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
NCT ID: NCT04639050
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
241 participants
INTERVENTIONAL
2021-03-15
2030-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Part 1 (Dose Finding) Cohort 5: Placebo
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.
Placebo
RO7126209-matching placebo will be administered intravenously as specified in each treatment arm.
Part 2 (Expansion) Cohort 1: Dose Level 3 of RO7126209
Participants will receive multiple doses of RO7126209 at dose level 3, Q4W, for 28 weeks followed by a 28-week safety follow-up period.
RO7126209
RO7126209 will be administered intravenously as specified in each treatment arm.
Part 2 (Expansion) Cohort 1: Placebo
Participants will receive matching placebo to dose level 3, Q4W, for 28 weeks followed by a 28-week safety follow-up period.
Placebo
RO7126209-matching placebo will be administered intravenously as specified in each treatment arm.
Part 2 (Expansion) Cohort 2: Dose Level 4 of RO7126209
Participants will receive multiple doses of RO7126209 at dose level 4, Q4W, for 28 weeks followed by a 28-week safety follow-up period.
RO7126209
RO7126209 will be administered intravenously as specified in each treatment arm.
Part 2 (Expansion) Cohort 2: Placebo
Participants will receive matching placebo to dose level 4, Q4W, for 28 weeks followed by a 28-week safety follow-up period.
Placebo
RO7126209-matching placebo will be administered intravenously as specified in each treatment arm.
Part 2 (Expansion) Cohort 3: Dose Level 5 of RO7126209
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.
RO7126209
RO7126209 will be administered intravenously as specified in each treatment arm.
Part 2 (Expansion) Cohort 3: Placebo
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.
Placebo
RO7126209-matching placebo will be administered intravenously as specified in each treatment arm.
Part 1 (Dose Finding) Cohort 5: Dose Level 5 of RO7126209
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.
RO7126209
RO7126209 will be administered intravenously as specified in each treatment arm.
Part 1 (Dose Finding) Cohort 1: Dose Level 1 of RO7126209
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.
RO7126209
RO7126209 will be administered intravenously as specified in each treatment arm.
Part 1 (Dose Finding) Cohort 1: Placebo
Participants will receive matching placebo to dose level 1 Q4W for 28 weeks followed by a 28-week safety follow-up period.
Placebo
RO7126209-matching placebo will be administered intravenously as specified in each treatment arm.
Part 1 (Dose Finding) Cohort 2: Dose Level 2 of RO7126209
Participants will receive multiple doses of RO7126209 at dose level 2, Q4W, for 28 weeks followed by a 28-week safety follow-up period.
RO7126209
RO7126209 will be administered intravenously as specified in each treatment arm.
Part 1 (Dose Finding) Cohort 2: Placebo
Participants will receive matching placebo to dose level 2, Q4W, for 28 weeks followed by a 28-week safety follow-up period.
Placebo
RO7126209-matching placebo will be administered intravenously as specified in each treatment arm.
Part 1 (Dose Finding) Cohort 3: Dose Level 3 of RO7126209
Participants will receive multiple doses of RO7126209 at dose level 3, Q4W, for 28 weeks followed by a 28-week safety follow-up period.
RO7126209
RO7126209 will be administered intravenously as specified in each treatment arm.
Part 1 (Dose Finding) Cohort 3: Placebo
Participants will receive matching placebo to dose level 3, Q4W, for 28 weeks followed by a 28-week safety follow-up period.
Placebo
RO7126209-matching placebo will be administered intravenously as specified in each treatment arm.
Part 1 (Dose Finding) Cohort 4: Dose Level 4 of RO7126209
Participants will receive multiple doses of RO7126209 at dose level 4, Q4W, for 28 weeks followed by a 28-week safety follow-up period.
RO7126209
RO7126209 will be administered intravenously as specified in each treatment arm.
Part 1 (Dose Finding) Cohort 4: Placebo
Participants will receive matching placebo to dose level 4, Q4W, for 28 weeks followed by a 28-week safety follow-up period.
Placebo
RO7126209-matching placebo will be administered intravenously as specified in each treatment arm.
Part 3 (Dose/Frequency/Pharmacodynamic (PD) Relationship): Dose Level 1: RO7126209
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.
RO7126209
RO7126209 will be administered intravenously as specified in each treatment arm.
Part 3 Dose/Frequency/PD Relationship: Dose Level 2: RO7126209
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.
RO7126209
RO7126209 will be administered intravenously as specified in each treatment arm.
Part 4: Open Label Extension (OLE)
Participants who completed Part 1, 2, or 3 will receive RO7126209 for a maximum of 205 weeks.
RO7126209
RO7126209 will be administered intravenously as specified in each treatment arm.
Interventions
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RO7126209
RO7126209 will be administered intravenously as specified in each treatment arm.
Placebo
RO7126209-matching placebo will be administered intravenously as specified in each treatment arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
* 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
Exclusion Criteria
* 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)
* 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
50 Years
85 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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JEM Research LLC
Atlantis, Florida, United States
K2 Medical Research-Winter Garden
Clermont, Florida, United States
K2 Medical Research - The Villages
Lady Lake, Florida, United States
K2 Medical Research, LLC
Maitland, Florida, United States
Optimus U Corp
Miami, Florida, United States
Charter Research - Winter Park/Orlando
Orlando, Florida, United States
Advent Health Orlando
Orlando, Florida, United States
Alzheimer's Research and Treatment Center
Stuart, Florida, United States
Charter Research - Lady Lake/The Villages
The Villages, Florida, United States
Alzheimer?s Research and Treatment Center
Wellington, Florida, United States
Conquest Research, LLC
Winter Park, Florida, United States
Alzheimer's Research and Treatment Center - Columbus
Columbus, Georgia, United States
Center for Advanced Research & Education
Gainesville, Georgia, United States
Quest Research Institute
Farmington Hills, Michigan, United States
Summit Research Network Inc.
Portland, Oregon, United States
Abington Neurological Associates
Abington, Pennsylvania, United States
Kerwin Research Center, LLC
Dallas, Texas, United States
Heidelberg Repatriation Hospital
Heidelberg West, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Richmond Clinical Trials
Richmond, British Columbia, Canada
Toronto Memory Program
Toronto, Ontario, Canada
Centro de Investigación Clínica UC-CICUC
Santiago, , Chile
Hospital Clinico Univ de Chile
Santiago, , Chile
Yokohama City Minato Red Cross Hospital
Kanagawa, , Japan
Koseikai Takeda Hospital
Kyoto, , Japan
National Hospital Organization Utano National Hospital
Kyoto, , Japan
Keio University Hospital
Tokyo, , Japan
Tokyo Metropolitan Geriatric Hospital
Tokyo, , Japan
Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital
Tokyo, , Japan
Osrodek Badan Klinicznych Euromedis
Szczecin, , Poland
NZOZ WCA
Wroc?aw, , Poland
Inha University Hospital
Incheon, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital General De Catalunya
Sant Cugat del Vallès, Barcelona, Spain
Policlínica Guipuzcoa
Donostia / San Sebastian, Guipuzcoa, Spain
Fundación ACE
Barcelona, , Spain
Hospital Clinic i Provincial
Barcelona, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Dr. Peset
Valencia, , Spain
Hospital Universitario la Fe
Valencia, , Spain
UCL Institute of Neurology
London, , United Kingdom
Countries
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Other Identifiers
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2020-002477-98
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-509678-52-00
Identifier Type: OTHER
Identifier Source: secondary_id
BP42155
Identifier Type: -
Identifier Source: org_study_id