A Study of Gantenerumab in Participants With Prodromal Alzheimer's Disease (Scarlet Road)

• ClinicalTrials.gov Identifier: NCT01224106
• Recruitment Status: Completed
• First Posted: October 19, 2010
• Results First Posted: December 13, 2021
• Last Update Posted: December 13, 2021
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Study Description

Brief Summary:

This multi-center, randomized, double-blind, placebo-controlled parallel-group study will evaluate the effect of gantenerumab (RO4909832) on cognition and functioning and the safety and pharmacokinetics in participants with prodromal Alzheimer's Disease. Participants will be randomized to receive subcutaneous (SC) injections of either gantenerumab or placebo. Participants who consent to be part of the sub study will undergo positron emission tomography (PET) scanning to assess brain amyloid. The anticipated time on study treatment is 104 weeks in Part 1, with an option for an additional up to 2 years of treatment in Part 2, followed by an open-label extension (Part 3) until July 2020.

The dosing for Parts 1 and 2 was stopped after a planned futility interim analysis showed a low probability of meeting the primary outcome measure with the doses studied. The study has converted to open-label to investigate higher gantenerumab doses.

Condition or disease	Intervention/treatment	Phase
Alzheimer's Disease	Drug: Gantenerumab; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 799 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Two Year Study to Evaluate the Effect of Subcutaneous RO4909832 on Cognition and Function in Prodromal Alzheimer's Disease With Option for up to an Additional Two Years of Treatment and an Open-Label Extension With Active Study Treatment
• Actual Study Start Date: November 30, 2010
• Actual Primary Completion Date: September 10, 2020
• Actual Study Completion Date: September 10, 2020

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo (Parts 1 and 2); Participants with Alzheimer's disease received Placebo by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2.	Drug: Placebo; Participants received Placebo SC injection Q4W.
Experimental: Gantenerumab 105 mg (Parts 1 and 2); Participants with Alzheimer's disease received Gantenerumab 105 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2.	Drug: Gantenerumab; Participants received Gantenerumab at 105 mg , 225 mg, or at doses up to 1200 mg SC injection Q4W.
Experimental: Gantenerumab 225 mg (Parts 1 and 2); Participants with Alzheimer's disease received Gantenerumab 225 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2.	Drug: Gantenerumab; Participants received Gantenerumab at 105 mg , 225 mg, or at doses up to 1200 mg SC injection Q4W.
Placebo Comparator: Placebo (Parts 1 and 2) switched to Gantenerumab Up to 1200mg (Part 3 Open-Label Extension [OLE]); Participants with Alzheimer's disease who had received Placebo by SC injection in Part 1 or Part 2, now received Gantenerumab at doses up to 1200 mg by SC injection every 4 weeks (Q4W) for up to 5 additional years.	Drug: Gantenerumab; Participants received Gantenerumab at 105 mg , 225 mg, or at doses up to 1200 mg SC injection Q4W.
Experimental: Gantenerumab Up to 1200 mg (Part 3 Open-Label Extension [OLE]); Participants with Alzheimer's disease who had received Gantenerumab by SC injection in Part 1 or Part 2, now received Gantenerumab at doses up to 1200 mg by SC injection every 4 weeks (Q4W) for up to 5 additional years.	Drug: Gantenerumab; Participants received Gantenerumab at 105 mg , 225 mg, or at doses up to 1200 mg SC injection Q4W.

Outcome Measures

Primary Outcome Measures :

1. Mean Change From Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Total Score at Week 104 (Double-Blind Treatment Phase) [ Time Frame: Baseline, Week 104 ]
   The CDR (Clinical Dementia Rating) is obtained through semi-structured interviews of participants and informants, and cognitive functioning is rated in six domains of functioning: memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated on a five-point scale of functioning as follows: 0, no impairment; 0.5, questionable impairment; 1, mild impairment; 2, moderate impairment; and 3, severe impairment. The CDR-SOB (Clinical Dementia Rating-Sum of Boxes) is based on summing each of the domain box scores with total scores ranging from 0-18, where lower total scores represent better outcomes and higher total scores represent worse outcomes.
2. Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) (OLE Phase) [ Time Frame: Baseline up until a maximum of 5 years ]
   An Adverse Event 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. Preexisting conditions which worsen during a study are also considered as adverse events.

