24 weeks; Part 4: Up to approximately 209 weeks
Part 1, 2, 3, and 4: Cerebral Spinal Fluid (CSF) Concentration of RO7126209
Measured: Part 1 and 2: Up to approximately 25 weeks; Part 3: Up to approximately 21 weeks; Part 4: Up to approximately 205 weeks
Part 1, 2, 3, and 4: Number of Participants With Anti-Drug Antibodies (ADAs) to RO7126209
Measured: Part 1 and 2: Up to approximately 56 weeks; Part 3: Up to approximately 52 weeks; Part 4: Up to approximately 233 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start15 Mar 2021
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimers DiseaseStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639050
- Sponsor's protocol ID
- BP42155
- Other IDs
- 2020-002477-98, 2023-509678-52-00, 2023
- Status last verified
- Sep 2026
- First submitted
- 17 Nov 2020
- Last updated
- 14 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/IIa, Randomized, Double Blind, Placebo-Controlled, Multiple Ascending Dose, Parallel-Group Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7126209 Following Intravenous Infusion in Patients With Prodromal or Mild to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04639050
- Acronym / sponsor ID
- BP42155
- Conditions
- Alzheimers Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics of multiple-ascending intravenous (IV) doses of RO7126209 in participants with prodromal or mild to moderate Alzheimer's disease (AD), who are amyloid positive based on amyloid positron emission tomography (PET) scan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 19
| Arm | Type | Receives |
|---|---|---|
| Part 1 (Dose Finding) Cohort 1: Dose Level 1 of RO7126209 | Experimental | Drug: RO7126209Participants 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. |
| Part 1 (Dose Finding) Cohort 1: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo to dose level 1 Q4W for 28 weeks followed by a 28-week safety follow-up period. |
| Part 1 (Dose Finding) Cohort 2: Dose Level 2 of RO7126209 | Experimental | Drug: RO7126209Participants will receive multiple doses of RO7126209 at dose level 2, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
| Part 1 (Dose Finding) Cohort 2: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo to dose level 2, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
| Part 1 (Dose Finding) Cohort 3: Dose Level 3 of RO7126209 | Experimental | Drug: RO7126209Participants will receive multiple doses of RO7126209 at dose level 3, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
| Part 1 (Dose Finding) Cohort 3: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo to dose level 3, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
| Part 1 (Dose Finding) Cohort 4: Dose Level 4 of RO7126209 | Experimental | Drug: RO7126209Participants will receive multiple doses of RO7126209 at dose level 4, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
| Part 1 (Dose Finding) Cohort 4: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo to dose level 4, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
| Part 1 (Dose Finding) Cohort 5: Dose Level 5 of RO7126209 | Experimental | Drug: RO7126209Participants 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. |
| Part 1 (Dose Finding) Cohort 5: Placebo | Placebo comparator | Drug: PlaceboParticipants 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. |
| Part 2 (Expansion) Cohort 1: Dose Level 3 of RO7126209 | Experimental | Drug: RO7126209Participants will receive multiple doses of RO7126209 at dose level 3, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
| Part 2 (Expansion) Cohort 1: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo to dose level 3, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
| Part 2 (Expansion) Cohort 2: Dose Level 4 of RO7126209 | Experimental | Drug: RO7126209Participants will receive multiple doses of RO7126209 at dose level 4, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
| Part 2 (Expansion) Cohort 2: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo to dose level 4, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
| Part 2 (Expansion) Cohort 3: Dose Level 5 of RO7126209 | Experimental | Drug: RO7126209Participants 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. |
| Part 2 (Expansion) Cohort 3: Placebo | Placebo comparator | Drug: PlaceboParticipants 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. |
| Part 3 (Dose/Frequency/Pharmacodynamic (PD) Relationship): Dose Level 1: RO7126209 | Experimental | Drug: RO7126209Participants 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. |
| Part 3 Dose/Frequency/PD Relationship: Dose Level 2: RO7126209 | Experimental | Drug: RO7126209Participants 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. |
| Part 4: Open Label Extension (OLE) | Experimental | Drug: RO7126209Participants who completed Part 1, 2, or 3 will receive RO7126209 for a maximum of 205 weeks. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Ability to provide written consent signed by the participant
- Availability of a person (referred to as the "study partner") who: consents to participate throughout the duration of study, in the Investigator's judgment, has frequent and sufficient contact with the participant, is fluent in the language of the tests used at the study site
- Willingness and ability to complete all aspects of the study (including magnetic resonance imaging [MRI], lumbar puncture, clinical genotyping, and positron emission tomography [PET] imaging)
- Capable of completing assessments either alone or with the help of the study partner
- Adequate visual and auditory acuity, in the Investigator's judgment, sufficient to perform the neuropsychological testing (eye glasses and hearing aids are permitted)
Key exclusion criteria (18 listed)
- Any evidence of other relevant neurological condition, including other (non-AD) neurodegenerative and neuropsychiatric conditions, neurovascular brain disorders, seizure disorders, inflammatory and infectious disorders of the central nervous system, trauma and delirium, among several others
- Other relevant medical conditions including significant hematological diseases, any clinically significant ophthalmologic diseases, decreased visual acuity in either eye, with a BCVA letter score of less than 20 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart or the Snellen equivalent of 20/400 if the ETDRS chart is not used
- Clinically significant cardiovascular diseases, chronic kidney disease, confirmed and unexplained impaired hepatic function, abnormal thyroid function, among several others
- History of hypersensitivity to biologic agents or any of the excipients in the formulation
- Clinically significant abnormalities (as judged by the Investigator) in laboratory test results (including complete blood count, chemistry panel, routine cerebrospinal fluid [CSF] parameters and urinalysis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RO7126209Also: Trontinemab, RG6102RO7126209 will be administered intravenously as specified in each treatment arm. | Drug | Part 1 (Dose Finding) Cohort 1: Dose Level 1 of RO7126209, Part 1 (Dose Finding) Cohort 2: Dose Level 2 of RO7126209, Part 1 (Dose Finding) Cohort 3: Dose Level 3 of RO7126209, Part 1 (Dose Finding) Cohort 4: Dose Level 4 of RO7126209, Part 1 (Dose Finding) Cohort 5: Dose Level 5 of RO7126209, Part 2 (Expansion) Cohort 1: Dose Level 3 of RO7126209, Part 2 (Expansion) Cohort 2: Dose Level 4 of RO7126209, Part 2 (Expansion) Cohort 3: Dose Level 5 of RO7126209, Part 3 (Dose/Frequency/Pharmacodynamic (PD) Relationship): Dose Level 1: RO7126209, Part 3 Dose/Frequency/PD Relationship: Dose Level 2: RO7126209, Part 4: Open Label Extension (OLE) |
| PlaceboAlso: RO727-5887, F01-01RO7126209-matching placebo will be administered intravenously as specified in each treatment arm. | Drug | Part 1 (Dose Finding) Cohort 1: Placebo, Part 1 (Dose Finding) Cohort 2: Placebo, Part 1 (Dose Finding) Cohort 3: Placebo, Part 1 (Dose Finding) Cohort 4: Placebo, Part 1 (Dose Finding) Cohort 5: Placebo, Part 2 (Expansion) Cohort 1: Placebo, Part 2 (Expansion) Cohort 2: Placebo, Part 2 (Expansion) Cohort 3: Placebo |
Primary outcome
Part 1, 2, 3, and 4: Percentage of Participants With Adverse Events (AEs)
Time frame: Part 1 and 2: Up to approximately 56 weeks; Part 3: Up to approximately 52 weeks; Part 4: Up to approximately 233 weeks
Part 3: Change From Baseline in Brain Amyloid Load as Measured by Amyloid Positron Emission Tomography (PET) Scan
Time frame: Up to approximately 24 weeks
4 secondary outcomes
Part 1, 2, and 4: Change From Baseline in Brain Amyloid Load as Measured by Amyloid PET Scan
Time frame: Part 1 and 2: Up to approximately 28 weeks; Part 4: Up to approximately 205 weeks
Part 1, 2, 3, and 4: Plasma Concentration of RO7126209
Time frame: Part 1 and 2: Up to approximately 32 weeks; Part 3: Up to approximately 24 weeks; Part 4: Up to approximately 209 weeks
Part 1, 2, 3, and 4: Cerebral Spinal Fluid (CSF) Concentration of RO7126209
Time frame: Part 1 and 2: Up to approximately 25 weeks; Part 3: Up to approximately 21 weeks; Part 4: Up to approximately 205 weeks
Part 1, 2, 3, and 4: Number of Participants With Anti-Drug Antibodies (ADAs) to RO7126209
Time frame: Part 1 and 2: Up to approximately 56 weeks; Part 3: Up to approximately 52 weeks; Part 4: Up to approximately 233 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: Yes. For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
37 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RO7126209 in people with Alzheimers Disease, run by Hoffmann-La Roche at 37 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Spain, Japan, Australia, Canada and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1, 2, 3, and 4: Percentage of Participants With Adverse Events (AEs) (time frame: Part 1 and 2: Up to approximately 56 weeks; Part 3: Up to approximately 52 weeks; Part 4: Up to approximately 233 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.