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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Gantenerumab
Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

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

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

Sites / Locations

  • Banner Alzheimer's Institute
  • University of California, San Diego
  • Yale University ADRU
  • Brain Matters Research, Inc.
  • Infinity Clinical Research
  • Accelerated Enrollment Solutions
  • Roskamp Institute, Inc.
  • Compass Research
  • Premiere Research Institute
  • Indiana University
  • Boston Center for Memory
  • Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research
  • Neurological Research Center
  • Princeton Medical Institute
  • Nathan Kline Institute
  • University of Rochester Medical Center; Monroe Community Hospital
  • Alzheimer's Memory Center
  • Oregon Health and Science University, Layton Aging and Alzheimer's Disease Center
  • Northeastern Pennsylvania Memory
  • Rhode Island Mood & Memory Research Institute
  • Butler Hospital
  • Senior Adults Specialty Research
  • Texas Neurology PA
  • Clinical Neuroscience Research Associates, Inc.
  • Hospital Italiano
  • IME - Instituto Médico Especializado; Ensayos Clínicos
  • ALPI-Inst. de Rehabilitacion Marcelo Fitte
  • CEMIC
  • Mulieris
  • Instituto De Neurología Cognitiva - INECO
  • FLENI
  • Instituto Kremer
  • CENPIA; Neurología - Psicología
  • Hornsby Ku-ring-gai Hospital; Division of Rehabilitation & Aged Care
  • Prince of Wales Hospital, Academic Department for Old Age Psychiatry
  • Royal Adelaide Hospital; Memory Trials Centre
  • The Queen Elizabeth Hospital; Neurology
  • Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre
  • Australian Alzheimer's Research Foundation
  • UZ Leuven Gasthuisberg
  • Hospital das Clinicas - UFPR; Ciencias da Saude
  • Hospital das Clinicas - UFRGS
  • Hospital Mae de Deus
  • Hospital das Clinicas - FMUSP; Psiquiatria
  • Universidade Federal de Sao Paulo - UNIFESPX; Neurologia
  • True North Clinical Research
  • Kawartha Centre - Redefining Healthy Aging
  • Toronto Memory Program
  • Centre for Memory and Aging
  • NeuroSearch Developpements inc
  • McGill University; Sir Mortimer B Davis Jewish General Hospital; Neurological and Psychiatric
  • CHAUQ - Hôpital Enfant-Jésus
  • Biomedica Research Group
  • Especialidades Medicas LYS
  • St. Anne´s University Hospital; Clinical Trials Department
  • Vestra Clinics s.r.o.
  • Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken
  • Rigshospitalet, Hukommelsesklinikken
  • CRST Oy
  • Hopital Avicenne; Neurologie
  • Hopital Pellegrin; Cmrr Aquitaine
  • Hopital Pierre Wertheimer; Laboratoire De Neuro Psychologie
  • CHU De Caen; Service De Neurologie Dejerine
  • Hopital B Roger Salengro; Cmrr Lille
  • Ch Pitie Salpetriere; Cmrr Ile De France Salpetriere
  • CHU de Rouen Hopital; Service de Neurologie
  • Hop Guillaume Et Rene Laennec; Cmrr St Herblain
  • Hopital Hautepierre; Centre dInvestigation Clinique
  • Hopital de La Grave
  • Univ Berlin; Klin fur Psychi & Psycho Charite
  • Universitätsklinikum Bonn; Medizinische Klinik und Poliklinik I; Allgemeine Innere Medizin
  • Klinikum Joh.Wolfg.Goethe-UNI Zentrum d. Psychiatrie Klinik f. Psychiatrie Psychosomatik
  • PANAKEIA - Arzneimittelforschung Leipzig GmbH
