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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

Primary Purpose

Alzheimers Disease

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
RO7126209
Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimers Disease

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, 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

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

Sites / Locations

  • JEM Research LLC
  • Brain Matters Research, Inc.
  • Progressive Medical Research
  • Quest Research Institute
  • Abington Neurological Associates
  • Kerwin Research Center, LLCRecruiting
  • Heidelberg Repatriation Hospital; Medical and Cognitive Research CentreRecruiting
  • Alfred Hospital; Department of Neurology
  • Yokohama City Minato Red Cross HospitalRecruiting
  • Koseikai Takeda HospitalRecruiting
  • National Hospital Organization Utano National Hospital; NeurologyRecruiting
  • Keio University Hospital; Neurology
  • Tokyo Metropolitan Geriatric HospitalRecruiting
  • Federation of National Public Service Personnel Mutual Aid Associations Tachikawa HospitalRecruiting
  • Osrodek Badan Klinicznych EuromedisRecruiting
  • NZOZ WCARecruiting
  • Hospital General De Catalunya; Servicio de NeurologiaRecruiting
  • Fundación ACE; Servicio de Neurología
  • Hospital Clinic i Provincial; Servicio de Neurologia
  • Hospital Universitario Dr. Peset; Servicio de NeurologiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Part 1 (Dose Finding) Cohort 1: Dose Level 1 of RO7126209

Part 1 (Dose Finding) Cohort 1: Placebo

Part 1 (Dose Finding) Cohort 2: Dose Level 2 of RO7126209

Part 1 (Dose Finding) Cohort 2: Placebo

Part 1 (Dose Finding) Cohort 3: Dose Level 3 of RO7126209

Part 1 (Dose Finding) Cohort 3: Placebo

Part 1 (Dose Finding) Cohort 4: Dose Level 4 of RO7126209

Part 1 (Dose Finding) Cohort 4: Placebo

Part 2 (Expansion) Cohort 1: Dose Level 1 of RO7126209

Part 2 (Expansion) Cohort 1: Placebo

Part 2 (Expansion) Cohort 2: Dose Level 2 of RO7126209

Part 2 (Expansion) Cohort 2: Placebo

Part 3 (Dose/Frequency/Pharmacodynamic (PD) Relationship): Dose Level 1: RO7126209

Part 3 Dose/Frequency/PD Relationship: Dose Level 2: RO7126209

Part 4: Open Label Extension (OLE) phase: RO7126209

Arm Description

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.

Participants will receive matching placebo to dose level 1 Q4W for 28 weeks followed by a 28-week safety follow-up period.

Participants will receive multiple doses of RO7126209 at dose level 2, Q4W, for 28 weeks followed by a 28-week safety follow-up period.

Participants will receive matching placebo to dose level 2, Q4W, for 28 weeks followed by a 28-week safety follow-up period.

Participants will receive multiple doses of RO7126209 at dose level 3, Q4W, for 28 weeks followed by a 28-week safety follow-up period.

Participants will receive matching placebo to dose level 3, Q4W, for 28 weeks followed by a 28-week safety follow-up period.

Participants will receive multiple doses of RO7126209 at dose level 4, Q4W, for 28 weeks followed by a 28-week safety follow-up period.

Participants will receive matching placebo to dose level 4, Q4W, for 28 weeks followed by a 28-week safety follow-up period.

Participants will receive multiple doses of RO7126209 at dose level 1, Q4W, for 28 weeks followed by a 28-week safety follow-up period.

Participants will receive matching placebo to dose level 1, Q4W, for 28 weeks followed by a 28-week safety follow-up period.

Participants will receive multiple doses of RO7126209 at dose level 2, Q4W, for 28 weeks followed by a 28-week safety follow-up period.

Participants will receive matching placebo to dose level 2, Q4W, for 28 weeks followed by a 28-week safety follow-up period.

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.

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.

Participants who completed Part 1, 2, or 3 and have reached amyloid negativity (≤ 24 centiloids) in either of the Study Parts or at the OLE baseline visit will receive RO7126209 Q12W. Those who are amyloid positive (≥24 centiloids) will receive RO7126209 Q4W for 12 weeks and will have to reach amyloid negativity (≤ 24 centiloids) before they can switch to Q12W dosing in an open-label treatment period of 101 weeks followed by a 28-week safety follow-up period.

