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A Study of Gantenerumab in Participants With Mild Alzheimer Disease

Primary Purpose

Alzheimer's Disease

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Placebo

Gantenerumab

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinical diagnosis of probable mild Alzheimer disease (AD) based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria or major NCD based whether or not receiving AD approved medication
Cerebral spinal fluid (CSF) result consistent with the presence of amyloid pathology
Availability of a person ('caregiver') who in the investigator's judgment has frequent and sufficient contact with the participant, and is able to provide accurate information regarding the participant's cognitive and functional abilities
Fluency in the language of the tests used at the study site
Willingness and ability to complete all aspects of the study
Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eye glasses and hearing aids are permitted)
If currently receiving approved medications for AD, the dosing regimen must have been stable for 3 months prior to screening
Agreement not to participate in other research studies for the duration of this trial and its associated substudies

PART 2 - All participants who have been randomized and are actively participating in the study are eligible for Part 2

Exclusion Criteria:

Dementia or neurocognitive disorder (NCD) due to a condition other than AD, including, but not limited to, frontotemporal dementia, Parkinson disease, dementia with Lewy bodies, Huntington disease, or vascular dementia
History or presence of clinically evident vascular disease potentially affecting the brain that in the opinion of the investigator has the potential to affect cognitive function
History or presence of stroke within the past 2 years or documented history of transient ischemic attack within the last 12 months
History or presence of systemic autoimmune disorders potentially causing progressive neurologic disease with associated cognitive deficits
History of schizophrenia, schizoaffective disorder, or bipolar disorder
Alcohol and/or substance use disorder (according to the DSM-5) within the past 2 years (nicotine use is allowed)
History or presence of atrial fibrillation
Within the last 2 years, unstable or clinically significant cardiovascular disease (e.g., myocardial infarction, angina pectoris, cardiac failure New York Heart Association Class II or higher)
Uncontrolled hypertension
Chronic kidney disease
Impaired hepatic function

PET imaging substudy, in addition to above:

- Prior participation in other research study or clinical care within the last year such that the total radiation exposure would exceed the local or national annual limits