Secondary Outcome Measures :

1. Mean Change From Baseline in Alzheimer Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog-11) Scores at Week 104 (Double-Blind Treatment Phase) [ Time Frame: Baseline, Week 104 ]
   The ADAS-Cog-11 assesses multiple cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Most of these are assessed by tests although some are rated by the clinician on a 5-point scale. The score range for ADAS-Cog-11 is from 0 to 70 with higher scores representing severe dysfunction.
2. Time to Onset of Dementia at Week 104 (Double-Blind Treatment Phase) [ Time Frame: Baseline, Week 104 ]
   Time to Onset of Dementia was defined as the time interval between the first treatment date and the date that participant is assessed as having Alzheimer-type dementia by investigators.
3. Mean Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Composite Score at Week 104 (Double-Blind Treatment Phase) [ Time Frame: Baseline, Week 104 ]
   The Cambridge Neuropsychological Test Automated Battery (CANTAB) ® is a cognitive test battery that incorporates a variety of executive and memory tasks in order to assess neuropsychological function. The end outcome as reported below, is a Z-Composite Score. The score range of the Z-Composite Score is from (-) infinity to (+) infinity with a score of zero representing the population mean, lower (negative) scores representing poorer cognitive outcomes and higher (positive) scores representing better cognitive outcomes.
4. Mean Change From Baseline in Free and Cued Selective Reminding Test (FCSRT) Score at Week 104 (Double-Blind Treatment Phase) [ Time Frame: Baseline, Week 104 ]
   FCSRT assesses verbal episodic memory. Performances in free recalls, cued recalls and in a recognition task were analyzed, as the process of encoding is controlled. Participants were asked to remember a list of 16 words. Three tasks of free and cued recalls, as well as 1 recognition task and one delayed recall give the scores. Total recall was obtained by the addition of cued recalls to free recalls. Maximum score is 48 for immediate: 16 words multiplied by (*) 3 corresponding to immediate free recall + immediate cued recall + immediate recognition test. Maximum score is 64 (better score) when delayed recall: 16 words*4. The minimum score is 0 (worse).
5. Mean Change From Baseline in Functional Activities Questionnaire (FAQ) Score at Week 104 (Double-Blind Treatment Phase) [ Time Frame: Baseline, Week 104 ]
   Participants completed the FAQ for physical function. Overall scores ranged from 0 (independent) to 30 (dependent) where lower scores represented an improvement in physical function.
6. Mean Change From Baseline in CDR-Global Score at Week 104 (Double-Blind Treatment Phase) [ Time Frame: Baseline, Week 104 ]
   The CDR-GS represents a semi-structured interview which rates impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care) on a 5-point scale in which CDR 0 = no dementia and CDR 0.5, 1, 2 or 3 = questionable, mild, moderate or severe dementia respectively. The range in scores for the CDR-GS is from 0 to 3 and a high score on the CDR-GS would indicate a high disease severity.
7. Mean Change From Baseline in Neuropsychiatric Inventory (NPI) Questionnaire Score at Week 104 (Double-Blind Treatment Phase) [ Time Frame: Baseline, Week 104 ]
   The NPI is a retrospective (to 1 month) caregiver-informant interview assessing frequency and severity of 12 neuropsychiatric symptom domains. The NPI score is based on the sum of the severity ratings (0=absent, 1=mild, 3=severe). The 12 symptom domains include delusions, hallucinations, agitation/aggression, dysphoria/depression, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviors, nighttime behavioral disturbances, and appetite/eating abnormalities. The NPI severity score is based on severity ratings (0=absent, 1=mild to 3=severe).
