Active — Not RecruitingPhase 1/2

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

United States, Australia, Canada241 participantsStarted 2021-03-15

Plain-language 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.

Who can participate

Age range

50 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 r…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is in Phase 1/2 and is no longer recruiting — what does that mean for my situation, and is there a follow-on or later-phase trial for RO7126209 that might be worth looking into?
2Since one of the main things this trial is measuring is whether the drug is safe and tolerable through intravenous infusion, what do we know so far about the types of side effects participants have experienced, and how would those risks compare to my current options?
3The trial is tracking changes in brain amyloid using PET scans — given my current diagnosis of prodromal or mild to moderate Alzheimer's, would reducing amyloid load actually translate into a meaningful benefit for me, or is that still an open question?
4This drug is given by IV infusion across multiple doses — if I were considering a trial like this, how would the infusion schedule and monitoring visits realistically fit into my life and health situation?
5Are there already approved treatments or other active trials targeting amyloid that my care team thinks I should consider before or instead of an early-phase study like this one?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part 1, 2, 3, and 4: Percentage of Participants With Adverse Events (AEs)

Timeframe: 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

Timeframe: Up to approximately 24 weeks

Trial details

NCT IDNCT04639050

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07-31

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