  • Zentralinstitut für Seelische Gesundheit Abt.Gerontopsychiatrie
  • Pharmakologisches Studienzentrum
  • Neurologische Praxis Dr. Andrej Pauls
  • Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie
  • Office of Dr Klaus Steinwachs Neurology & Psychiatry
  • Universitätsklinikum Rostock Zentrum für Nervenheilkunde
  • Universitätsklinikum Ulm; Klinik für Neurologie
  • Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica - Dipartimento di Neuroscienze
  • Universita' Di Parma Istituto Neurologia
  • Azienda Ospedaliera Spedali Civili; Scienze Neurologiche
  • IRCCS "Centro S. Giovanni di Dio" Fatebenefratelli -UO Alzheimer
  • Irccs Multimedica Santa Maria; Unita' Di Neurologia
  • Fondazione San Raffaele Del Monte Tabor; Dipartimento Di Neurologia
  • Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona
  • Uni Di Firenze Dip. Scienze Neurol Psic Sod Neurologia 1
  • Seoul National University Bundang Hospital; Neurology Department
  • Konkuk University Medical Center
  • Samsung Medical Center
  • Seoul St Mary's Hospital
  • Asan Medical Center.
  • Hospital Mexico Americano
  • Hospital Universitario; Dr. Jose E. Gonzalez
  • Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC
  • Unidad de Investigacion en Enfermedades Cronico-Degenerativa; Reumatologia
  • Estimulacion Magnetica Trnscraneal de Mexico SC.
  • Centro Medico San Francisco; Geriatrics
  • Hospital Universitario de Saltillo
  • Jeroen Bosch Ziekenhuis; Polikliniek Geriatrie
  • Brain Research Center B.V
  • Podlaskie Centrum Psychogeriatrii
  • PALLMED Sp. z o.o. prowadząca NZOZ DOM SUE RYDER
  • NEURO - KARD Ośrodek Badań Klinicznych
  • Przychodnia Specjalistyczna PROSEN
  • mMED Maciej Czarnecki
  • Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia
  • Hospital de Santa Maria; Servico de Neurologia
  • Sverdlovsk Regional Clinical Psychoneurological War Veteran Hospital
  • State autonomous institution of healthcare Inter-regional clinical and diagnostic center
  • 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
  • Fundació ACE
  • Hospital Mutua De Terrasa; Servicio de Neurologia
  • Hospital de Cruces; Servicio de Neurologia
  • Hospital del Mar; Servicio de Neurologia
  • Hospital Clinic i Provincial; Servicio de Neurologia
  • Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
  • Hospital Ramon y Cajal; Servicio de Neurologia
  • Hospital Universitario 12 de Octubre; Servicio de Neurologia
  • Hospital Universitario La Paz; Servicio de Neurologia
  • Hospital Universitario Dr. Peset; Servicio de Neurologia
  • Skånes Universitetssjukhus Malmö, Minneskliniken
  • Felix Platter-Spital Medizin Geriatrie
  • HUG; Département de santé mentale et de psychiatrie Unité de psychiatrie gériatrique
  • Akdeniz University School of Medicine, Neurology Department
  • Istanbul University Istanbul School of Medicine; Neurology
  • Ondokuz Mayis University School of Medicine; Neurology
  • Addenbrooke's Hospital
  • Llandough Hospital; Llandough Hospital Memory Team 3rd Floor Academic Building
  • St Margaret's Hospital
  • Glasgow Memory Clinic
  • Charing Cross Hospital; Dept of Neurosciences
  • Campus for Ageing & Vitality; Clincal Ageing Research Unit
  • Moorgreen Hospital; Memory Assessment & Rsch Ctr
  • Victoria Centre; Kingshill Research Centre
  • Hollins Park Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

