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Clinical Trials in the UK / NCT04639050
Active, not recruiting Phase 1/Phase 2

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

NCT04639050 · tracked via the Priya Life Science UK tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 1/Phase 2
Started
2021-03-15
Last updated
2026-09-14

Condition(s) studied

Alzheimers Disease

Investigational drug(s) / intervention(s)

RO7126209Placebo

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.

Study 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 tomography (PET) scan.

Eligibility

Sex
ALL
Min age
50 Years
Max age
85 Years
Healthy volunteers
No
Key inclusion criteria for part 1, 2 and 3: * 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) * 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 Inclusion criteria for Part 4: \- Completed the treatment period in Part 1, Part 2, or Part 3 of the study Key exclusion criteria for part 1, 2 and 3: * 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 * 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 Exclusion criteria for Part 4: * 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

Primary outcome measure(s)

Trial sites (37)

FacilityCityRegionStatus
JEM Research LLC Atlantis Florida
K2 Medical Research-Winter Garden Clermont Florida
K2 Medical Research - The Villages Lady Lake Florida
K2 Medical Research, LLC Maitland Florida
Optimus U Corp Miami Florida
Charter Research - Winter Park/Orlando Orlando Florida
Alzheimer's Research and Treatment Center Stuart Florida
Charter Research - Lady Lake/The Villages The Villages Florida
Alzheimer?s Research and Treatment Center Wellington Florida
Conquest Research, LLC Winter Park Florida
Alzheimer's Research and Treatment Center - Columbus Columbus Georgia
Center for Advanced Research & Education Gainesville Georgia
Quest Research Institute Farmington Hills Michigan
Abington Neurological Associates Abington Pennsylvania
Kerwin Research Center, LLC Dallas Texas
Heidelberg Repatriation Hospital Heidelberg West Victoria
Alfred Hospital Melbourne Victoria
Richmond Clinical Trials Richmond British Columbia
Toronto Memory Program Toronto Ontario
Centro de Investigación Clínica UC-CICUC Santiago Chile
Hospital Clinico Univ de Chile Santiago Chile
Koseikai Takeda Hospital Kyoto Japan
National Hospital Organization Utano National Hospital Kyoto Japan
Keio University Hospital Tokyo Japan
Tokyo Metropolitan Institute for Geriatrics and Gerontology 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
Policlínica Guipuzcoa Donostia / San Sebastian Guipuzcoa
Fundación ACE Barcelona Spain
Hospital Clinic i Provincial Barcelona Spain
Hospital Universitario 12 de Octubre Madrid Spain
Hospital Universitario Dr. Peset Valencia Spain
UCL Institute of Neurology London United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04639050 on ClinicalTrials.gov ↗ ← All trials in the UK