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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

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ClinicalTrials.gov Identifier: NCT04639050
Recruitment Status : Recruiting
First Posted : November 20, 2020
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief 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.

Condition or disease Intervention/treatment Phase
Alzheimers Disease Drug: RO7126209 Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : March 18, 2021
Estimated Primary Completion Date : October 3, 2024
Estimated Study Completion Date : October 3, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: RO7126209
RO7126209 will be administered via intravenous (IV) infusion, Q4W for a total of seven doses during 28 weeks of treatment.

Placebo Comparator: 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.
Drug: Placebo
Matching placebo will be administered via IV infusion, Q4W for a total of seven doses during 28 weeks of treatment.
Other Name: RO727-5887, F01-01

Experimental: Cohort 2: Dose Level 2 of RO7126209
Participants will receive multiple doses of RO7126209 at dose level 2 once every 4 weeks (Q4W) for 28 weeks followed by a 28-week safety follow-up period.
Drug: RO7126209
RO7126209 will be administered via intravenous (IV) infusion, Q4W for a total of seven doses during 28 weeks of treatment.

Placebo Comparator: 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.
Drug: Placebo
Matching placebo will be administered via IV infusion, Q4W for a total of seven doses during 28 weeks of treatment.
Other Name: RO727-5887, F01-01

Experimental: Cohort 3: Dose Level 3 of RO7126209
Participants will receive multiple doses of RO7126209 at dose level 3 once every 4 weeks (Q4W) for 28 weeks followed by a 28-week safety follow-up period.
Drug: RO7126209
RO7126209 will be administered via intravenous (IV) infusion, Q4W for a total of seven doses during 28 weeks of treatment.

Placebo Comparator: 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.
Drug: Placebo
Matching placebo will be administered via IV infusion, Q4W for a total of seven doses during 28 weeks of treatment.
Other Name: RO727-5887, F01-01

Experimental: Cohort : Dose Level 4 of RO7126209
Participants will receive multiple doses of RO7126209 at dose level 4 once every 4 weeks (Q4W) for 28 weeks followed by a 28-week safety follow-up period.
Drug: RO7126209
RO7126209 will be administered via intravenous (IV) infusion, Q4W for a total of seven doses during 28 weeks of treatment.

Placebo Comparator: 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.
Drug: Placebo
Matching placebo will be administered via IV infusion, Q4W for a total of seven doses during 28 weeks of treatment.
Other Name: RO727-5887, F01-01




Primary Outcome Measures :
  1. Percentage of Participants With Adverse Events (AEs), Including Dose-Limiting Adverse Events (DLAEs) [ Time Frame: Up to 56 weeks ]

Secondary Outcome Measures :
  1. Change From Baseline in Brain Amyloid Load as Measured by Amyloid Positron Emission Tomography (PET) Scan [ Time Frame: Baseline, Week 12 (Cohorts 3 and 4 only), Week 28 ]
  2. Plasma Concentration of RO7126209 [ Time Frame: Up to 32 weeks ]
  3. Cerebral Spinal Fluid (CSF) Concentration of RO7126209 [ Time Frame: Baseline, Week 25 ]
  4. Number of Participants With Anti-Drug Antibodies (ADAs) to RO7126209 [ Time Frame: Up to 56 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key 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
  • Clinical Dementia Rating-Global Score (CDR-GS) of 0.5, 1, or 2
  • Positive amyloid PET scan (cut-off: >50 Centiloid units)
  • 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

Key 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04639050


Contacts
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Contact: Reference Study ID Number: BP42155 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Locations
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United States, Florida
JEM Research LLC Recruiting
Atlantis, Florida, United States, 33462
Brain Matters Research, Inc. Recruiting
Delray Beach, Florida, United States, 33445
Progressive Medical Research Not yet recruiting
Port Orange, Florida, United States, 32127
United States, Michigan
Quest Research Institute Recruiting
Farmington Hills, Michigan, United States, 48334
United States, Pennsylvania
Abington Neurological Associates Recruiting
Abington, Pennsylvania, United States, 19001
United States, Texas
Kerwin Research Center, LLC; Kerwin Research Center, LLC Recruiting
Dallas, Texas, United States, 75231
Australia, Victoria
Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre Not yet recruiting
Heidelberg West, Victoria, Australia, 3081
Alfred Hospital; Department of Neurology Not yet recruiting
Melbourne, Victoria, Australia, 3004
Poland
Osrodek Badan Klinicznych Euromedis Not yet recruiting
Szczecin, Poland, 70-111
NZOZ WCA Not yet recruiting
Wrocław, Poland, 53-659
Spain
Hospital General De Catalunya; Servicio de Neurologia Recruiting
Sant Cugat del Valles, Barcelona, Spain, 8195
Fundación ACE; Servicio de Neurología Recruiting
Barcelona, Spain, 08028
Hospital Clinic i Provincial; Servicio de Neurologia Recruiting
Barcelona, Spain, 08036
Hospital Universitario Dr. Peset; Servicio de Neurologia Recruiting
Valencia, Spain, 46017
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04639050    
Other Study ID Numbers: BP42155
2020-002477-98 ( EudraCT Number )
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders