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Alzheimer's DiseasePhase 3NCT02051608

A Study of Gantenerumab in Participants With Mild Alzheimer Disease

A Phase 3 study testing Gantenerumab in people with Alzheimer's Disease, run by Hoffmann-La Roche at 131 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Part 1 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of gantenerumab in participants with mild Alzheimer disease. Read more about this study

Who is it for?
Ages 50 to 90 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
Gantenerumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
389 participants
Where
131 sitesin 22 countries
Study dates
27 Mar 2014to 16 Apr 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of probable mild Alzheimer disease (AD) based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria or major NCD based whether or not receiving AD approved medication
  • Cerebral spinal fluid (CSF) result consistent with the presence of amyloid pathology
  • Availability of a person ('caregiver') who in the investigator's judgment has frequent and sufficient contact with the participant, and is able to provide accurate information regarding the participant's cognitive and functional abilities
  • Fluency in the language of the tests used at the study site
  • Willingness and ability to complete all aspects of the study
  • Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eye glasses and hearing aids are permitted)
Show all 9Show fewer
  • If currently receiving approved medications for AD, the dosing regimen must have been stable for 3 months prior to screening
  • Agreement not to participate in other research studies for the duration of this trial and its associated substudies
  • PART 2 - All participants who have been randomized and are actively participating in the study are eligible for Part 2

Who cannot join

  • Dementia or neurocognitive disorder (NCD) due to a condition other than AD, including, but not limited to, frontotemporal dementia, Parkinson disease, dementia with Lewy bodies, Huntington disease, or vascular dementia
  • History or presence of clinically evident vascular disease potentially affecting the brain that in the opinion of the investigator has the potential to affect cognitive function
  • History or presence of stroke within the past 2 years or documented history of transient ischemic attack within the last 12 months
  • History or presence of systemic autoimmune disorders potentially causing progressive neurologic disease with associated cognitive deficits
  • History of schizophrenia, schizoaffective disorder, or bipolar disorder
  • Alcohol and/or substance use disorder (according to the DSM-5) within the past 2 years (nicotine use is allowed)
Show all 14Show fewer
  • History or presence of atrial fibrillation
  • Within the last 2 years, unstable or clinically significant cardiovascular disease (e.g., myocardial infarction, angina pectoris, cardiac failure New York Heart Association Class II or higher)
  • Uncontrolled hypertension
  • Chronic kidney disease
  • Impaired hepatic function
  • PET imaging substudy, in addition to above:
  • Prior participation in other research study or clinical care within the last year such that the total radiation exposure would exceed the local or national annual limits
  • Part 2 Participants who have been discontinued from the study

Trial locations and contacts

131 sites in 22 countries.

131 sites in 22 countries

United States30 sites

  • Abington Neurological Associates

    Abington, Pennsylvania, 19001

  • Senior Adults Specialty Research

    Austin, Texas, 78757

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808

  • Meridien Research

    Brooksville, Florida, 34601

  • Neurology Clinic PC

    Cordova, Tennessee, 38018

  • ATP Clinical Research, Inc

    Costa Mesa, California, 92626

  • Brain Matters Research, Inc.

    Delray Beach, Florida, 33445

  • Rhode Island Mood & Memory Research Institute

    East Providence, Rhode Island, 02914

  • Neuropsychiatric Research; Center of Southwest Florida

    Fort Myers, Florida, 33912

  • Indiana University

    Indianapolis, Indiana, 46202

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

    Kalamazoo, Michigan, 49008

  • Alzheimer's Memory Center

    Matthews, North Carolina, 28105

  • Miami Jewish Health Systems; Clinical Research

    Miami, Florida, 33137

  • Louisiana Research Associates

    New Orleans, Louisiana, 70114

  • Nathan Kline Institute

    Orangeburg, New York, 10962

  • Accelerated Enrollment Solutions

    Orlando, Florida, 32806

  • Alzheimer's Research Corporation

    Paterson, New Jersey, 08759

  • Northeastern Pennsylvania Memory

    Plains, Pennsylvania, 18705

  • Richard H Weisler, MD

    Raleigh, North Carolina, 27609

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

    Salt Lake City, Utah, 84108

  • Pacific Research Network - PRN

    San Diego, California, 92103

  • California Neuroscience Research Medical Group, Inc

    Sherman Oaks, California, 91403

  • Millennium Psychiatric Associates, LLC

    St Louis, Missouri, 63132

  • Richmond Behavioral Associates

    Staten Island, New York, 10312

  • Banner Sun Health Research Insitute

    Sun City, Arizona, 85351

  • University of South Florida

    Tampa, Florida, 33613-4706

  • Ocean Rheumatology

    Toms River, New Jersey, 08775

  • Territory Neurology and Research Institute

    Tucson, Arizona, 85704

  • Central States Research

    Tulsa, Oklahoma, 74136

  • Alzheimer's Research and Treatment Center

    Wellington, Florida, 33414

Other trials in United States

Canada14 sites

  • Jbn Medical Diagnostic Services Inc.