8. Percentage Change From Baseline in Cerebrospinal Fluid Biomarkers (Phosphorylated-tau [P-tau], Amyloid Beta 1-42 [Abeta 1-42], Total Tau [T-tau]) at Week 104 (Double-Blind Treatment Phase) [ Time Frame: Baseline, Week 104 ]
   CSF biomarker phospho-tau (p-tau) is an indicator of neuronal injury and neurodegeneration. An elevation in levels of tau, as well as specific p-tau species, is thought to be a marker for progressive cellular degeneration in AD.
9. Percentage Change From Baseline in Hippocampal Volume at Week 104 (Double-Blind Treatment Phase) [ Time Frame: Baseline, Week 104 ]
   Change from baseline in hippocampal right volume (HRV) and hippocampal left volume (HLV) were analysed at Week 104 using magnetic resonance imaging.
10. Percentage Change From Baseline in Cortical Composite Sustained Uptake Volume Ratio (SUVr) in Different Brain Regions at Week 156 (Double-Blind Treatment Phase) [ Time Frame: Baseline, Week 156 ]
    The different regions of the brain that were analyzed included cerebellum gray, whole cerebellum, composite white matter, subcortical white matter, pons and composite reference.
11. Gantenerumab Plasma Concentrations at Different Time Points (Double-Blind Treatment Phase) [ Time Frame: Pre-Dose: Weeks 8, 20, 44, 68 and 100; Post-Dose: Weeks 1, 53 and 101 ]
    The PK analyses includes tabulation of plasma concentration data and summarisation of plasma concentrations by visits with participants grouped according to treatment received. Descriptive summary statistics for the Arithmetic Mean and Standard Deviation are presented below.
12. Mean Change From Baseline in Mini Mental State Exam (MMSE) Score at Week 104 (Double-Blind Treatment Phase) [ Time Frame: Baseline, Week 104 ]
    The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement.
13. Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) (Double-Blind Treatment Phase) [ Time Frame: Baseline up until a maximum of 4.5 years ]
    An Adverse Event 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. Preexisting conditions which worsen during a study are also considered as adverse events.
14. Percentage of Participants With Anti-Drug Antibodies (ADAs) (Double-Blind Treatment Phase) [ Time Frame: Baseline up until a maximum of 4.5 years ]
    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 Gantenerumab and Placebo groups. The prevalence of ADA at baseline was calculated as the proportion 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 proportion 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.
15. Mean Change From Baseline in Alzheimer Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog-11) Scores at Week 156 (OLE Phase) [ Time Frame: Baseline, Week 156 ]
    The ADAS-Cog-11 assesses multiple cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Most of these are assessed by tests although some are rated by the clinician on a 5-point scale. The score range for ADAS-Cog-11 is from 0 to 70 with higher scores representing severe dysfunction.
16. Mean Change From Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Total Score at Week 156 (OLE Phase) [ Time Frame: Baseline, Week 156 ]
    The CDR (Clinical Dementia Rating) is obtained through semi-structured interviews of participants and informants, and cognitive functioning is rated in six domains of functioning: memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated on a five-point scale of functioning as follows: 0, no impairment; 0.5, questionable impairment; 1, mild impairment; 2, moderate impairment; and 3, severe impairment. The CDR-SOB (Clinical Dementia Rating-Sum of Boxes) is based on summing each of the domain box scores with total scores ranging from 0-18, where lower total scores represent better outcomes and higher total scores represent worse outcomes.
17. Mean Change From Baseline in Alzheimer Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog-13) Scores at Week 156 (OLE Phase) [ Time Frame: Baseline, Week 156 ]
    The ADAS-Cog-13 assesses multiple cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. The score range for ADAS-Cog-13 is from 0 to 85 with higher scores representing severe dysfunction.
18. Time to Onset of Dementia at Week 156 (OLE Phase) [ Time Frame: Baseline, Week 156 ]
    Time to Onset of Dementia was defined as the time interval between the first treatment date and the date that participant is assessed as having Alzheimer-type dementia by investigators.
19. Mean Change From Baseline in Free and Cued Selective Reminding Test (FCSRT) Score at Week 156 (OLE Phase) [ Time Frame: Baseline, Week 156 ]
    FCSRT assesses verbal episodic memory. Performances in free recalls, cued recalls and in a recognition task were analyzed, as the process of encoding is controlled. Participants were asked to remember a list of 16 words. Three tasks of free and cued recalls, as well as 1 recognition task and one delayed recall give the scores. Total recall was obtained by the addition of cued recalls to free recalls. Maximum score is 48 for immediate: 16 words multiplied by (*) 3 corresponding to immediate free recall + immediate cued recall + immediate recognition test. Maximum score is 64 (better score) when delayed recall: 16 words*4. The minimum score is 0 (worse).
20. Mean Change From Baseline in Functional Activities Questionnaire (FAQ) Score at Week 156 (OLE Phase) [ Time Frame: Baseline, Week 156 ]
    Participants completed the FAQ for physical function. Overall scores ranged from 0 (independent) to 30 (dependent) where lower scores represented an improvement in physical function.
21. Mean Change From Baseline in CDR-Global Score at Week 156 (OLE Phase) [ Time Frame: Baseline, Week 156 ]
    The CDR-GS represents a semi-structured interview which rates impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care) on a 5-point scale in which CDR 0 = no dementia and CDR 0.5, 1, 2 or 3 = questionable, mild, moderate or severe dementia respectively. The range in scores for the CDR-GS is from 0 to 3 and a high score on the CDR-GS would indicate a high disease severity.
22. Percentage Change From Baseline in Hippocampal Volume at Week 152 (OLE Phase) [ Time Frame: Baseline, Week 152 ]
    Change from baseline in hippocampal right volume (HRV) and hippocampal left volume (HLV) were analysed at Week 152 using magnetic resonance imaging.
23. Percentage Change From Baseline in Cortical Composite Sustained Uptake Volume Ratio (SUVr) in Different Brain Regions at Week 156 (OLE Phase) [ Time Frame: Baseline, Week 156 ]
    The regions of the brain that were analyzed included cerebellum gray and composite reference.
24. Gantenerumab Plasma Concentrations at Different Time Points (OLE Phase) [ Time Frame: Pre-Dose: Weeks 64, 100, 104, 136, 156 and 208; Post-Dose: Week 101 ]
    The PK analyses includes tabulation of plasma concentration data and summarisation of plasma concentrations by visits with participants grouped according to treatment received. Descriptive summary statistics for the Arithmetic Mean and Standard Deviation are presented below.
25. Mean Change From Baseline in Mini Mental State Exam (MMSE) Score at Week 156 (OLE Phase) [ Time Frame: Baseline, Week 156 ]
    The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement.
26. Percentage of Participants With Anti-Drug Antibodies (ADAs) (OLE Phase) [ Time Frame: Baseline up until a maximum of 5 years ]
    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. The prevalence of ADA at baseline was calculated as the proportion 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 proportion 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.