Part 2 Participants who have been discontinued from the study

Sites / Locations

Banner Sun Health Research Insitute
Territory Neurology and Research Institute
ATP Clinical Research, Inc
Pacific Research Network - PRN
California Neuroscience Research Medical Group, Inc
Meridien Research
Brain Matters Research, Inc.
Neuropsychiatric Research; Center of Southwest Florida
Miami Jewish Health Systems; Clinical Research
Accelerated Enrollment Solutions
University of South Florida
Alzheimer's Research and Treatment Center
Indiana University
Pennington Biomedical Research Center
Louisiana Research Associates
Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research
Millennium Psychiatric Associates, LLC
Alzheimer's Research Corporation
Ocean Rheumatology
Nathan Kline Institute
Richmond Behavioral Associates
Alzheimer's Memory Center
Richard H Weisler, MD
Central States Research
Abington Neurological Associates
Northeastern Pennsylvania Memory
Rhode Island Mood & Memory Research Institute
Neurology Clinic PC
Senior Adults Specialty Research
University of Utah, Center for Alzheimer's Care Imaging & Research
Instituto Neurologia Bs As
Royal Adelaide Hospital; Memory Trials Centre
The Queen Elizabeth Hospital; Neurology
Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre
Australian Alzheimer's Research Foundation
Cliniques Universitaires St-Luc
UZ Leuven Gasthuisberg
Shat Np Sveti Naum; 3Rd Clinic of Neurology
MBAL St. Marina; First Neurology Department
University of Calgary; Heritage Medical Research Clinic
True North Clinical Research-Halifax
True North Clinical Research
Jbn Medical Diagnostic Services Inc.
Parkwood Hospital; Geriatric Medicine
Kawartha Centre - Redefining Healthy Aging
Toronto Memory Program
Sunnybrook Health Sciences Centre
Recherches Neuro-Hippocame
NeuroSearch Developpements inc
Jewish General Hospital / McGill University
Centre Hospitalier Affilie Universitaire de Quebec - Hopital de L'Enfant Jesus
McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric
Alpha Recherche Clinique
Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken
Rigshospitalet, Hukommelsesklinikken
University of Eastern Finland
CRST Oy
Hopital Pellegrin; Cmrr Aquitaine
Hopital Pierre Wertheimer; Laboratoire De Neuro Psychologie
CHU de Limoges Hopital Dupuytren; Service de Medecine Geriatrique
CHU de la Timone - Hopital d Adultes; Service de Neurologie
CHU Rennes - hopital Hotel Dieu; Consultation Memoire - Gerontologie
Hopital Hautepierre; Centre dInvestigation Clinique
Hopital la Grave; Gerontopole - Centre de Recherche Clinique
ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic
PANAKEIA - Arzneimittelforschung Leipzig GmbH
Pharmakologisches Studienzentrum
Klinikum rechts der Isar der TU München; Klinikapotheke
Neurologische Praxis Dr. Andrej Pauls
Universitätsklinikum Ulm; Klinik für Neurologie
Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz
Semmelweis University; Department of Neurology
Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica - Dipartimento di Neuroscienze
Azienda Ospedaliera Universitaria Policlinico Tor Vergata; Neurologia
Umberto I Policlinico di Roma-Università di Roma La Sapienza
IRCCS "Centro S. Giovanni di Dio" Fatebenefratelli -UO Alzheimer
Irccs Multimedica Santa Maria; Unita' Di Neurologia
ASST DI MONZA; Neurologia
A.O. Universitaria Pisana; Neurologia
Medical Corporation Hakuyokai Kashiwado Hospital
National Hospital Organization Chiba-east Hospital; Neurology
Juntendo University Urayasu Hospital; Neurology
Fukuoka University Hospital; Neurology and Health Care
Maebashi Red Cross Hospital; Neurology
National Hospital Organization Hiroshima-Nishi Medical Center
Hyogo Brain and Heart Center at Himeji; Department of Aging Brain and Cognitive Disorders
Shonan Kamakura General Hospital; Neurology
Oita University Hospital; Neurology
Kurashiki Heisei Hospital; Neurology
Shizuoka City Shimizu Hospital; Neurology
Dong-A University Medical Center
Seoul National University Bundang Hospital; Neurology Department
Inha University Hospital; Neurology Department
Konkuk University Medical Center
Samsung Medical Center
Ewha Womans University Hospital (Seoul)
The Catholic University of Korea, Seoul St. Mary's Hospital
Asan Medical Center.
Ewha Womans University Mokdong Hospital; Dept of Neurology
Brain Research Center B.V
Erasmus Mc - Locatie Centrum; Dept of Neurology
Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia
Hospital de Santa Maria; Servico de Neurologia
State Autonomous Healthcare Institution "Republican Clinical Neurological Center
State autonomous institution of healthcare Inter-regional clinical and diagnostic center
Institution of RAMS (Mental Health Research Center of RAMS)
SBEI of HPI The 1st Moscow State Medical University n.a. I.M. Sechenov of MOH of RF
Saint Petersburg State Institution of Healthcare City Geriatric Medico-Social Center
City Clinical Hospital # 2 n.a. V.I. Razumovsky
Russian Medical Military Academy n.a. S.M.Kirov; Neurology Department
Hospital General Universitario de Elche; Servicio de Neurología
Fundació ACE
Policlínica Guipuzkoa; Servicio de Neurología
Hospital de Cruces; Servicio de Neurologia
Hospital del Mar; Servicio de Neurologia
Hospital Universitario 12 de Octubre; Servicio de Neurologia
Hospital Universitario Virgen Macarena; Servicio de Neurologia
Hospital Universitari i Politecnic La Fe
Skånes Universitetssjukhus Malmö, Minneskliniken
KAROLINSKA UNI HOSPITAL, HUDDINGE; Mottagning Kognitiv Forskning, M54
Felix Platter-Spital Medizin Geriatrie
CHUV Lausanne Memory clinique
Istanbul University Istanbul School of Medicine; Neurology
Dokuz Eylul University Medicine Faculty; Noroloji Departmani
Ondokuz Mayis University School of Medicine; Neurology
Sussex Partnership NHS Foundation Trust; Cognitive Treatment and Research unit
Glasgow Memory Clinic
Charing Cross Hospital; Dept of Neurosciences
Manchester Royal Infirmary
Royal Preston Hosptial
Memory Service North

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Part 1 (Double Blind treatment): Placebo

Part 1 (Double Blind treatment): Gantenerumab

Part 2 (Open-Label Extension [OLE] treatment): Placebo switched to Gantenerumab Up to 1200 mg

Part 2 (OLE treatment): Gantenerumab up to 1200 mg

Arm Description

Participants received matching placebo by subcutaneous (SC) injection every 4 weeks (Q4W) up to 100 weeks during Part 1 of the study.

Participants received 105 mg Gantenerumab by SC injection Q4W for 24 weeks and if eligible 225 mg SC injection Q4W from weeks 28-100 during Part 1 of the study.

Participants who had received Placebo in Part 1, received Gantenerumab at doses up to 1200 mg by SC injection Q4W for up to 2 years. Additionally, participants were given the option to continue receiving open-label gantenerumab treatment for 3 years.

Participants who had received Gantenerumab in Part 1, received treatment at doses up to 1200 mg by SC injection Q4W for up to 2 years. Additionally, participants were given the option to continue receiving open-label gantenerumab treatment for 3 years.

Outcomes

Primary Outcome Measures

Part 2: Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. SAE is any adverse event that is fatal or which requires or prolongs inpatient hospitalization or results in persistent or significant disability/incapacity or causes congenital anomaly/birth defect or results in a significant medical event in the investigator's judgment.

Part 2: Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs)

Participants were considered positive or negative for ADA based on their baseline and post-baseline sample results. The number and percentage of participants with confirmed positive ADA levels were determined for participants previously (in part 1) on Gantenerumab and Placebo. The prevalence of ADA at baseline was calculated as the percentage of participants with confirmed positive ADA levels at baseline relative to the total number of participants with a sample available at baseline. The incidence of treatment-emergent ADAs was determined as the percentage of participants with confirmed post-baseline positive ADAs relative to the total number of participants that had at least one post-baseline sample available for ADA analysis.

