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

NCT01224106 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: WN252032010-019895-66
• Study Type: interventional
• Target: 799
• Locations: 24 countries
• Sites: 139

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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, Week 104

• 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.

  Baseline up until a maximum of 5 years

Secondary Outcomes (26)

• Mean Change From Baseline in Alzheimer Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog-11) Scores at Week 104 (Double-Blind Treatment Phase)

  Baseline, Week 104

• Time to Onset of Dementia at Week 104 (Double-Blind Treatment Phase)

  Baseline, Week 104

• Mean Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Composite Score at Week 104 (Double-Blind Treatment Phase)

  Baseline, Week 104

• Mean Change From Baseline in Free and Cued Selective Reminding Test (FCSRT) Score at Week 104 (Double-Blind Treatment Phase)

  Baseline, Week 104

• Mean Change From Baseline in Functional Activities Questionnaire (FAQ) Score at Week 104 (Double-Blind Treatment Phase)

  Baseline, Week 104

Study Arms (5)

Placebo (Parts 1 and 2)

PLACEBO COMPARATOR

Participants with Alzheimer's disease received Placebo by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2.

Drug: Placebo

Gantenerumab 105 mg (Parts 1 and 2)

EXPERIMENTAL

Participants with Alzheimer's disease received Gantenerumab 105 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2.

Drug: Gantenerumab

Gantenerumab 225 mg (Parts 1 and 2)

EXPERIMENTAL

Participants with Alzheimer's disease received Gantenerumab 225 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2.

Drug: Gantenerumab

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

PLACEBO COMPARATOR

Participants with Alzheimer's disease who had received Placebo by SC injection in Part 1 or Part 2, now received Gantenerumab at doses up to 1200 mg by SC injection every 4 weeks (Q4W) for up to 5 additional years.

Drug: Gantenerumab

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

EXPERIMENTAL

Participants with Alzheimer's disease who had received Gantenerumab by SC injection in Part 1 or Part 2, now received Gantenerumab at doses up to 1200 mg by SC injection every 4 weeks (Q4W) for up to 5 additional years.

Drug: Gantenerumab

Interventions

Gantenerumab DRUG

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

Gantenerumab 105 mg (Parts 1 and 2); Gantenerumab 225 mg (Parts 1 and 2); Gantenerumab Up to 1200 mg (Part 3 Open-Label Extension [OLE]); Placebo (Parts 1 and 2) switched to Gantenerumab Up to 1200mg (Part 3 Open-Label Extension [OLE])

Placebo DRUG

Participants received Placebo SC injection Q4W.

Placebo (Parts 1 and 2)

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (139)

Banner Alzheimer's Institute

Phoenix, Arizona, 85006, United States

Location

University of California, San Diego

La Jolla, California, 92037, United States

Location

Yale University ADRU

New Haven, Connecticut, 06510, United States

Location

Brain Matters Research, Inc.

Delray Beach, Florida, 33445, United States

Location

Infinity Clinical Research

Hollywood, Florida, 33024, United States

Location

Accelerated Enrollment Solutions

Orlando, Florida, 32806, United States

Location

Roskamp Institute, Inc.

Sarasota, Florida, 34243, United States

Location

Compass Research

The Villages, Florida, 32162, United States

Location

Premiere Research Institute

West Palm Beach, Florida, 33407, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Boston Center for Memory

Newton, Massachusetts, 02459, United States

Location

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

Kalamazoo, Michigan, 49008, United States

Location

Neurological Research Center

Hattiesburg, Mississippi, 39401, United States

Location

Princeton Medical Institute

Princeton, New Jersey, 08540, United States

Location

Nathan Kline Institute

Orangeburg, New York, 10962, United States

Location

University of Rochester Medical Center; Monroe Community Hospital

Rochester, New York, 14627, United States

Location

Alzheimer's Memory Center

Matthews, North Carolina, 28105, United States

Location

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

Portland, Oregon, 97239, United States

Location

Northeastern Pennsylvania Memory

Plains, Pennsylvania, 18705, United States

Location

Rhode Island Mood & Memory Research Institute

East Providence, Rhode Island, 02914, United States

Location

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Senior Adults Specialty Research

Austin, Texas, 78757, United States

Location

Texas Neurology PA

Dallas, Texas, 75206, United States

Location

Clinical Neuroscience Research Associates, Inc.