Placebo (Parts 1 and 2)

Gantenerumab 105 mg (Parts 1 and 2)

Gantenerumab 225 mg (Parts 1 and 2)

Placebo (Parts 1 and 2) switched to Gantenerumab Up to 1200mg (Part 3 Open-Label Extension [OLE])

Gantenerumab Up to 1200 mg (Part 3 Open-Label Extension [OLE])

Arm Description

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Mean Change From Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Total Score at Week 104 (Double-Blind Treatment Phase)
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.
Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) (OLE Phase)
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

Mean Change From Baseline in Alzheimer Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog-11) Scores at Week 104 (Double-Blind Treatment Phase)
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.
Time to Onset of Dementia at Week 104 (Double-Blind Treatment Phase)
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.
Mean Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Composite Score at Week 104 (Double-Blind Treatment Phase)
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.
Mean Change From Baseline in Free and Cued Selective Reminding Test (FCSRT) Score at Week 104 (Double-Blind Treatment Phase)
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).
Mean Change From Baseline in Functional Activities Questionnaire (FAQ) Score at Week 104 (Double-Blind Treatment Phase)
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.
Mean Change From Baseline in CDR-Global Score at Week 104 (Double-Blind Treatment Phase)
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.
Mean Change From Baseline in Neuropsychiatric Inventory (NPI) Questionnaire Score at Week 104 (Double-Blind Treatment Phase)
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).
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)
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.
Percentage Change From Baseline in Hippocampal Volume at Week 104 (Double-Blind Treatment Phase)
Change from baseline in hippocampal right volume (HRV) and hippocampal left volume (HLV) were analysed at Week 104 using magnetic resonance imaging.
Percentage Change From Baseline in Cortical Composite Sustained Uptake Volume Ratio (SUVr) in Different Brain Regions at Week 156 (Double-Blind Treatment Phase)
The different regions of the brain that were analyzed included cerebellum gray, whole cerebellum, composite white matter, subcortical white matter, pons and composite reference.
Gantenerumab Plasma Concentrations at Different Time Points (Double-Blind Treatment Phase)
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.
Mean Change From Baseline in Mini Mental State Exam (MMSE) Score at Week 104 (Double-Blind Treatment Phase)
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.
Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) (Double-Blind Treatment Phase)
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.
Percentage of Participants With Anti-Drug Antibodies (ADAs) (Double-Blind Treatment Phase)
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.
Mean Change From Baseline in Alzheimer Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog-11) Scores at Week 156 (OLE Phase)
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.
Mean Change From Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Total Score at Week 156 (OLE Phase)
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.
Mean Change From Baseline in Alzheimer Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog-13) Scores at Week 156 (OLE Phase)
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.
Time to Onset of Dementia at Week 156 (OLE Phase)
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.
Mean Change From Baseline in Free and Cued Selective Reminding Test (FCSRT) Score at Week 156 (OLE Phase)
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).
Mean Change From Baseline in Functional Activities Questionnaire (FAQ) Score at Week 156 (OLE Phase)
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.
Mean Change From Baseline in CDR-Global Score at Week 156 (OLE Phase)
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.
Percentage Change From Baseline in Hippocampal Volume at Week 152 (OLE Phase)
Change from baseline in hippocampal right volume (HRV) and hippocampal left volume (HLV) were analysed at Week 152 using magnetic resonance imaging.
Percentage Change From Baseline in Cortical Composite Sustained Uptake Volume Ratio (SUVr) in Different Brain Regions at Week 156 (OLE Phase)
The regions of the brain that were analyzed included cerebellum gray and composite reference.
Gantenerumab Plasma Concentrations at Different Time Points (OLE Phase)
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.
Mean Change From Baseline in Mini Mental State Exam (MMSE) Score at Week 156 (OLE Phase)
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.
Percentage of Participants With Anti-Drug Antibodies (ADAs) (OLE Phase)
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.

Full Information

First Posted
October 14, 2010
Last Updated
December 10, 2021
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01224106
Brief Title
A Study of Gantenerumab in Participants With Prodromal Alzheimer's Disease
Acronym
Scarlet Road
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
November 30, 2010 (Actual)
Primary Completion Date
September 10, 2020 (Actual)
Study Completion Date
September 10, 2020 (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
No

5. 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.