Part 2: Percentage of Participants With Adverse Events Leading to Discontinuation of Treatment

Percentage of participants with adverse events leading to discontinuation from treatment were reported.

Secondary Outcome Measures

Part 1: Percentage of Participants With AEs, SAEs

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. A serious adverse event is any adverse event that is fatal or which requires or prolongs inpatient hospitalization or results in persistent or significant disability/incapacity or causes congenital anomaly/birth defect or results in a significant medical event in the investigator's judgment.

Part 1: Percentage of Participants With Treatment Emergent ADAs

Part 1: Gantenerumab Plasma Concentration at Multiple Timepoints

Part 1: Percentage of Participants With Adverse Events Leading to Discontinuation of Treatment

Percentage of participants with adverse events leading to discontinuation from treatment were reported.

Part 2: Percent Change From Baseline in Hippocampal Volume at Week 104

Change from baseline in hippocampal right volume (HRV) and hippocampal left volume (HLV) were analyzed at Week 104 using magnetic resonance imaging.

Part 2: Percent Change From Baseline in Whole Brain Volume at Week 104

Change from baseline brain volume were analyzed at Week 104 using magnetic resonance imaging.

Part 2: Percent Change From Baseline in Cortical Thickness at Week 104

Change from baseline in cortical thickness were analyzed at Week 104 using magnetic resonance imaging.

Part 2: Ventricular Volume as Measured by MRI at Week 104

Ventricular volume were analyzed at Week 104 using magnetic resonance imaging.

Part 2: Gantenerumab Plasma Concentration at Multiple Timepoints

Part 2: Change From Baseline in Brain Amyloid Load at Week 156 in a Subset of Participants

Brain amyloid load over time was assessed using a Florbetapir [F18] injection, a positron emission tomography (PET) radioligand selective to amyloid. Analysis was conducted in a subset of participants who signed consent to participate in the PET substudy. Amyloid PET burden was measured in a composite region of interest (ROI) by using standardized uptake value ratio (SUVR) mapped to the centiloid scale. The composite region was composed of the following six bilateral regions: frontal lobe, parietal lobe, temporal lobe, posterior cingulate cortex, anterior cingulate cortex. The reference region used to normalize the composite region was the cerebellar cortex. SUVR is ratio of tracer uptake in each of cingulate, frontal, parietal and temporal cortexes relative to cerebellum. The centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scans.

Full Information

NCT ID

NCT02051608

First Posted

January 30, 2014

Last Updated

February 8, 2023

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT02051608

Brief Title

A Study of Gantenerumab in Participants With Mild Alzheimer Disease

Official Title

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Study of Gantenerumab in Patients With Mild Alzheimer's Disease; Part II: Open-Label Extension For Participating Patients

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

March 27, 2014 (Actual)

Primary Completion Date

April 16, 2021 (Actual)

Study Completion Date

April 16, 2021 (Actual)

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

5. Study Description

Brief Summary

Part 1 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of gantenerumab in participants with mild Alzheimer disease. Participants will be randomized to receive either gantenerumab subcutaneously every 4 weeks or placebo subcutaneously every 4 weeks. Approved Alzheimer medication is allowed if on stable dose for 3 months prior to screening. Part 2 is an open-label extension (OLE). A positron emission tomography (PET) imaging substudy will be conducted within the main study. Eligible participants who provide separate informed consent will undergo PET imaging scans using the radioligand florbetapir as a pharmacodynamic measure of changes in brain amyloid load over time.

6. Conditions and Keywords

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

Alzheimer's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

389 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part 1 (Double Blind treatment): Placebo

Arm Type

Placebo Comparator

Arm Description

Participants received matching placebo by subcutaneous (SC) injection every 4 weeks (Q4W) up to 100 weeks during Part 1 of the study.

Arm Title

Part 1 (Double Blind treatment): Gantenerumab

Arm Type

Experimental

Arm Description

Participants received 105 mg Gantenerumab by SC injection Q4W for 24 weeks and if eligible 225 mg SC injection Q4W from weeks 28-100 during Part 1 of the study.

Arm Title

Part 2 (Open-Label Extension [OLE] treatment): Placebo switched to Gantenerumab Up to 1200 mg

Arm Type

Placebo Comparator

Arm Description

Arm Title

Part 2 (OLE treatment): Gantenerumab up to 1200 mg

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Participants received Placebo SC injection Q4W.

Intervention Type

Drug

Intervention Name(s)

Gantenerumab

Intervention Description

Participants received Gantenerumab at 105 mg , 225 mg, or at doses up to 1200 mg SC injection Q4W.

