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

  • STATUS
    Recruiting
  • End date
    Oct 3, 2024
  • participants needed
    120
  • sponsor
    Hoffmann-La Roche
Updated on 26 July 2022
cognitive impairment
positron emission tomography
dementia
mini-mental state examination
mild cognitive impairment
amyloid
mental state examination
apolipoprotein e

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.

Details
Condition Alzheimers Disease
Treatment Placebo, RO7126209
Clinical Study IdentifierNCT04639050
SponsorHoffmann-La Roche
Last Modified on26 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Alzheimer's Disease (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 3 months before baseline
Clinical Dementia Rating-Global Score (CDR-GS) 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
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

Exclusion Criteria

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, 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, 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
Combined number of microhemorrhages and focal areas of leptomeningeal hemosiderosis (i.e., cumulative amyloid-related imaging abnormality-microhemorrhage/hemosiderin deposition [ARIA-H]) on MRI more than 5 (and should not include more than 3 focal areas 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
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