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
799 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo (Parts 1 and 2)
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Gantenerumab 105 mg (Parts 1 and 2)
Arm Type
Experimental
Arm Description
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.
Arm Title
Gantenerumab 225 mg (Parts 1 and 2)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo (Parts 1 and 2) switched to Gantenerumab Up to 1200mg (Part 3 Open-Label Extension [OLE])
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Gantenerumab Up to 1200 mg (Part 3 Open-Label Extension [OLE])
Arm Type
Experimental
Arm Description
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.
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants received Placebo SC injection Q4W.
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Total Score at Week 104 (Double-Blind Treatment Phase)
Description
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.
Time Frame
Baseline, Week 104
Title
Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) (OLE Phase)
Description
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.
Time Frame
Baseline up until a maximum of 5 years
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Alzheimer Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog-11) Scores at Week 104 (Double-Blind Treatment Phase)
Description
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.
Time Frame
Baseline, Week 104
Title
Time to Onset of Dementia at Week 104 (Double-Blind Treatment Phase)
Description
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.
Time Frame
Baseline, Week 104
Title
Mean Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Composite Score at Week 104 (Double-Blind Treatment Phase)
Description
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.
Time Frame
Baseline, Week 104
Title
Mean Change From Baseline in Free and Cued Selective Reminding Test (FCSRT) Score at Week 104 (Double-Blind Treatment Phase)
Description
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).
Time Frame
Baseline, Week 104
Title
Mean Change From Baseline in Functional Activities Questionnaire (FAQ) Score at Week 104 (Double-Blind Treatment Phase)
Description
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.
Time Frame
Baseline, Week 104
Title
Mean Change From Baseline in CDR-Global Score at Week 104 (Double-Blind Treatment Phase)
Description
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.
Time Frame
Baseline, Week 104
Title
Mean Change From Baseline in Neuropsychiatric Inventory (NPI) Questionnaire Score at Week 104 (Double-Blind Treatment Phase)
Description
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).
Time Frame
Baseline, Week 104
Title
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)
Description
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.
Time Frame
Baseline, Week 104
Title
Percentage Change From Baseline in Hippocampal Volume at Week 104 (Double-Blind Treatment Phase)
Description
Change from baseline in hippocampal right volume (HRV) and hippocampal left volume (HLV) were analysed at Week 104 using magnetic resonance imaging.
Time Frame
Baseline, Week 104
Title
Percentage Change From Baseline in Cortical Composite Sustained Uptake Volume Ratio (SUVr) in Different Brain Regions at Week 156 (Double-Blind Treatment Phase)
Description
The different regions of the brain that were analyzed included cerebellum gray, whole cerebellum, composite white matter, subcortical white matter, pons and composite reference.
Time Frame
Baseline, Week 156
Title
Gantenerumab Plasma Concentrations at Different Time Points (Double-Blind Treatment Phase)
Description
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.
Time Frame
Pre-Dose: Weeks 8, 20, 44, 68 and 100; Post-Dose: Weeks 1, 53 and 101
Title
Mean Change From Baseline in Mini Mental State Exam (MMSE) Score at Week 104 (Double-Blind Treatment Phase)
Description
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.
Time Frame
Baseline, Week 104
Title
Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) (Double-Blind Treatment Phase)
Description
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.
Time Frame
Baseline up until a maximum of 4.5 years
Title
Percentage of Participants With Anti-Drug Antibodies (ADAs) (Double-Blind Treatment Phase)
Description
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.
Time Frame
Baseline up until a maximum of 4.5 years
Title
Mean Change From Baseline in Alzheimer Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog-11) Scores at Week 156 (OLE Phase)
Description
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.
Time Frame
Baseline, Week 156
Title
Mean Change From Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Total Score at Week 156 (OLE Phase)
Description
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.
Time Frame
Baseline, Week 156
Title
Mean Change From Baseline in Alzheimer Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog-13) Scores at Week 156 (OLE Phase)
Description
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.
Time Frame
Baseline, Week 156
Title
Time to Onset of Dementia at Week 156 (OLE Phase)
Description
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.
Time Frame
Baseline, Week 156
Title
Mean Change From Baseline in Free and Cued Selective Reminding Test (FCSRT) Score at Week 156 (OLE Phase)
Description
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).
Time Frame
Baseline, Week 156
Title
Mean Change From Baseline in Functional Activities Questionnaire (FAQ) Score at Week 156 (OLE Phase)
Description
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.
Time Frame
Baseline, Week 156
Title
Mean Change From Baseline in CDR-Global Score at Week 156 (OLE Phase)
Description
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.
Time Frame
Baseline, Week 156
Title
Percentage Change From Baseline in Hippocampal Volume at Week 152 (OLE Phase)
Description
Change from baseline in hippocampal right volume (HRV) and hippocampal left volume (HLV) were analysed at Week 152 using magnetic resonance imaging.
Time Frame
Baseline, Week 152
Title
Percentage Change From Baseline in Cortical Composite Sustained Uptake Volume Ratio (SUVr) in Different Brain Regions at Week 156 (OLE Phase)
Description
The regions of the brain that were analyzed included cerebellum gray and composite reference.
Time Frame
Baseline, Week 156
Title
Gantenerumab Plasma Concentrations at Different Time Points (OLE Phase)
Description
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.
Time Frame
Pre-Dose: Weeks 64, 100, 104, 136, 156 and 208; Post-Dose: Week 101
Title
Mean Change From Baseline in Mini Mental State Exam (MMSE) Score at Week 156 (OLE Phase)
Description
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.
Time Frame
Baseline, Week 156
Title
Percentage of Participants With Anti-Drug Antibodies (ADAs) (OLE Phase)
Description
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.
Time Frame
Baseline up until a maximum of 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
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 Alzheimer's Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Yale University ADRU
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Brain Matters Research, Inc.
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Infinity Clinical Research
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Accelerated Enrollment Solutions
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Roskamp Institute, Inc.
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
Facility Name
Compass Research
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Facility Name
Premiere Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Boston Center for Memory
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
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
Neurological Research Center
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
Princeton Medical Institute
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Nathan Kline Institute
City
Orangeburg
State/Province
New York
ZIP/Postal Code
10962
Country
United States
Facility Name
University of Rochester Medical Center; Monroe Community Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14627
Country
United States
Facility Name
Alzheimer's Memory Center
City
Matthews
State/Province
North Carolina
ZIP/Postal Code
28105
Country
United States
Facility Name
Oregon Health and Science University, Layton Aging and Alzheimer's Disease Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
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
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Senior Adults Specialty Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
Texas Neurology PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75206
Country
United States
Facility Name
Clinical Neuroscience Research Associates, Inc.
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
Hospital Italiano
City
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
IME - Instituto Médico Especializado; Ensayos Clínicos
City
Buenos Aires
ZIP/Postal Code
C1405BCH
Country
Argentina
Facility Name
ALPI-Inst. de Rehabilitacion Marcelo Fitte
City
Buenos Aires
ZIP/Postal Code
C1425BWO
Country
Argentina
Facility Name
CEMIC
City
Buenos Aires
ZIP/Postal Code
C1431FWO
Country
Argentina
Facility Name
Mulieris
City
Caba
ZIP/Postal Code
C1022AAO
Country
Argentina
Facility Name
Instituto De Neurología Cognitiva - INECO
City
Caba
ZIP/Postal Code
C1126AAB
Country
Argentina
Facility Name
FLENI
City
Caba
ZIP/Postal Code
C1428AQK
Country
Argentina
Facility Name