Primary Outcome Measure Information:

Title

Part 2: Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)

Description

Time Frame

First dose up to 4 weeks after the last dose of study drug (up to 249 weeks)

Title

Part 2: Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs)

Description

Time Frame

First dose up to last dose (Baseline up to until maximum 5 years)

Title

Part 2: Percentage of Participants With Adverse Events Leading to Discontinuation of Treatment

Description

Percentage of participants with adverse events leading to discontinuation from treatment were reported.

Time Frame

First dose up to 4 weeks after the last dose in OLE (Up to approximately 249 weeks)

Secondary Outcome Measure Information:

Title

Part 1: Percentage of Participants With AEs, SAEs

Description

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. A serious adverse event is any adverse event that is fatal or which requires or prolongs inpatient hospitalization or results in persistent or significant disability/incapacity or causes congenital anomaly/birth defect or results in a significant medical event in the investigator's judgment.

Time Frame

First dose up to last dose (Up to approximately 152 weeks)

Title

Part 1: Percentage of Participants With Treatment Emergent ADAs

Description

Time Frame

First dose up to last dose (Up to approximately 152 weeks)

Title

Part 1: Gantenerumab Plasma Concentration at Multiple Timepoints

Time Frame

Pre-dose: Weeks 4, 8, 12, 24, 48, 72 and Post dose: Day 4

Title

Part 1: Percentage of Participants With Adverse Events Leading to Discontinuation of Treatment

Description

Percentage of participants with adverse events leading to discontinuation from treatment were reported.

Time Frame

First dose up to last dose (Up to approximately 152 weeks)

Title

Part 2: Percent Change From Baseline in Hippocampal Volume at Week 104

Description

Change from baseline in hippocampal right volume (HRV) and hippocampal left volume (HLV) were analyzed at Week 104 using magnetic resonance imaging.

Time Frame

Baseline (Part 1 screening), Week 104

Title

Part 2: Percent Change From Baseline in Whole Brain Volume at Week 104

Description

Change from baseline brain volume were analyzed at Week 104 using magnetic resonance imaging.

Time Frame

Baseline (Part 1 screening), Week 104

Title

Part 2: Percent Change From Baseline in Cortical Thickness at Week 104

Description

Change from baseline in cortical thickness were analyzed at Week 104 using magnetic resonance imaging.

Time Frame

Baseline (Part 1 screening), Week 104

Title

Part 2: Ventricular Volume as Measured by MRI at Week 104

Description

Ventricular volume were analyzed at Week 104 using magnetic resonance imaging.

Time Frame

Part 2: Week 104

Title

Part 2: Gantenerumab Plasma Concentration at Multiple Timepoints

Time Frame

Pre-dose: Weeks 104, 116, 156, 208; Post-dose: Weeks 53, 101

Title

Part 2: Change From Baseline in Brain Amyloid Load at Week 156 in a Subset of Participants

Description

Time Frame

Baseline, Week 156

Other Pre-specified Outcome Measures:

Title

Part 1: Mean Change From Baseline in Alzheimer's Disease Activity Scale-Cognitive Subscale 13 (ADAS-Cog13) Scores at Week 104

Time Frame

Baseline, Week 104

Title

Part 1: Mean Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Scores at Week 104

Time Frame

Baseline, Week 104

Title

Part 1: Percentage Change From Baseline in Total Tau (T-tau) in CSF at Week 104

Time Frame

Baseline, Week 104

Title

Part 1: Percentage Change From Baseline in Abeta 1-42 Levels in CSF at Week 104

Time Frame

Baseline, Week 104

Title

Part 1: Percentage Change From Baseline in Phosphorylated Tau [P-tau] in CSF at Week 104

Time Frame

Baseline, Week 104

Title

Part 1: Percent Change From Baseline in Hippocampal Volume at Week 104

Time Frame

Baseline, Week 104

Title

Part 1: Percent Change From Baseline in Whole Brain Volume at Week 104

Time Frame

Baseline, Week 104

Title

Part 1: Percent Change From Baseline in Cortical Thickness at Week 104

Time Frame

Baseline, Week 104

Title

Part 1: Ventricular Volume as Measured by MRI at Week 104

Time Frame

Baseline, Week 104

Title

Part 1: Change From Baseline in Clinical Dementia Rating Global Score (CDR-GS) at Week 104

Time Frame

Baseline, Week 104

Title

Part 1: Change From Baseline in CDR Sum of Boxes (SB) at Week 104

Time Frame

Baseline, Week 104

Title

Part 1: Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Week 104

Time Frame

Baseline, Week 104

Title

Part 1: Change From Baseline in NPI Domain Score at Week 104

Time Frame

Baseline, Week 104

Title

Part 1: Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Week 104

Time Frame

Baseline, Week 104

Title

Part 1: Change From Baseline in Alzheimer's Dementia (QoL-AD) Global Score at Week 104

Time Frame

Baseline, Week 104

Title

Part 1: Change From Baseline in Symptom Guide Facilitated (GAS) at Week 104

Time Frame

Baseline, Week 104

Title

Part 1: Change From Baseline in Dependence Scale (DS) at Week 104

Time Frame

Baseline, Week 104

Title

Part 1: Change From Baseline in Resource Utilization Dementia-Lite (RUD - Lite) Scale at Week 104