Outcomes

Primary Outcome Measures

Part 1: Percentage of participants experiencing Dose-limiting adverse events (DLAEs)
Part 1, 2, 3, and 4: Percentage of Participants With Adverse Events (AEs)
Part 3: Change From Baseline in Brain Amyloid Load as Measured by Amyloid Positron Emission Tomography (PET) Scan

Secondary Outcome Measures

Part 1, 2, and 4: Change From Baseline in Brain Amyloid Load as Measured by Amyloid PET Scan
Part 1, 2, 3, and 4: Plasma Concentration of RO7126209
Part 1, 2, 3, and 4: Cerebral Spinal Fluid (CSF) Concentration of RO7126209
Part 1, 2, 3, and 4: Number of Participants With Anti-Drug Antibodies (ADAs) to RO7126209

Full Information

First Posted
November 17, 2020
Last Updated
October 13, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT04639050
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
September 30, 2027 (Anticipated)
Study Completion Date
September 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimers Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1 (Dose Finding) Cohort 1: Dose Level 1 of RO7126209
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 1 (Dose Finding) Cohort 1: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive matching placebo to dose level 1 Q4W for 28 weeks followed by a 28-week safety follow-up period.
Arm Title
Part 1 (Dose Finding) Cohort 2: Dose Level 2 of RO7126209
Arm Type
Experimental
Arm Description
Participants will receive multiple doses of RO7126209 at dose level 2, Q4W, for 28 weeks followed by a 28-week safety follow-up period.
Arm Title
Part 1 (Dose Finding) Cohort 2: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive matching placebo to dose level 2, Q4W, for 28 weeks followed by a 28-week safety follow-up period.
Arm Title
Part 1 (Dose Finding) Cohort 3: Dose Level 3 of RO7126209
Arm Type
Experimental
Arm Description
Participants will receive multiple doses of RO7126209 at dose level 3, Q4W, for 28 weeks followed by a 28-week safety follow-up period.
Arm Title
Part 1 (Dose Finding) Cohort 3: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive matching placebo to dose level 3, Q4W, for 28 weeks followed by a 28-week safety follow-up period.
Arm Title
Part 1 (Dose Finding) Cohort 4: Dose Level 4 of RO7126209
Arm Type
Experimental
Arm Description
Participants will receive multiple doses of RO7126209 at dose level 4, Q4W, for 28 weeks followed by a 28-week safety follow-up period.
Arm Title
Part 1 (Dose Finding) Cohort 4: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive matching placebo to dose level 4, Q4W, for 28 weeks followed by a 28-week safety follow-up period.
Arm Title
Part 2 (Expansion) Cohort 1: Dose Level 1 of RO7126209
Arm Type
Experimental
Arm Description
Participants will receive multiple doses of RO7126209 at dose level 1, Q4W, for 28 weeks followed by a 28-week safety follow-up period.
Arm Title
Part 2 (Expansion) Cohort 1: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive matching placebo to dose level 1, Q4W, for 28 weeks followed by a 28-week safety follow-up period.
Arm Title
Part 2 (Expansion) Cohort 2: Dose Level 2 of RO7126209
Arm Type
Experimental
Arm Description
Participants will receive multiple doses of RO7126209 at dose level 2, Q4W, for 28 weeks followed by a 28-week safety follow-up period.
Arm Title
Part 2 (Expansion) Cohort 2: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive matching placebo to dose level 2, Q4W, for 28 weeks followed by a 28-week safety follow-up period.
Arm Title
Part 3 (Dose/Frequency/Pharmacodynamic (PD) Relationship): Dose Level 1: RO7126209
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 3 Dose/Frequency/PD Relationship: Dose Level 2: RO7126209
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 4: Open Label Extension (OLE) phase: RO7126209
Arm Type
Experimental
Arm Description
Participants who completed Part 1, 2, or 3 and have reached amyloid negativity (≤ 24 centiloids) in either of the Study Parts or at the OLE baseline visit will receive RO7126209 Q12W. Those who are amyloid positive (≥24 centiloids) will receive RO7126209 Q4W for 12 weeks and will have to reach amyloid negativity (≤ 24 centiloids) before they can switch to Q12W dosing in an open-label treatment period of 101 weeks followed by a 28-week safety follow-up period.
Intervention Type
Drug
Intervention Name(s)
RO7126209
Intervention Description
RO7126209 will be administered intravenously as specified in each treatment arm.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
RO727-5887, F01-01
Intervention Description
RO7126209-matching placebo will be administered intravenously as specified in each treatment arm.
Primary Outcome Measure Information:
Title
Part 1: Percentage of participants experiencing Dose-limiting adverse events (DLAEs)
Time Frame
From first dose up to 14 days after the last dose (up to approximately 30 weeks).
Title
Part 1, 2, 3, and 4: Percentage of Participants With Adverse Events (AEs)
Time Frame
Part 1 and 2: Up to approximately 56 weeks; Part 3: Up to approximately 52 weeks; Part 4: Up to approximately 129 weeks
Title
Part 3: Change From Baseline in Brain Amyloid Load as Measured by Amyloid Positron Emission Tomography (PET) Scan
Time Frame
Up to approximately 24 weeks
Secondary Outcome Measure Information:
Title
Part 1, 2, and 4: Change From Baseline in Brain Amyloid Load as Measured by Amyloid PET Scan
Time Frame
Part 1 and 2: Up to approximately 28 weeks; Part 4: Up to approximately 101 weeks
Title
Part 1, 2, 3, and 4: Plasma Concentration of RO7126209
Time Frame
Part 1 and 2: Up to approximately 32 weeks; Part 3: Up to approximately 24 weeks; Part 4: Up to approximately 101 weeks
Title
Part 1, 2, 3, and 4: Cerebral Spinal Fluid (CSF) Concentration of RO7126209
Time Frame
Part 1 and 2: Up to approximately 25 weeks; Part 3: Up to approximately 21 weeks; Part 4: Up to approximately 101 weeks
Title
Part 1, 2, 3, and 4: Number of Participants With Anti-Drug Antibodies (ADAs) to RO7126209
Time Frame
Part 1 and 2: Up to approximately 56 weeks; Part 3: Up to approximately 52 weeks; Part 4: Up to approximately 129 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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, 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 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 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. Any drop in hemoglobin of > 20% compared to baseline or hemoglobin value below 10 g/dL
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: BP42155 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. Only)
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
JEM Research LLC
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Brain Matters Research, Inc.
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Individual Site Status
Withdrawn
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Individual Site Status
Withdrawn
Facility Name
Quest Research Institute
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Abington Neurological Associates
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Individual Site Status
Terminated
Facility Name
Kerwin Research Center, LLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Name
Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre
City
Heidelberg West
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Individual Site Status
Recruiting
Facility Name
Alfred Hospital; Department of Neurology
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Yokohama City Minato Red Cross Hospital
City
Kanagawa
ZIP/Postal Code
231-8682
Country
Japan
Individual Site Status
Recruiting
Facility Name
Koseikai Takeda Hospital
City
Kyoto
ZIP/Postal Code
600-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Utano National Hospital; Neurology
City
Kyoto
ZIP/Postal Code
616-8255
Country
Japan
Individual Site Status
Recruiting
Facility Name
Keio University Hospital; Neurology
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Tokyo Metropolitan Geriatric Hospital
City
Tokyo
ZIP/Postal Code
173-0015
Country
Japan
Individual Site Status
Recruiting
Facility Name
Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital
City
Tokyo
ZIP/Postal Code
190-8531
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osrodek Badan Klinicznych Euromedis
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Individual Site Status
Recruiting
Facility Name
NZOZ WCA
City
Wroc?aw
ZIP/Postal Code
53-659
Country
Poland
Individual Site Status
Recruiting
Facility Name
Hospital General De Catalunya; Servicio de Neurologia
City
Sant Cugat del Valles
State/Province
Barcelona
ZIP/Postal Code
8195
Country
Spain
Individual Site Status
Recruiting
Facility Name
Fundación ACE; Servicio de Neurología
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Clinic i Provincial; Servicio de Neurologia
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitario Dr. Peset; Servicio de Neurologia
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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).

Learn more about this trial

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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