Instituto Kremer
City
Córdoba
ZIP/Postal Code
X5004AOA
Country
Argentina
Facility Name
CENPIA; Neurología - Psicología
City
La Plata
ZIP/Postal Code
B1902AJU
Country
Argentina
Facility Name
Hornsby Ku-ring-gai Hospital; Division of Rehabilitation & Aged Care
City
Hornsby
State/Province
New South Wales
ZIP/Postal Code
2077
Country
Australia
Facility Name
Prince of Wales Hospital, Academic Department for Old Age Psychiatry
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
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
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Hospital das Clinicas - UFPR; Ciencias da Saude
City
Curitiba
State/Province
PR
ZIP/Postal Code
80060-900
Country
Brazil
Facility Name
Hospital das Clinicas - UFRGS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Hospital Mae de Deus
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90470-340
Country
Brazil
Facility Name
Hospital das Clinicas - FMUSP; Psiquiatria
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-010
Country
Brazil
Facility Name
Universidade Federal de Sao Paulo - UNIFESPX; Neurologia
City
São Paulo
State/Province
SP
ZIP/Postal Code
04024-002
Country
Brazil
Facility Name
True North Clinical Research
City
New Minas
State/Province
Nova Scotia
ZIP/Postal Code
B4N 3R7
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
Centre for Memory and Aging
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3E8
Country
Canada
Facility Name
NeuroSearch Developpements inc
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Facility Name
McGill University; Sir Mortimer B Davis Jewish General Hospital; Neurological and Psychiatric
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
CHAUQ - Hôpital Enfant-Jésus
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Biomedica Research Group
City
Santiago
ZIP/Postal Code
7500710
Country
Chile
Facility Name
Especialidades Medicas LYS
City
Santiago
ZIP/Postal Code
7560356
Country
Chile
Facility Name
St. Anne´s University Hospital; Clinical Trials Department
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Vestra Clinics s.r.o.
City
Rychnov nad Kneznou
ZIP/Postal Code
516 01
Country
Czechia
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
CRST Oy
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Hopital Avicenne; Neurologie
City
Bobigny
ZIP/Postal Code
93009
Country
France
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 Caen; Service De Neurologie Dejerine
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hopital B Roger Salengro; Cmrr Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Ch Pitie Salpetriere; Cmrr Ile De France Salpetriere
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
CHU de Rouen Hopital; Service de Neurologie
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Hop Guillaume Et Rene Laennec; Cmrr St Herblain
City
St Herblain
ZIP/Postal Code
44800
Country
France
Facility Name
Hopital Hautepierre; Centre dInvestigation Clinique
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Hopital de La Grave
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Univ Berlin; Klin fur Psychi & Psycho Charite
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Universitätsklinikum Bonn; Medizinische Klinik und Poliklinik I; Allgemeine Innere Medizin
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Klinikum Joh.Wolfg.Goethe-UNI Zentrum d. Psychiatrie Klinik f. Psychiatrie Psychosomatik
City
Frankfurt
ZIP/Postal Code
60528
Country
Germany
Facility Name
PANAKEIA - Arzneimittelforschung Leipzig GmbH
City
Leipzig
ZIP/Postal Code
04275
Country
Germany
Facility Name
Zentralinstitut für Seelische Gesundheit Abt.Gerontopsychiatrie
City
Mannheim
ZIP/Postal Code
68159
Country
Germany
Facility Name
Pharmakologisches Studienzentrum
City
Mittweida
ZIP/Postal Code
09648
Country
Germany
Facility Name
Neurologische Praxis Dr. Andrej Pauls
City
München
ZIP/Postal Code
80331
Country
Germany
Facility Name
Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Office of Dr Klaus Steinwachs Neurology & Psychiatry
City
Nürnberg
ZIP/Postal Code
90402
Country
Germany
Facility Name
Universitätsklinikum Rostock Zentrum für Nervenheilkunde
City
Rostock
ZIP/Postal Code
18147
Country
Germany
Facility Name
Universitätsklinikum Ulm; Klinik für Neurologie
City
Ulm
ZIP/Postal Code
89081
Country
Germany
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
Universita' Di Parma Istituto Neurologia
City
Parma
State/Province
Emilia-Romagna
ZIP/Postal Code
43126
Country
Italy
Facility Name
Azienda Ospedaliera Spedali Civili; Scienze Neurologiche
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25100
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
Fondazione San Raffaele Del Monte Tabor; Dipartimento Di Neurologia
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona
City
Torrette - Ancona
State/Province
Marche
ZIP/Postal Code
60100
Country
Italy
Facility Name
Uni Di Firenze Dip. Scienze Neurol Psic Sod Neurologia 1
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Facility Name
Seoul National University Bundang Hospital; Neurology Department
City
Gyeonggi-do
ZIP/Postal Code
13620
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
Seoul St Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Asan Medical Center.
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Hospital Mexico Americano
City
Guadalajara
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
44610
Country
Mexico
Facility Name
Hospital Universitario; Dr. Jose E. Gonzalez
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC
City
Culiacan
ZIP/Postal Code
80020
Country
Mexico
Facility Name
Unidad de Investigacion en Enfermedades Cronico-Degenerativa; Reumatologia
City
Guadalajara
ZIP/Postal Code
44620
Country
Mexico
Facility Name
Estimulacion Magnetica Trnscraneal de Mexico SC.
City
Mexico City
ZIP/Postal Code
11000
Country
Mexico
Facility Name
Centro Medico San Francisco; Geriatrics
City
Monterrey
ZIP/Postal Code
64710
Country
Mexico
Facility Name
Hospital Universitario de Saltillo
City
Saltillo
ZIP/Postal Code
25000
Country
Mexico
Facility Name
Jeroen Bosch Ziekenhuis; Polikliniek Geriatrie
City
'S Hertogenbosch
ZIP/Postal Code
5223 GZ
Country
Netherlands
Facility Name
Brain Research Center B.V
City
Amsterdam
ZIP/Postal Code
1081 GN
Country
Netherlands
Facility Name
Podlaskie Centrum Psychogeriatrii
City
Białystok
ZIP/Postal Code
15-756
Country
Poland
Facility Name
PALLMED Sp. z o.o. prowadząca NZOZ DOM SUE RYDER
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
NEURO - KARD Ośrodek Badań Klinicznych
City
Poznań
ZIP/Postal Code
61-853
Country
Poland
Facility Name
Przychodnia Specjalistyczna PROSEN
City
Warszawa
ZIP/Postal Code
01-231
Country
Poland
Facility Name
mMED Maciej Czarnecki
City
Warszawa
ZIP/Postal Code
01-684
Country
Poland
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
Sverdlovsk Regional Clinical Psychoneurological War Veteran Hospital
City
Ekaterinburg
ZIP/Postal Code
620036
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
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
Fundació ACE
City
BArcelon
State/Province
Barcelona
ZIP/Postal Code
08034
Country
Spain
Facility Name
Hospital Mutua De Terrasa; Servicio de Neurologia
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08222
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 Clinic i Provincial; Servicio de Neurologia
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Ramon y Cajal; Servicio de Neurologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Neurologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz; Servicio de Neurologia
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Dr. Peset; Servicio de Neurologia
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Skånes Universitetssjukhus Malmö, Minneskliniken
City
Malmö
ZIP/Postal Code
211 46
Country
Sweden
Facility Name
Felix Platter-Spital Medizin Geriatrie
City
Basel
ZIP/Postal Code
4002
Country
Switzerland
Facility Name
HUG; Département de santé mentale et de psychiatrie Unité de psychiatrie gériatrique
City
Chêne-Bourg
ZIP/Postal Code
1225
Country
Switzerland
Facility Name
Akdeniz University School of Medicine, Neurology Department
City
Antalya
ZIP/Postal Code
07058
Country
Turkey
Facility Name
Istanbul University Istanbul School of Medicine; Neurology
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Ondokuz Mayis University School of Medicine; Neurology
City
Samsun
ZIP/Postal Code
55239
Country
Turkey
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Llandough Hospital; Llandough Hospital Memory Team 3rd Floor Academic Building
City
Cardiff
ZIP/Postal Code
CF64 2XX
Country
United Kingdom
Facility Name
St Margaret's Hospital
City
Epping
ZIP/Postal Code
CM16 6TN
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
Campus for Ageing & Vitality; Clincal Ageing Research Unit
City
Newcastle
ZIP/Postal Code
NE4 5PL
Country
United Kingdom
Facility Name
Moorgreen Hospital; Memory Assessment & Rsch Ctr
City
Southampton
ZIP/Postal Code
SO30 3JB
Country
United Kingdom
Facility Name
Victoria Centre; Kingshill Research Centre
City
Swindon
ZIP/Postal Code
SN3 6BW
Country
United Kingdom
Facility Name
Hollins Park Hospital
City
Warrington
ZIP/Postal Code
WA2 8WA
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
PubMed Identifier
29221491
Citation
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.
Results Reference
derived
PubMed Identifier
22583155
Citation
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.
Results Reference
derived

Learn more about this trial

A Study of Gantenerumab in Participants With Prodromal Alzheimer's Disease

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