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• Adult participants, 50-85 years of age
• Participants with prodromal Alzheimer's disease who are not receiving memantine or cholinesterase inhibitors
• Has a study partner who in the investigator's judgement has frequent and sufficient contact with the participant as to be able to provide accurate information as to the participant's cognitive and functional abilities, who agrees to provide information at clinic visits which require partner input for scale completion
• Has had sufficient education or work experience to exclude mental retardation
• Study partner has noticed a recent gradual decrease in participant's memory (over the last 12 months), which the participant may or may not be aware of
• Screening Mini Mental State Exam (MMSE) score of 24 or above

Additional inclusion criteria for sub study:

• Able and willing to travel to PET imaging center and complete the planned scanning sessions
• Past and planned exposure to ionizing radiation not exceeding safe and permissible levels

Exclusion Criteria:

• Other prior or current neurologic or medical disorder which may currently or during the course of the study impair cognition or psychiatric functioning
• A history of stroke
• A documented history of transient ischemic attack within the last 12 months
• History of schizophrenia, schizoaffective or bipolar disorder
• Currently meets criteria for major depression
• Within the last 2 years, unstable or clinical significant cardiovascular disease (myocardial infarction, angina pectoris)

Additional exclusion criteria for sub study:

• Inclusion in a research and/or medical protocol involving PET ligands or other radioactive agents within 12 months
• Present or planned participation in a research and/or medical protocol involving PET ligands or radioactive agents other than study WN25203
• Have planned or are planning to have exposure to ionizing radiation that in combination with the planned administration with study amyloid PET ligand would result in a cumulative exposure that exceeds local recommended exposure limits

Contacts and Locations

Locations

United States, Arizona

Banner Alzheimer's Institute

Phoenix, Arizona, United States, 85006

United States, California

University of California, San Diego

La Jolla, California, United States, 92037

United States, Connecticut

Yale University ADRU

New Haven, Connecticut, United States, 06510

United States, Florida

Brain Matters Research, Inc.

Delray Beach, Florida, United States, 33445

Infinity Clinical Research

Hollywood, Florida, United States, 33024

Accelerated Enrollment Solutions

Orlando, Florida, United States, 32806

Roskamp Institute, Inc.

Sarasota, Florida, United States, 34243

Compass Research

The Villages, Florida, United States, 32162

Premiere Research Institute

West Palm Beach, Florida, United States, 33407

United States, Indiana

Indiana University

Indianapolis, Indiana, United States, 46202

United States, Massachusetts

Boston Center for Memory

Newton, Massachusetts, United States, 02459

United States, Michigan

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

Kalamazoo, Michigan, United States, 49008

United States, Mississippi

Neurological Research Center

Hattiesburg, Mississippi, United States, 39401

United States, New Jersey

Princeton Medical Institute

Princeton, New Jersey, United States, 08540

United States, New York

Nathan Kline Institute

Orangeburg, New York, United States, 10962

University of Rochester Medical Center; Monroe Community Hospital

Rochester, New York, United States, 14627

United States, North Carolina

Alzheimer's Memory Center

Matthews, North Carolina, United States, 28105

United States, Oregon

Oregon Health and Science University, Layton Aging and Alzheimer's Disease Center

Portland, Oregon, United States, 97239

United States, Pennsylvania

Northeastern Pennsylvania Memory

Plains, Pennsylvania, United States, 18705

United States, Rhode Island

Rhode Island Mood & Memory Research Institute

East Providence, Rhode Island, United States, 02914

Butler Hospital

Providence, Rhode Island, United States, 02906

United States, Texas

Senior Adults Specialty Research

Austin, Texas, United States, 78757

Texas Neurology PA

Dallas, Texas, United States, 75206

United States, Vermont

Clinical Neuroscience Research Associates, Inc.