    Burlington, Ontario, L7M 4Y1

  • University of Calgary; Heritage Medical Research Clinic

    Calgary, Alberta, T2N 4Z6

  • Recherches Neuro-Hippocame

    Gatineau, Quebec, J8T 8J1

  • NeuroSearch Developpements inc

    Greenfield Park, Quebec, J4V 2J2

  • True North Clinical Research-Halifax

    Halifax, Nova Scotia, B3S 1N2

  • Parkwood Hospital; Geriatric Medicine

    London, Ontario, N6C 5J1

  • Jewish General Hospital / McGill University

    Montreal, Quebec, H3T 1E2

  • True North Clinical Research

    New Minas, Nova Scotia, B4N 3R7

  • Kawartha Centre - Redefining Healthy Aging

    Peterborough, Ontario, K9H 2P4

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

    Québec, Quebec, G1J 1Z4

  • Alpha Recherche Clinique

    Québec, G3K 2P8

  • Toronto Memory Program

    Toronto, Ontario, M3B 2S7

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

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

    Verdun, Quebec, H4H 1R3

Other trials in Canada

Japan11 sites

  • Medical Corporation Hakuyokai Kashiwado Hospital

    Chiba, 260-8656

  • National Hospital Organization Chiba-east Hospital; Neurology

    Chiba, 260-8712

  • Juntendo University Urayasu Hospital; Neurology

    Chiba, 279-0021

  • Fukuoka University Hospital; Neurology and Health Care

    Fukuoka, 814-0180

  • Maebashi Red Cross Hospital; Neurology

    Gunma, 371-0014

  • National Hospital Organization Hiroshima-Nishi Medical Center

    Hiroshima, 739-0696

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

    Hyōgo, 670-0981

  • Shonan Kamakura General Hospital; Neurology

    Kanagawa, 247-8533

  • Oita University Hospital; Neurology

    Ōita, 879-5593

  • Kurashiki Heisei Hospital; Neurology

    Okayama, 710-0826

  • Shizuoka City Shimizu Hospital; Neurology

    Shizuoka, 424-0911

Other trials in Japan

South Korea9 sites

  • Dong-A University Medical Center

    Busan, 602-715

  • Seoul National University Bundang Hospital; Neurology Department

    Gyeonggi-do, 13620

  • Inha University Hospital; Neurology Department

    Incheon, 22332

  • Konkuk University Medical Center

    Seoul, 05030

  • Samsung Medical Center

    Seoul, 06351

  • Ewha Womans University Hospital (Seoul)

    Seoul, 07804

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

    Seoul, 137-701

  • Asan Medical Center.