Time Frame

Baseline, Week 104

Title

Part 1: Change From Baseline in Zarit Caregiver Interview for Alzheimer's Disease (ZCI-AD) at Week 104

Time Frame

Baseline, Week 104

Title

Part 1: Time to Clinical Decline

Time Frame

Baseline up to Week 104

Title

Part 1: Change From Baseline in Clinical Composite Score (Prespecified Items From The ADAS-Cog, MMSE, and CDR) at Week 104

Time Frame

Baseline, Week 104

Title

Part 1: Percentage of Participants With ADAS-Cog Response

Time Frame

Baseline up to Week 152

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical diagnosis of probable mild Alzheimer disease (AD) based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria or major NCD based whether or not receiving AD approved medication Cerebral spinal fluid (CSF) result consistent with the presence of amyloid pathology Availability of a person ('caregiver') who in the investigator's judgment has frequent and sufficient contact with the participant, and is able to provide accurate information regarding the participant's cognitive and functional abilities Fluency in the language of the tests used at the study site Willingness and ability to complete all aspects of the study Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eye glasses and hearing aids are permitted) If currently receiving approved medications for AD, the dosing regimen must have been stable for 3 months prior to screening Agreement not to participate in other research studies for the duration of this trial and its associated substudies PART 2 - All participants who have been randomized and are actively participating in the study are eligible for Part 2 Exclusion Criteria: Dementia or neurocognitive disorder (NCD) due to a condition other than AD, including, but not limited to, frontotemporal dementia, Parkinson disease, dementia with Lewy bodies, Huntington disease, or vascular dementia History or presence of clinically evident vascular disease potentially affecting the brain that in the opinion of the investigator has the potential to affect cognitive function History or presence of stroke within the past 2 years or documented history of transient ischemic attack within the last 12 months History or presence of systemic autoimmune disorders potentially causing progressive neurologic disease with associated cognitive deficits History of schizophrenia, schizoaffective disorder, or bipolar disorder Alcohol and/or substance use disorder (according to the DSM-5) within the past 2 years (nicotine use is allowed) History or presence of atrial fibrillation Within the last 2 years, unstable or clinically significant cardiovascular disease (e.g., myocardial infarction, angina pectoris, cardiac failure New York Heart Association Class II or higher) Uncontrolled hypertension Chronic kidney disease Impaired hepatic function PET imaging substudy, in addition to above: - Prior participation in other research study or clinical care within the last year such that the total radiation exposure would exceed the local or national annual limits Part 2 Participants who have been discontinued from the study

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

Banner Sun Health Research Insitute

City

Sun City

State/Province

Arizona

ZIP/Postal Code

85351

Country

United States

Facility Name

Territory Neurology and Research Institute

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85704

Country

United States

Facility Name

ATP Clinical Research, Inc

City

Costa Mesa

State/Province

California

ZIP/Postal Code

92626

Country

United States

Facility Name

Pacific Research Network - PRN

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

California Neuroscience Research Medical Group, Inc

City

Sherman Oaks

State/Province

California

ZIP/Postal Code

91403

Country

United States

Facility Name

Meridien Research

City

Brooksville

State/Province

Florida

ZIP/Postal Code

34601

Country

United States

Facility Name

Brain Matters Research, Inc.

City

Delray Beach

State/Province

Florida

ZIP/Postal Code

33445

Country

United States

Facility Name

Neuropsychiatric Research; Center of Southwest Florida

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33912

Country

United States

Facility Name

Miami Jewish Health Systems; Clinical Research

City

Miami

State/Province

Florida

ZIP/Postal Code

33137

Country

United States

Facility Name

Accelerated Enrollment Solutions

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

University of South Florida

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613-4706

Country

United States

Facility Name

Alzheimer's Research and Treatment Center

City

Wellington

State/Province

Florida

ZIP/Postal Code

33414

Country

United States

Facility Name

Indiana University

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Pennington Biomedical Research Center