Bennington, Vermont, United States, 05201

Argentina

Hospital Italiano

Buenos Aires, Argentina, C1181ACH

IME - Instituto Médico Especializado; Ensayos Clínicos

Buenos Aires, Argentina, C1405BCH

ALPI-Inst. de Rehabilitacion Marcelo Fitte

Buenos Aires, Argentina, C1425BWO

CEMIC

Buenos Aires, Argentina, C1431FWO

Mulieris

Caba, Argentina, C1022AAO

Instituto De Neurología Cognitiva - INECO

Caba, Argentina, C1126AAB

FLENI

Caba, Argentina, C1428AQK

Instituto Kremer

Córdoba, Argentina, X5004AOA

CENPIA; Neurología - Psicología

La Plata, Argentina, B1902AJU

Australia, New South Wales

Hornsby Ku-ring-gai Hospital; Division of Rehabilitation & Aged Care

Hornsby, New South Wales, Australia, 2077

Prince of Wales Hospital, Academic Department for Old Age Psychiatry

Randwick, New South Wales, Australia, 2031

Australia, South Australia

Royal Adelaide Hospital; Memory Trials Centre

Adelaide, South Australia, Australia, 5000

The Queen Elizabeth Hospital; Neurology

Woodville, South Australia, Australia, 5011

Australia, Victoria

Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre

Heidelberg West, Victoria, Australia, 3081

Australia, Western Australia

Australian Alzheimer's Research Foundation

Nedlands, Western Australia, Australia, 6009

Belgium

UZ Leuven Gasthuisberg

Leuven, Belgium, 3000

Brazil

Hospital das Clinicas - UFPR; Ciencias da Saude

Curitiba, PR, Brazil, 80060-900

Hospital das Clinicas - UFRGS

Porto Alegre, RS, Brazil, 90035-903

Hospital Mae de Deus

Porto Alegre, RS, Brazil, 90470-340

Hospital das Clinicas - FMUSP; Psiquiatria

Sao Paulo, SP, Brazil, 05403-010

Universidade Federal de Sao Paulo - UNIFESPX; Neurologia

São Paulo, SP, Brazil, 04024-002

Canada, Nova Scotia

True North Clinical Research

New Minas, Nova Scotia, Canada, B4N 3R7

Canada, Ontario

Kawartha Centre - Redefining Healthy Aging

Peterborough, Ontario, Canada, K9H 2P4

Toronto Memory Program

Toronto, Ontario, Canada, M3B 2S7

Centre for Memory and Aging

Toronto, Ontario, Canada, M4G 3E8

Canada, Quebec

NeuroSearch Developpements inc

Greenfield Park, Quebec, Canada, J4V 2J2

McGill University; Sir Mortimer B Davis Jewish General Hospital; Neurological and Psychiatric

Montreal, Quebec, Canada, H3T 1E2

CHAUQ - Hôpital Enfant-Jésus

Quebec City, Quebec, Canada, G1J 1Z4

Chile

Biomedica Research Group

Santiago, Chile, 7500710

Especialidades Medicas LYS

Santiago, Chile, 7560356

Czechia

St. Anne´s University Hospital; Clinical Trials Department

Brno, Czechia, 656 91

Vestra Clinics s.r.o.

Rychnov nad Kneznou, Czechia, 516 01

Denmark

Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken

Aarhus N, Denmark, 8200

Rigshospitalet, Hukommelsesklinikken

Koebenhavn Oe, Denmark, 2100

Finland

CRST Oy

Turku, Finland, 20520

France

Hopital Avicenne; Neurologie

Bobigny, France, 93009

Hopital Pellegrin; Cmrr Aquitaine

Bordeaux, France, 33076

Hopital Pierre Wertheimer; Laboratoire De Neuro Psychologie

Bron, France, 69677

CHU De Caen; Service De Neurologie Dejerine

Caen, France, 14033

Hopital B Roger Salengro; Cmrr Lille

Lille, France, 59037

Ch Pitie Salpetriere; Cmrr Ile De France Salpetriere

Paris, France, 75651

CHU de Rouen Hopital; Service de Neurologie

Rouen, France, 76031

Hop Guillaume Et Rene Laennec; Cmrr St Herblain

St Herblain, France, 44800

Hopital Hautepierre; Centre dInvestigation Clinique

Strasbourg, France, 67098

Hopital de La Grave

Toulouse, France, 31059

Germany

Univ Berlin; Klin fur Psychi & Psycho Charite

Berlin, Germany, 12203

Universitätsklinikum Bonn; Medizinische Klinik und Poliklinik I; Allgemeine Innere Medizin

Bonn, Germany, 53127

Klinikum Joh.Wolfg.Goethe-UNI Zentrum d. Psychiatrie Klinik f. Psychiatrie Psychosomatik