    Seoul, 138-736

  • Ewha Womans University Mokdong Hospital; Dept of Neurology

    Seoul, 158-710

Other trials in South Korea

Spain8 sites

  • Hospital de Cruces; Servicio de Neurologia

    Barakaldo, Vizcaya, 48903

  • Fundació ACE

    BArcelon, Barcelona, 08034

  • Hospital del Mar; Servicio de Neurologia

    Barcelona, 08003

  • Policlínica Guipuzkoa; Servicio de Neurología

    Donosti-San Sebastián, Guipuzcoa, 20014

  • Hospital General Universitario de Elche; Servicio de Neurología

    Elche, Alicante, 03203

  • Hospital Universitario 12 de Octubre; Servicio de Neurologia

    Madrid, 28041

  • Hospital Universitario Virgen Macarena; Servicio de Neurologia

    Seville, 41009

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

France7 sites

  • Hopital Pellegrin; Cmrr Aquitaine

    Bordeaux, 33076

  • Hopital Pierre Wertheimer; Laboratoire De Neuro Psychologie

    Bron, 69677

  • CHU de Limoges Hopital Dupuytren; Service de Medecine Geriatrique

    Limoges, 87042

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

    Marseille, 13005

  • CHU Rennes - hopital Hotel Dieu; Consultation Memoire - Gerontologie

    Rennes, 35064

  • Hopital Hautepierre; Centre dInvestigation Clinique

    Strasbourg, 67098

  • Hopital la Grave; Gerontopole - Centre de Recherche Clinique

    Toulouse, 31059

Other trials in France

Germany7 sites

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

    Berlin, 13125

  • PANAKEIA - Arzneimittelforschung Leipzig GmbH

    Leipzig, 04275

  • Pharmakologisches Studienzentrum

    Mittweida, 09648

  • Neurologische Praxis Dr. Andrej Pauls

    München, 80331

  • Klinikum rechts der Isar der TU München; Klinikapotheke

    München, 81675

  • Universitätsklinikum Ulm; Klinik für Neurologie

    Ulm, 89081

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

    Westerstede, 26655

Other trials in Germany

Italy7 sites

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

    Brescia, Lombardy, 25125

  • Irccs Multimedica Santa Maria; Unita' Di Neurologia

    Castellanza, Lombardy, 21053

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

    Modena, Emilia-Romagna, 41126

  • ASST DI MONZA; Neurologia

    Monza, Lombardy, 20900

  • A.O. Universitaria Pisana; Neurologia

    Pisa, Tuscany, 56126

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata; Neurologia

    Rome, Lazio, 00133

  • Umberto I Policlinico di Roma-Università di Roma La Sapienza

    Rome, Lazio, 00185

Other trials in Italy

Russia7 sites

  • State Autonomous Healthcare Institution "Republican Clinical Neurological Center

    Kazan', 420021

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

    Kazan', 420101

  • Institution of RAMS (Mental Health Research Center of RAMS)

    Moscow, 115522

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

    Moscow, 119021

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

    Saint Petersburg, 190103

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

    Saint Petersburg, 194044

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

    Saratov, 410028

Other trials in Russia

United Kingdom6 sites

  • Sussex Partnership NHS Foundation Trust; Cognitive Treatment and Research unit

    Crowborough, TN6 1HB

  • Glasgow Memory Clinic

    Glasgow, G20 0XA

  • Charing Cross Hospital; Dept of Neurosciences

    London, W6 8RF

  • Manchester Royal Infirmary

    Manchester, M13 9WL

  • Royal Preston Hosptial

    Preston, PR2 9HT

  • Memory Service North

    Sheffield, S35 8QS

Other trials in United Kingdom

Australia4 sites

  • Royal Adelaide Hospital; Memory Trials Centre

    Adelaide, South Australia, 5000

  • Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre

    Heidelberg West, Victoria, 3081

  • Australian Alzheimer's Research Foundation

    Nedlands, Western Australia, 6009

  • The Queen Elizabeth Hospital; Neurology

    Woodville, South Australia, 5011

Other trials in Australia

Turkey (Türkiye)3 sites

  • Istanbul University Istanbul School of Medicine; Neurology

    Istanbul, 34093

  • Dokuz Eylul University Medicine Faculty; Noroloji Departmani

    Izmir, 35340

  • Ondokuz Mayis University School of Medicine; Neurology

    Samsun, 55139

Other trials in Turkey (Türkiye)

Belgium2 sites

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • UZ Leuven Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Bulgaria2 sites

  • Shat Np Sveti Naum; 3Rd Clinic of Neurology

    Sofia, 1113

  • MBAL St. Marina; First Neurology Department

    Varna, 9010

Other trials in Bulgaria

Denmark2 sites

  • Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken

    Aarhus N, 8200

  • Rigshospitalet, Hukommelsesklinikken

    Koebenhavn Oe, 2100

Other trials in Denmark

Finland2 sites

  • University of Eastern Finland

    Kuopio, 70210

  • CRST Oy

    Turku, 20520

Other trials in Finland

Netherlands2 sites

  • Brain Research Center B.V

    Amsterdam, 1081 GN

  • Erasmus Mc - Locatie Centrum; Dept of Neurology

    Rotterdam, 3015 GD

Other trials in Netherlands

Portugal2 sites

  • Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia

    Amadora, 2720-276

  • Hospital de Santa Maria; Servico de Neurologia

    Lisbon, 1649-035

Other trials in Portugal

Sweden2 sites

  • Skånes Universitetssjukhus Malmö, Minneskliniken

    Malmö, 211 46

  • KAROLINSKA UNI HOSPITAL, HUDDINGE; Mottagning Kognitiv Forskning, M54

    Stockholm, 141 86

Other trials in Sweden

Switzerland2 sites

  • Felix Platter-Spital Medizin Geriatrie

    Basel, 4002

  • CHUV Lausanne Memory clinique

    Lausanne, 1011

Other trials in Switzerland

Argentina1 site

  • Instituto Neurologia Bs As

    Ciudad Autonoma Buenos Aires, C1426ANZ

Other trials in Argentina

Hungary1 site

  • Semmelweis University; Department of Neurology

    Budapest, 1083

Other trials in Hungary

About this study

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

Part 1 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of gantenerumab in participants with mild Alzheimer disease. Participants will be randomized to receive either gantenerumab subcutaneously every 4 weeks or placebo subcutaneously every 4 weeks. Approved Alzheimer medication is allowed if on stable dose for 3 months prior to screening. Part 2 is an open-label extension (OLE).

A positron emission tomography (PET) imaging substudy will be conducted within the main study. Eligible participants who provide separate informed consent will undergo PET imaging scans using the radioligand florbetapir as a pharmacodynamic measure of changes in brain amyloid load over time.

Being tested
Placebo, Gantenerumab
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Participants received Placebo SC injection Q4W.

  • GantenerumabDrug

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

Study groups in NCT02051608
Study groupRoleWhat they receive
Part 1 (Double Blind treatment): PlaceboPlacebo comparatorParticipants received matching placebo by subcutaneous (SC) injection every 4 weeks (Q4W) up to 100 weeks during Part 1 of the study.
Receives: Drug: Placebo
Part 1 (Double Blind treatment): GantenerumabExperimentalParticipants received 105 mg Gantenerumab by SC injection Q4W for 24 weeks and if eligible 225 mg SC injection Q4W from weeks 28-100 during Part 1 of the study.
Receives: Drug: Gantenerumab
Part 2 (Open-Label Extension [OLE] treatment): Placebo switched to Gantenerumab Up to 1200 mgPlacebo comparatorParticipants who had received Placebo in Part 1, received Gantenerumab at doses up to 1200 mg by SC injection Q4W for up to 2 years. Additionally, participants were given the option to continue receiving open-label gantenerumab treatment for 3 years.
Receives: Drug: Placebo
Part 2 (OLE treatment): Gantenerumab up to 1200 mgExperimentalParticipants who had received Gantenerumab in Part 1, received treatment at doses up to 1200 mg by SC injection Q4W for up to 2 years. Additionally, participants were given the option to continue receiving open-label gantenerumab treatment for 3 years.
Receives: Drug: Gantenerumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

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

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

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

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

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

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

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

Secondary outcomes (10)

  1. Part 1: Percentage of Participants With AEs, SAEs

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

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

  2. Part 1: Percentage of Participants With Treatment Emergent ADAs

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

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

  3. Part 1: Gantenerumab Plasma Concentration at Multiple Timepoints

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

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

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

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

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

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

    Measured: Baseline (Part 1 screening), Week 104

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

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

    Measured: Baseline (Part 1 screening), Week 104

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

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

    Measured: Baseline (Part 1 screening), Week 104

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

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

    Measured: Part 2: Week 104

  9. Part 2: Gantenerumab Plasma Concentration at Multiple Timepoints

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

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

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

    Measured: Baseline, Week 156

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2014 (estimated)
  2. Study start27 Mar 2014
  3. Primary completion16 Apr 2021
  4. Study completion16 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
389 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02051608
Sponsor's protocol ID
WN28745
Other IDs
2013-003390-95
Status last verified
Feb 2023
First submitted
30 Jan 2014
Last updated
10 Feb 2023
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Neve A, Das B, Wojtowicz J, Huang Z, Bullain S, Watkin M, Lott D, Bittner T, Delmar P, Klein G, Hofmann C, Kerchner GA, Smith J, Baudler M, Fontoura P, Doody RS. Long-Term Safety of Gantenerumab in Participants with Alzheimer's Disease: A Phase III, Double-Blind, and Open-Label Extension Study (Marguerite RoAD). J Alzheimers Dis. 2024;101(1):353-367. doi: 10.3233/JAD-240221.

    PubMed 39177596

  • 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.

    PubMed 31831056

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gantenerumab in people with Alzheimer's Disease, run by Hoffmann-La Roche at 131 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 131 sites in United States, Canada, Japan, South Korea, Spain and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 2: Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) (time frame: First dose up to 4 weeks after the last dose of study drug (up to 249 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02051608, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.

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