Bennington, Vermont, 05201, United States

Location

Hospital Italiano

Buenos Aires, C1181ACH, Argentina

Location

IME - Instituto Médico Especializado; Ensayos Clínicos

Buenos Aires, C1405BCH, Argentina

Location

ALPI-Inst. de Rehabilitacion Marcelo Fitte

Buenos Aires, C1425BWO, Argentina

Location

CEMIC

Buenos Aires, C1431FWO, Argentina

Location

Mulieris

CABA, C1022AAO, Argentina

Location

Instituto De Neurología Cognitiva - INECO

Caba, C1126AAB, Argentina

Location

FLENI

CABA, C1428AQK, Argentina

Location

Instituto Kremer

Córdoba, X5004AOA, Argentina

Location

CENPIA; Neurología - Psicología

La Plata, B1902AJU, Argentina

Location

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

Hornsby, New South Wales, 2077, Australia

Location

Prince of Wales Hospital, Academic Department for Old Age Psychiatry

Randwick, New South Wales, 2031, Australia

Location

Royal Adelaide Hospital; Memory Trials Centre

Adelaide, South Australia, 5000, Australia

Location

The Queen Elizabeth Hospital; Neurology

Woodville, South Australia, 5011, Australia

Location

Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre

Heidelberg West, Victoria, 3081, Australia

Location

Australian Alzheimer's Research Foundation

Nedlands, Western Australia, 6009, Australia

Location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

Hospital das Clinicas - UFPR; Ciencias da Saude

Curitiba, Paraná, 80060-900, Brazil

Location

Hospital das Clinicas - UFRGS

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Hospital Mae de Deus

Porto Alegre, Rio Grande do Sul, 90470-340, Brazil

Location

Universidade Federal de Sao Paulo - UNIFESPX; Neurologia

São Paulo, São Paulo, 04024-002, Brazil

Location

Hospital das Clinicas - FMUSP; Psiquiatria

São Paulo, São Paulo, 05403-010, Brazil

Location

True North Clinical Research

New Minas, Nova Scotia, B4N 3R7, Canada

Location

Kawartha Centre - Redefining Healthy Aging

Peterborough, Ontario, K9H 2P4, Canada

Location

Toronto Memory Program

Toronto, Ontario, M3B 2S7, Canada

Location

Centre for Memory and Aging

Toronto, Ontario, M4G 3E8, Canada

Location

NeuroSearch Developpements inc

Greenfield Park, Quebec, J4V 2J2, Canada

Location

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

Montreal, Quebec, H3T 1E2, Canada

Location

CHAUQ - Hôpital Enfant-Jésus

Québec, Quebec, G1J 1Z4, Canada

Location

Biomedica Research Group

Santiago, 7500710, Chile

Location

Especialidades Medicas LYS

Santiago, 7560356, Chile

Location

St. Anne´s University Hospital; Clinical Trials Department

Brno, 656 91, Czechia

Location

Vestra Clinics s.r.o.

Rychnov nad Kněžnou, 516 01, Czechia

Location

Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken

Aarhus N, 8200, Denmark

Location

Rigshospitalet, Hukommelsesklinikken

Koebenhavn Oe, 2100, Denmark

Location

CRST Oy

Turku, 20520, Finland

Location

Hopital Avicenne; Neurologie

Bobigny, 93009, France

Location

Hopital Pellegrin; Cmrr Aquitaine

Bordeaux, 33076, France

Location

Hopital Pierre Wertheimer; Laboratoire De Neuro Psychologie

Bron, 69677, France

Location

CHU De Caen; Service De Neurologie Dejerine

Caen, 14033, France

Location

Hopital B Roger Salengro; Cmrr Lille

Lille, 59037, France

Location

Ch Pitie Salpetriere; Cmrr Ile De France Salpetriere

Paris, 75651, France

Location

CHU de Rouen Hopital; Service de Neurologie

Rouen, 76031, France

Location

Hop Guillaume Et Rene Laennec; Cmrr St Herblain

Saint-Herblain, 44800, France

Location

Hopital Hautepierre; Centre dInvestigation Clinique

Strasbourg, 67098, France

Location

Hopital de La Grave

Toulouse, 31059, France

Location

Univ Berlin; Klin fur Psychi & Psycho Charite

Berlin, 12203, Germany

Location

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

Bonn, 53127, Germany

Location

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

Frankfurt, 60528, Germany

Location

PANAKEIA - Arzneimittelforschung Leipzig GmbH

Leipzig, 04275, Germany

Location

Zentralinstitut für Seelische Gesundheit Abt.Gerontopsychiatrie

Mannheim, 68159, Germany

Location

Pharmakologisches Studienzentrum

Mittweida, 09648, Germany

Location

Neurologische Praxis Dr. Andrej Pauls

München, 80331, Germany

Location

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

München, 81675, Germany

Location

Office of Dr Klaus Steinwachs Neurology & Psychiatry

Nuremberg, 90402, Germany

Location

Universitätsklinikum Rostock Zentrum für Nervenheilkunde

Rostock, 18147, Germany

Location

Universitätsklinikum Ulm; Klinik für Neurologie

Ulm, 89081, Germany

Location

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

Modena, Emilia-Romagna, 41126, Italy

Location

Universita' Di Parma Istituto Neurologia

Parma, Emilia-Romagna, 43126, Italy

Location

Azienda Ospedaliera Spedali Civili; Scienze Neurologiche

Brescia, Lombardy, 25100, Italy

Location

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

Brescia, Lombardy, 25125, Italy

Location

Irccs Multimedica Santa Maria; Unita' Di Neurologia

Castellanza, Lombardy, 21053, Italy

Location

Fondazione San Raffaele Del Monte Tabor; Dipartimento Di Neurologia

Milan, Lombardy, 20132, Italy

Location

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

Torrette - Ancona, The Marches, 60100, Italy

Location

Uni Di Firenze Dip. Scienze Neurol Psic Sod Neurologia 1

Florence, Tuscany, 50134, Italy

Location

Hospital Mexico Americano

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

Location

Hospital Universitario; Dr. Jose E. Gonzalez

Monterrey, Nuevo León, 64460, Mexico

Location

Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC

Culiacán, 80020, Mexico

Location

Unidad de Investigacion en Enfermedades Cronico-Degenerativa; Reumatologia

Guadalajara, 44620, Mexico

Location

Estimulacion Magnetica Trnscraneal de Mexico SC.

Mexico City, 11000, Mexico

Location

Centro Medico San Francisco; Geriatrics

Monterrey, 64710, Mexico

Location

Hospital Universitario de Saltillo

Saltillo, 25000, Mexico

Location

Jeroen Bosch Ziekenhuis; Polikliniek Geriatrie

's-Hertogenbosch, 5223 GZ, Netherlands

Location

Brain Research Center B.V

Amsterdam, 1081 GN, Netherlands

Location

Podlaskie Centrum Psychogeriatrii

Bialystok, 15-756, Poland

Location

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

Bydgoszcz, 85-796, Poland

Location

NEURO - KARD Ośrodek Badań Klinicznych

Poznan, 61-853, Poland

Location

Przychodnia Specjalistyczna PROSEN

Warsaw, 01-231, Poland

Location

mMED Maciej Czarnecki

Warsaw, 01-684, Poland

Location

Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia

Amadora, 2720-276, Portugal

Location

Hospital de Santa Maria; Servico de Neurologia

Lisbon, 1649-035, Portugal

Location

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

Kazan', 420101, Russia

Location

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

Saint Petersburg, 190103, Russia

Location

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

Saint Petersburg, 194044, Russia

Location

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

Saratov, 410028, Russia

Location

Sverdlovsk Regional Clinical Psychoneurological War Veteran Hospital

Yekaterinburg, 620036, Russia

Location

Seoul National University Bundang Hospital; Neurology Department

Gyeonggi-do, 13620, South Korea

Location

Konkuk University Medical Center

Seoul, 05030, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Seoul St Mary's Hospital

Seoul, 06591, South Korea

Location

Asan Medical Center.

Seoul, 138-736, South Korea

Location

Fundació ACE

BArcelon, Barcelona, 08034, Spain

Location

Hospital Mutua De Terrasa; Servicio de Neurologia

Terrassa, Barcelona, 08222, Spain

Location

Hospital de Cruces; Servicio de Neurologia

Barakaldo, Vizcaya, 48903, Spain

Location

Hospital del Mar; Servicio de Neurologia

Barcelona, 08003, Spain

Location

Hospital Clinic i Provincial; Servicio de Neurologia

Barcelona, 08036, Spain

Location

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

Barcelona, 08041, Spain

Location

Hospital Ramon y Cajal; Servicio de Neurologia

Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre; Servicio de Neurologia

Madrid, 28041, Spain

Location

Hospital Universitario La Paz; Servicio de Neurologia

Madrid, 28046, Spain

Location

Hospital Universitario Dr. Peset; Servicio de Neurologia

Valencia, 46017, Spain

Location

Skånes Universitetssjukhus Malmö, Minneskliniken

Malmo, 211 46, Sweden

Location

Felix Platter-Spital Medizin Geriatrie

Basel, 4002, Switzerland

Location

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

Chêne-Bourg, 1225, Switzerland

Location

Akdeniz University School of Medicine, Neurology Department

Antalya, 07058, Turkey (Türkiye)

Location

Istanbul University Istanbul School of Medicine; Neurology

Istanbul, 34093, Turkey (Türkiye)

Location

Ondokuz Mayis University School of Medicine; Neurology

Samsun, 55239, Turkey (Türkiye)

Location

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

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

Cardiff, CF64 2XX, United Kingdom

Location

St Margaret's Hospital

Epping, CM16 6TN, United Kingdom

Location

Glasgow Memory Clinic

Glasgow, G20 0XA, United Kingdom

Location

Charing Cross Hospital; Dept of Neurosciences

London, W6 8RF, United Kingdom

Location

Campus for Ageing & Vitality; Clincal Ageing Research Unit

Newcastle, NE4 5PL, United Kingdom

Location

Moorgreen Hospital; Memory Assessment & Rsch Ctr

Southampton, SO30 3JB, United Kingdom

Location

Victoria Centre; Kingshill Research Centre

Swindon, SN3 6BW, United Kingdom

Location

Hollins Park Hospital

Warrington, WA2 8WA, United Kingdom

Location

Related Publications (4)

• Boada M, 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, open-label extension study (SCarlet RoAD). J Alzheimers Dis. 2025 Jan;103(2):528-541. doi: 10.1177/13872877241303644. Epub 2024 Dec 16.

  PMID: 39686620 DERIVED

• 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.

  PMID: 31831056 DERIVED

• 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.

  PMID: 29221491 DERIVED

• 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.

  PMID: 22583155 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

gantenerumab

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 19, 2010
• Study Start: November 30, 2010
• Primary Completion: September 10, 2020
• Study Completion: September 10, 2020
• Last Updated: December 13, 2021
• Results First Posted: December 13, 2021

Record last verified: 2021-12

Locations

SE (1); TU (3); NL (2); CA (7); CL (2); PT (2); ME (7); DK (2); FI (1); RU (5); KR (5); IT (8); ES (10); AU (6); BE (1); CZ (2); BR (5); US (24); FR (10); DE (11); CH (2); GB (9); PL (5); AR (9)