Frankfurt, Germany, 60528

PANAKEIA - Arzneimittelforschung Leipzig GmbH

Leipzig, Germany, 04275

Zentralinstitut für Seelische Gesundheit Abt.Gerontopsychiatrie

Mannheim, Germany, 68159

Pharmakologisches Studienzentrum

Mittweida, Germany, 09648

Neurologische Praxis Dr. Andrej Pauls

München, Germany, 80331

Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie

München, Germany, 81675

Office of Dr Klaus Steinwachs Neurology & Psychiatry

Nürnberg, Germany, 90402

Universitätsklinikum Rostock Zentrum für Nervenheilkunde

Rostock, Germany, 18147

Universitätsklinikum Ulm; Klinik für Neurologie

Ulm, Germany, 89081

Italy

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

Modena, Emilia-Romagna, Italy, 41126

Universita' Di Parma Istituto Neurologia

Parma, Emilia-Romagna, Italy, 43126

Azienda Ospedaliera Spedali Civili; Scienze Neurologiche

Brescia, Lombardia, Italy, 25100

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

Brescia, Lombardia, Italy, 25125

Irccs Multimedica Santa Maria; Unita' Di Neurologia

Castellanza, Lombardia, Italy, 21053

Fondazione San Raffaele Del Monte Tabor; Dipartimento Di Neurologia

Milano, Lombardia, Italy, 20132

Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona

Torrette - Ancona, Marche, Italy, 60100

Uni Di Firenze Dip. Scienze Neurol Psic Sod Neurologia 1

Firenze, Toscana, Italy, 50134

Korea, Republic of

Seoul National University Bundang Hospital; Neurology Department

Gyeonggi-do, Korea, Republic of, 13620

Konkuk University Medical Center

Seoul, Korea, Republic of, 05030

Samsung Medical Center

Seoul, Korea, Republic of, 06351

Seoul St Mary's Hospital

Seoul, Korea, Republic of, 06591

Asan Medical Center.

Seoul, Korea, Republic of, 138-736

Mexico

Hospital Mexico Americano

Guadalajara, Mexico CITY (federal District), Mexico, 44610

Hospital Universitario; Dr. Jose E. Gonzalez

Monterrey, Nuevo LEON, Mexico, 64460

Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC

Culiacan, Mexico, 80020

Unidad de Investigacion en Enfermedades Cronico-Degenerativa; Reumatologia

Guadalajara, Mexico, 44620

Estimulacion Magnetica Trnscraneal de Mexico SC.