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808

Country

United States

Facility Name

Louisiana Research Associates

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70114

Country

United States

Facility Name

Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49008

Country

United States

Facility Name

Millennium Psychiatric Associates, LLC

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63132

Country

United States

Facility Name

Alzheimer's Research Corporation

City

Manchester

State/Province

New Jersey

ZIP/Postal Code

08759

Country

United States

Facility Name

Ocean Rheumatology

City

Toms River

State/Province

New Jersey

ZIP/Postal Code

08775

Country

United States

Facility Name

Nathan Kline Institute

City

Orangeburg

State/Province

New York

ZIP/Postal Code

10962

Country

United States

Facility Name

Richmond Behavioral Associates

City

Staten Island

State/Province

New York

ZIP/Postal Code

10312

Country

United States

Facility Name

Alzheimer's Memory Center

City

Matthews

State/Province

North Carolina

ZIP/Postal Code

28105

Country

United States

Facility Name

Richard H Weisler, MD

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27609

Country

United States

Facility Name

Central States Research

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74136

Country

United States

Facility Name

Abington Neurological Associates

City

Abington

State/Province

Pennsylvania

ZIP/Postal Code

19001

Country

United States

Facility Name

Northeastern Pennsylvania Memory

City

Plains

State/Province

Pennsylvania

ZIP/Postal Code

18705

Country

United States

Facility Name

Rhode Island Mood & Memory Research Institute

City

East Providence

State/Province

Rhode Island

ZIP/Postal Code

02914

Country

United States

Facility Name

Neurology Clinic PC

City

Cordova

State/Province

Tennessee

ZIP/Postal Code

38018

Country

United States

Facility Name

Senior Adults Specialty Research

City

Austin

State/Province

Texas

ZIP/Postal Code

78757

Country

United States

Facility Name

University of Utah, Center for Alzheimer's Care Imaging & Research

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84108

Country

United States

Facility Name

Instituto Neurologia Bs As

City

Ciudad Autonoma Buenos Aires

ZIP/Postal Code

C1426ANZ

Country

Argentina

Facility Name

Royal Adelaide Hospital; Memory Trials Centre

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

The Queen Elizabeth Hospital; Neurology

City

Woodville

State/Province

South Australia

ZIP/Postal Code

5011

Country

Australia

Facility Name

Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre

City

Heidelberg West

State/Province

Victoria

ZIP/Postal Code

3081

Country

Australia

Facility Name

Australian Alzheimer's Research Foundation

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

Cliniques Universitaires St-Luc

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

UZ Leuven Gasthuisberg

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Shat Np Sveti Naum; 3Rd Clinic of Neurology

City

Sofia

ZIP/Postal Code

1113

Country

Bulgaria

Facility Name

MBAL St. Marina; First Neurology Department

City

Varna

ZIP/Postal Code

9010

Country

Bulgaria

Facility Name

University of Calgary; Heritage Medical Research Clinic

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4Z6

Country

Canada

Facility Name

True North Clinical Research-Halifax

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3S 1N2

Country

Canada

Facility Name

True North Clinical Research

City

New Minas

State/Province

Nova Scotia

ZIP/Postal Code

B4N 3R7

Country

Canada

Facility Name

Jbn Medical Diagnostic Services Inc.

City

Burlington

State/Province

Ontario

ZIP/Postal Code

L7M 4Y1

Country

Canada

Facility Name

Parkwood Hospital; Geriatric Medicine

City

London

State/Province

Ontario

ZIP/Postal Code

N6C 5J1

Country

Canada

Facility Name

Kawartha Centre - Redefining Healthy Aging

City

Peterborough

State/Province

Ontario

ZIP/Postal Code

K9H 2P4

Country

Canada

Facility Name

Toronto Memory Program

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M3B 2S7

Country

Canada

Facility Name

Sunnybrook Health Sciences Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

Recherches Neuro-Hippocame

City

Gatineau

State/Province

Quebec

ZIP/Postal Code

J8T 8J1

Country

Canada

Facility Name

NeuroSearch Developpements inc

City

Greenfield Park

State/Province

Quebec

ZIP/Postal Code

J4V 2J2

Country

Canada

Facility Name

Jewish General Hospital / McGill University

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Facility Name

Centre Hospitalier Affilie Universitaire de Quebec - Hopital de L'Enfant Jesus

City

Quebec City

State/Province

Quebec

ZIP/Postal Code

G1J 1Z4

Country

Canada

Facility Name

McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric

City

Verdun

State/Province

Quebec

ZIP/Postal Code

H4H 1R3

Country

Canada

Facility Name

Alpha Recherche Clinique

City

Quebec

ZIP/Postal Code

G3K 2P8

Country

Canada

Facility Name

Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken

City

Aarhus N

ZIP/Postal Code

8200

Country

Denmark

Facility Name

Rigshospitalet, Hukommelsesklinikken

City

Koebenhavn Oe

ZIP/Postal Code

2100

Country

Denmark

Facility Name

University of Eastern Finland

City

Kuopio

ZIP/Postal Code

70210

Country

Finland

Facility Name

CRST Oy

City

Turku

ZIP/Postal Code

20520

Country

Finland

Facility Name

Hopital Pellegrin; Cmrr Aquitaine

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Facility Name

Hopital Pierre Wertheimer; Laboratoire De Neuro Psychologie

City

Bron

ZIP/Postal Code

69677

Country

France

Facility Name

CHU de Limoges Hopital Dupuytren; Service de Medecine Geriatrique

City

Limoges

ZIP/Postal Code

87042

Country

France

Facility Name

CHU de la Timone - Hopital d Adultes; Service de Neurologie

City

Marseille

ZIP/Postal Code

13005

Country

France

Facility Name

CHU Rennes - hopital Hotel Dieu; Consultation Memoire - Gerontologie

City

Rennes

ZIP/Postal Code

35064

Country

France

Facility Name

Hopital Hautepierre; Centre dInvestigation Clinique

City

Strasbourg

ZIP/Postal Code

67098

Country

France

Facility Name

Hopital la Grave; Gerontopole - Centre de Recherche Clinique

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

PANAKEIA - Arzneimittelforschung Leipzig GmbH

City

Leipzig

ZIP/Postal Code

04275

Country

Germany

Facility Name

Pharmakologisches Studienzentrum

City

Mittweida

ZIP/Postal Code

09648

Country

Germany

Facility Name

Klinikum rechts der Isar der TU München; Klinikapotheke

City

Muenchen

ZIP/Postal Code

81675

Country

Germany

Facility Name

Neurologische Praxis Dr. Andrej Pauls

City

München

ZIP/Postal Code

80331

Country

Germany

Facility Name

Universitätsklinikum Ulm; Klinik für Neurologie

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz

City

Westerstede

ZIP/Postal Code

26655

Country

Germany

Facility Name

Semmelweis University; Department of Neurology

City

Budapest

ZIP/Postal Code

1083

Country

Hungary

Facility Name

Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica - Dipartimento di Neuroscienze

City

Modena

State/Province

Emilia-Romagna

ZIP/Postal Code

41126

Country

Italy

Facility Name

Azienda Ospedaliera Universitaria Policlinico Tor Vergata; Neurologia

City

Roma

State/Province

Lazio

ZIP/Postal Code

00133

Country

Italy

Facility Name

Umberto I Policlinico di Roma-Università di Roma La Sapienza

City

Roma

State/Province

Lazio

ZIP/Postal Code

00185

Country

Italy

Facility Name

IRCCS "Centro S. Giovanni di Dio" Fatebenefratelli -UO Alzheimer

City

Brescia

State/Province

Lombardia

ZIP/Postal Code

25125

Country

Italy

Facility Name

Irccs Multimedica Santa Maria; Unita' Di Neurologia

City

Castellanza

State/Province

Lombardia

ZIP/Postal Code

21053

Country

Italy

Facility Name

ASST DI MONZA; Neurologia

City

Monza

State/Province

Lombardia

ZIP/Postal Code

20900

Country

Italy

Facility Name

A.O. Universitaria Pisana; Neurologia

City

Pisa

State/Province

Toscana

ZIP/Postal Code

56126

Country

Italy

Facility Name

Medical Corporation Hakuyokai Kashiwado Hospital

City

Chiba

ZIP/Postal Code

260-8656

Country

Japan

Facility Name

National Hospital Organization Chiba-east Hospital; Neurology

City

Chiba

ZIP/Postal Code

260-8712

Country

Japan

Facility Name

Juntendo University Urayasu Hospital; Neurology

City

Chiba

ZIP/Postal Code

279-0021

Country

Japan

Facility Name

Fukuoka University Hospital; Neurology and Health Care

City

Fukuoka

ZIP/Postal Code

814-0180

Country

Japan

Facility Name

Maebashi Red Cross Hospital; Neurology

City

Gunma

ZIP/Postal Code

371-0014

Country

Japan

Facility Name

National Hospital Organization Hiroshima-Nishi Medical Center

City

Hiroshima

ZIP/Postal Code

739-0696

Country

Japan

Facility Name

Hyogo Brain and Heart Center at Himeji; Department of Aging Brain and Cognitive Disorders

City

Hyogo

ZIP/Postal Code

670-0981

Country

Japan

Facility Name

Shonan Kamakura General Hospital; Neurology

City

Kanagawa

ZIP/Postal Code

247-8533

Country

Japan

Facility Name

Oita University Hospital; Neurology

City

Oita

ZIP/Postal Code

879-5593

Country

Japan

Facility Name

Kurashiki Heisei Hospital; Neurology

City

Okayama

ZIP/Postal Code

710-0826

Country

Japan

Facility Name

Shizuoka City Shimizu Hospital; Neurology

City

Shizuoka

ZIP/Postal Code

424-0911

Country

Japan

Facility Name

Dong-A University Medical Center

City

Busan

ZIP/Postal Code

602-715

Country

Korea, Republic of

Facility Name

Seoul National University Bundang Hospital; Neurology Department

City

Gyeonggi-do

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

Inha University Hospital; Neurology Department

City

Incheon

ZIP/Postal Code

22332

Country

Korea, Republic of

Facility Name

Konkuk University Medical Center

City

Seoul

ZIP/Postal Code

05030

Country

Korea, Republic of

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Ewha Womans University Hospital (Seoul)

City

Seoul

ZIP/Postal Code

07804

Country

Korea, Republic of

Facility Name

The Catholic University of Korea, Seoul St. Mary's Hospital

City

Seoul

ZIP/Postal Code

137-701

Country

Korea, Republic of

Facility Name

Asan Medical Center.

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Facility Name

Ewha Womans University Mokdong Hospital; Dept of Neurology

City

Seoul

ZIP/Postal Code

158-710

Country

Korea, Republic of

Facility Name

Brain Research Center B.V

City

Amsterdam

ZIP/Postal Code

1081 GN

Country

Netherlands

Facility Name

Erasmus Mc - Locatie Centrum; Dept of Neurology

City

Rotterdam

ZIP/Postal Code

3015 GD

Country

Netherlands

Facility Name

Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia

City

Amadora

ZIP/Postal Code

2720-276

Country

Portugal

Facility Name

Hospital de Santa Maria; Servico de Neurologia

City

Lisboa

ZIP/Postal Code

1649-035

Country

Portugal

Facility Name

State Autonomous Healthcare Institution "Republican Clinical Neurological Center

City

Kazan

ZIP/Postal Code

420021

Country

Russian Federation

Facility Name

State autonomous institution of healthcare Inter-regional clinical and diagnostic center

City

Kazan

ZIP/Postal Code

420101

Country

Russian Federation

Facility Name

Institution of RAMS (Mental Health Research Center of RAMS)

City

Moscow

ZIP/Postal Code

115522

Country

Russian Federation

Facility Name

SBEI of HPI The 1st Moscow State Medical University n.a. I.M. Sechenov of MOH of RF

City

Moscow

ZIP/Postal Code

119021

Country

Russian Federation

Facility Name

Saint Petersburg State Institution of Healthcare City Geriatric Medico-Social Center

City

Saint Petersburg

ZIP/Postal Code

190103

Country

Russian Federation

Facility Name

City Clinical Hospital # 2 n.a. V.I. Razumovsky

City

Saratov

ZIP/Postal Code

410028

Country

Russian Federation

Facility Name

Russian Medical Military Academy n.a. S.M.Kirov; Neurology Department

City

St. Petersburg

ZIP/Postal Code

194044

Country

Russian Federation

Facility Name

Hospital General Universitario de Elche; Servicio de Neurología

City

Elche

State/Province

Alicante

ZIP/Postal Code

03203

Country

Spain

Facility Name

Fundació ACE

City

BArcelon

State/Province

Barcelona

ZIP/Postal Code

08034

Country

Spain

Facility Name

Policlínica Guipuzkoa; Servicio de Neurología

City

Donosti-San Sebastián

State/Province

Guipuzcoa

ZIP/Postal Code

20014

Country

Spain

Facility Name

Hospital de Cruces; Servicio de Neurologia

City

Barakaldo

State/Province

Vizcaya

ZIP/Postal Code

48903

Country

Spain

Facility Name

Hospital del Mar; Servicio de Neurologia

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

Hospital Universitario 12 de Octubre; Servicio de Neurologia

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Hospital Universitario Virgen Macarena; Servicio de Neurologia

City

Sevilla

ZIP/Postal Code

41009

Country

Spain

Facility Name

Hospital Universitari i Politecnic La Fe

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Skånes Universitetssjukhus Malmö, Minneskliniken

City

Malmö

ZIP/Postal Code

211 46

Country

Sweden

Facility Name

KAROLINSKA UNI HOSPITAL, HUDDINGE; Mottagning Kognitiv Forskning, M54

City

Stockholm

ZIP/Postal Code

141 86

Country

Sweden

Facility Name

Felix Platter-Spital Medizin Geriatrie

City

Basel

ZIP/Postal Code

4002

Country

Switzerland

Facility Name

CHUV Lausanne Memory clinique

City

Lausanne

ZIP/Postal Code

1011

Country

Switzerland

Facility Name

Istanbul University Istanbul School of Medicine; Neurology

City

Istanbul

ZIP/Postal Code

34093

Country

Turkey

Facility Name

Dokuz Eylul University Medicine Faculty; Noroloji Departmani

City

Izmir

ZIP/Postal Code

35340

Country

Turkey

Facility Name

Ondokuz Mayis University School of Medicine; Neurology

City

Samsun

ZIP/Postal Code

55139

Country

Turkey

Facility Name

Sussex Partnership NHS Foundation Trust; Cognitive Treatment and Research unit

City

Crowborough

ZIP/Postal Code

TN6 1HB

Country

United Kingdom

Facility Name

Glasgow Memory Clinic

City

Glasgow

ZIP/Postal Code

G20 0XA

Country

United Kingdom

Facility Name

Charing Cross Hospital; Dept of Neurosciences

City

London

ZIP/Postal Code

W6 8RF

Country

United Kingdom

Facility Name

Manchester Royal Infirmary

City

Manchester

ZIP/Postal Code

M13 9WL

Country

United Kingdom

Facility Name

Royal Preston Hosptial

City

Preston

ZIP/Postal Code

PR2 9HT

Country

United Kingdom

Facility Name

Memory Service North

City

Sheffield

ZIP/Postal Code

S35 8QS

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

31831056

Citation

Klein G, Delmar P, Voyle N, Rehal S, Hofmann C, Abi-Saab D, Andjelkovic M, Ristic S, Wang G, Bateman R, Kerchner GA, Baudler M, Fontoura P, Doody R. Gantenerumab reduces amyloid-beta plaques in patients with prodromal to moderate Alzheimer's disease: a PET substudy interim analysis. Alzheimers Res Ther. 2019 Dec 12;11(1):101. doi: 10.1186/s13195-019-0559-z.

Results Reference

derived

Learn more about this trial

A Study of Gantenerumab in Participants With Mild Alzheimer Disease

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