Mexico City, Mexico, 11000

Centro Medico San Francisco; Geriatrics

Monterrey, Mexico, 64710

Hospital Universitario de Saltillo

Saltillo, Mexico, 25000

Netherlands

Jeroen Bosch Ziekenhuis; Polikliniek Geriatrie

'S Hertogenbosch, Netherlands, 5223 GZ

Brain Research Center B.V

Amsterdam, Netherlands, 1081 GN

Poland

Podlaskie Centrum Psychogeriatrii

Białystok, Poland, 15-756

PALLMED Sp. z o.o. prowadząca NZOZ DOM SUE RYDER

Bydgoszcz, Poland, 85-796

NEURO - KARD Ośrodek Badań Klinicznych

Poznań, Poland, 61-853

Przychodnia Specjalistyczna PROSEN

Warszawa, Poland, 01-231

mMED Maciej Czarnecki

Warszawa, Poland, 01-684

Portugal

Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia

Amadora, Portugal, 2720-276

Hospital de Santa Maria; Servico de Neurologia

Lisboa, Portugal, 1649-035

Russian Federation

Sverdlovsk Regional Clinical Psychoneurological War Veteran Hospital

Ekaterinburg, Russian Federation, 620036

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

Kazan, Russian Federation, 420101

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

Saint Petersburg, Russian Federation, 190103

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

Saratov, Russian Federation, 410028

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

St. Petersburg, Russian Federation, 194044

Spain

Fundació ACE

BArcelon, Barcelona, Spain, 08034

Hospital Mutua De Terrasa; Servicio de Neurologia

Terrassa, Barcelona, Spain, 08222

Hospital de Cruces; Servicio de Neurologia

Barakaldo, Vizcaya, Spain, 48903

Hospital del Mar; Servicio de Neurologia

Barcelona, Spain, 08003

Hospital Clinic i Provincial; Servicio de Neurologia

Barcelona, Spain, 08036

Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia

Barcelona, Spain, 08041

Hospital Ramon y Cajal; Servicio de Neurologia

Madrid, Spain, 28034

Hospital Universitario 12 de Octubre; Servicio de Neurologia

Madrid, Spain, 28041

Hospital Universitario La Paz; Servicio de Neurologia

Madrid, Spain, 28046

Hospital Universitario Dr. Peset; Servicio de Neurologia

Valencia, Spain, 46017

Sweden

Skånes Universitetssjukhus Malmö, Minneskliniken

Malmö, Sweden, 211 46

Switzerland

Felix Platter-Spital Medizin Geriatrie

Basel, Switzerland, 4002

HUG; Département de santé mentale et de psychiatrie Unité de psychiatrie gériatrique

Chêne-Bourg, Switzerland, 1225

Turkey

Akdeniz University School of Medicine, Neurology Department

Antalya, Turkey, 07058

Istanbul University Istanbul School of Medicine; Neurology

Istanbul, Turkey, 34093

Ondokuz Mayis University School of Medicine; Neurology

Samsun, Turkey, 55239

United Kingdom

Addenbrooke's Hospital

Cambridge, United Kingdom, CB2 0QQ

Llandough Hospital; Llandough Hospital Memory Team 3rd Floor Academic Building

Cardiff, United Kingdom, CF64 2XX

St Margaret's Hospital

Epping, United Kingdom, CM16 6TN

Glasgow Memory Clinic

Glasgow, United Kingdom, G20 0XA

Charing Cross Hospital; Dept of Neurosciences

London, United Kingdom, W6 8RF

Campus for Ageing & Vitality; Clincal Ageing Research Unit

Newcastle, United Kingdom, NE4 5PL

Moorgreen Hospital; Memory Assessment & Rsch Ctr

Southampton, United Kingdom, SO30 3JB

Victoria Centre; Kingshill Research Centre

Swindon, United Kingdom, SN3 6BW

Hollins Park Hospital

Warrington, United Kingdom, WA2 8WA

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

  Study Documents (Full-Text)

Documents provided by Hoffmann-La Roche:

Study Protocol  [PDF] July 9, 2018

Statistical Analysis Plan  [PDF] November 13, 2020

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Ostrowitzki S, Lasser RA, Dorflinger E, Scheltens P, Barkhof F, Nikolcheva T, Ashford E, Retout S, Hofmann C, Delmar P, Klein G, Andjelkovic M, Dubois B, Boada M, Blennow K, Santarelli L, Fontoura P; SCarlet RoAD Investigators. A phase III randomized trial of gantenerumab in prodromal Alzheimer's disease. Alzheimers Res Ther. 2017 Dec 8;9(1):95. doi: 10.1186/s13195-017-0318-y. Erratum In: Alzheimers Res Ther. 2018 Sep 27;10(1):99.

Delrieu J, Ousset PJ, Vellas B. Gantenerumab for the treatment of Alzheimer's disease. Expert Opin Biol Ther. 2012 Aug;12(8):1077-86. doi: 10.1517/14712598.2012.688022. Epub 2012 May 15.

Retraction in: Expert Opin Biol Ther. 2021 Dec;21(12):1-2

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT01224106
• Other Study ID Numbers: WN25203; 2010-019895-66 ( EudraCT Number )
• First Posted: October 19, 2010
• Results First Posted: December 13, 2021
• Last Update Posted: December 13, 2021
• Last Verified: December 2021

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

Additional relevant MeSH terms:

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders