A Study to Evaluate the Efficacy and Safety of Semorinemab in Patients With Prodromal to Mild Alzheimer's Disease
NCT ID: NCT03289143
Last Updated: 2022-03-16
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
457 participants
INTERVENTIONAL
2017-10-04
2021-01-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Dose 1 Semorinemab
Semorinemab
Participants will receive Semorinemab intravenously (IV).
[18F]GTP1
\[18F\]GTP1 will be administered as a solution for intravenous (IV) use, as part of positron emission tomography (PET) imaging.
Dose 2 Semorinemab
Semorinemab
Participants will receive Semorinemab intravenously (IV).
[18F]GTP1
\[18F\]GTP1 will be administered as a solution for intravenous (IV) use, as part of positron emission tomography (PET) imaging.
Dose 3 Semorinemab
Semorinemab
Participants will receive Semorinemab intravenously (IV).
[18F]GTP1
\[18F\]GTP1 will be administered as a solution for intravenous (IV) use, as part of positron emission tomography (PET) imaging.
Placebo
Placebo
Matching placebo doses of Semorinemab given intravenously (IV).
[18F]GTP1
\[18F\]GTP1 will be administered as a solution for intravenous (IV) use, as part of positron emission tomography (PET) imaging.
Interventions
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Semorinemab
Participants will receive Semorinemab intravenously (IV).
Placebo
Matching placebo doses of Semorinemab given intravenously (IV).
[18F]GTP1
\[18F\]GTP1 will be administered as a solution for intravenous (IV) use, as part of positron emission tomography (PET) imaging.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* National Institute on Aging/Alzheimer's Association core clinical criteria for probable Alzheimer's disease (AD) dementia or mild cognitive impairment (prodromal AD)
* Evidence of the AD pathological process, by a positive amyloid assessment either on cerebrospinal fluid Aβ1-42 OR amyloid positron emission tomography (PET) scan. Historical amyloid PET scans may be accepted in some cases
* Mild AD symptomatology, as defined by a screening Mini-Mental State Examination score of \>= 20 points and Clinical Dementia Rating (CDR) -Global Score of 0.5 or 1
* Abnormal memory function at screening
* Availability of a person with sufficient contact with the participant to be able to provide accurate information on the participant's cognitive and functional ability
Exclusion Criteria
* Inability to tolerate magnetic resonance imaging (MRI) procedures or contraindication to MRI
* Contraindications to both PET imaging and lumbar dural puncture (must be able to undergo at least one of these procedures to be eligible)
* Residence in a skilled nursing facility
* Any serious medical condition or abnormality in clinical laboratory tests that remains abnormal on retest and, in the investigator's judgment, precludes the patient's safe participation in and completion of the study, or bias the assessment of the clinical or mental status of the participant to a significant degree
* Any evidence of a condition other than AD that may affect cognition
* Alcohol or substance abuse within the past 2 years
* Use of any experimental therapy within 90 days or 5 half-lives prior to screening, whichever is greater and any passive immunotherapy (immunoglobulin) against tau, except use of RO7105705 in Genentech Study GN39058, as long as the last dose was at least 90 days prior to screening
* Use of any passive immunotherapy (immunoglobulin) against Aβ, unless the last dose was at least 1 year prior to screening and any active immunotherapy (vaccine) that is under evaluation to prevent or postpone cognitive decline
* Any previous treatment with medications specifically intended to treat Parkinsonian symptoms or any other neurodegenerative disorder within 1 year of screening
* Systemic immunosuppressive therapy within 12 months of screening through the entire study period
* Typical antipsychotic or neuroleptic medication within 6 months of screening
* Daily treatment with any of the following classes of medication, except for intermittent short-term use, which is permitted except within 2 days or 5 half-lives (whichever is longer) prior to any COA: atypical antipsychotics, opiates or opioids, benzodiazepines, barbiturates, hypnotics, or any medication with clinically significant centrally-acting antihistamine or anticholinergic activity
* Stimulant medications, unless the dose has been stable within the 6 months prior to screening and is expected to be stable throughout the study
50 Years
80 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
California Clinical Trials
Glendale, California, United States
University of California Irvine
Irvine, California, United States
Pharmacology Research Inst
Newport Beach, California, United States
Stanford Neuroscience Health Center (SNHC)
Palo Alto, California, United States
Pacific Research Network - PRN
San Diego, California, United States
Neurological Research Inst
Santa Monica, California, United States
Collaborative Neuroscience Network Inc.
Torrance, California, United States
Invicro, a Konica Minolta company
New Haven, Connecticut, United States
Yale University
New Haven, Connecticut, United States
KI Health Partners, LLC; New England Institute for Clinical Research
Stamford, Connecticut, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
JEM Research LLC
Atlantis, Florida, United States
Bradenton Research Center
Bradenton, Florida, United States
Brain Matters Research, Inc.
Delray Beach, Florida, United States
Neuropsychiatric Research; Center of Southwest Florida
Fort Myers, Florida, United States
Miami Jewish Health Systems
Miami, Florida, United States
Collier Neurologic Specialists
Naples, Florida, United States
Compass Research East, LLC
Orlando, Florida, United States
Stedman Clinical Trials, LLC
Tampa, Florida, United States
Alzheimer's Research and Treatment Center
Wellington, Florida, United States
Premiere Research Institute
West Palm Beach, Florida, United States
Emory University; Global Health
Atlanta, Georgia, United States
Rush Alzheimer's Disease Cntr.
Chicago, Illinois, United States
Alexian Brothers Neuroscience Institute
Elk Grove Village, Illinois, United States
Southern Illinois University, School of Medicine
Springfield, Illinois, United States
Eastern Maine Medical Center
Bangor, Maine, United States
Brigham & Women's Hosp; TIMI Study Grp
Boston, Massachusetts, United States
Alzheimers Disease Center
Quincy, Massachusetts, United States
Health Partners Institute for Education and Research
Saint Paul, Minnesota, United States
NeuroCognitive Institute
Mount Arlington, New Jersey, United States
Advanced Memory Research Institute of NJ
Toms River, New Jersey, United States
Albany Medical College; Neurology
Albany, New York, United States
Empire Neurology PC; MS Center of Northeastern NY
Latham, New York, United States
Columbia Univ Medical Center
New York, New York, United States
University of Rochester; AD-CARE
Rochester, New York, United States
Summit Research Network Inc.
Portland, Oregon, United States
Abington Neurological Associates
Abington, Pennsylvania, United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, United States
Butler Hospital
Providence, Rhode Island, United States
Neurology Clinic PC
Cordova, Tennessee, United States
New Orleans Center For Clinical Research
Knoxville, Tennessee, United States
Clinical Neuroscience Research Associates, Inc.
Bennington, Vermont, United States
St Vincents Medical Centre
Darlinghurst, New South Wales, Australia
Southern Neurology
Kogarah, New South Wales, Australia
Queensland University of Technology
Mermaid Waters, Queensland, Australia
Eastern Clinical Research Unit; Pharmacy
Box Hill, Victoria, Australia
HammondCare Aged Psychiatry Clinical Trials
Malvern, Victoria, Australia
The Alfred Hospital, Melbourne; Thrombosis and Haemostasis Unit
Melbourne, Victoria, Australia
Neuro Trials Victoria
Noble Park, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
UZ Brussel
Brussels, , Belgium
AZ Groeninge
Kortrijk, , Belgium
UZ Leuven
Leuven, , Belgium
AZ Delta Campus Westlaan
Roeselare, , Belgium
JBN Medical Diagnostic Services; Clinical Trials Division
Burlington, Ontario, Canada
Parkwood Institute, Mental Health Care Building
London, Ontario, Canada
Elisabeth Bruyere Hospital
Ottawa, Ontario, Canada
Toronto Memory Program
Toronto, Ontario, Canada
Centre for Memory and Aging
Toronto, Ontario, Canada
Toronto Sunnybrook Hospital
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Recherches Neuro-Hippocame
Gatineau, Quebec, Canada
Center For Clinical and Basic Research (Ccbr); Site Management Organisation
Aalborg, , Denmark
CCBR - Vejle - DK
Vejle, , Denmark
Groupe Hospitalier Pellegrin; Service de Neurologie - 3ème étage
Bordeaux, , France
Hopital Neurologique Pierre Wertheimer
Bron, , France
Hopital Roger Salengro
Lille, , France
CHU de la Timone - Hopital d Adultes; Service de Neurologie
Marseille, , France
Hopital Gui de Chauliac; Neurologie
Montpellier, , France
Hopital Fernand Widal Centre
Paris, , France
Groupe Hospitalier Pitie-Salpetriere
Paris, , France
CHU Rennes
Rennes, , France
CHU Hautepierre; ACTR Association Recherche Clinique Rhumatologie
Strasbourg, , France
CHU Strasbourg - Hôpital Hautepierre
Strasbourg, , France
Hopital de La Grave
Toulouse, , France
Hopital des Charpennes
Villeurbanne, , France
Klinikum Bayreuth; Krankenhaus Hohe Warte
Bayreuth, , Germany
Praxis Dr. med. Volker Shumann
Berlin, , Germany
Studienambulanz emovis GmbH; St. Joseph Krankenhaus
Berlin, , Germany
Charite Campus Benjamin Franklin
Berlin, , Germany
Neurologisch-psychiatrische Praxis am Brosepark
Berlin, , Germany
Bezirkskrankenhaus Günzburg
Günzburg, , Germany
Klinische Forschung Hannover-Mitte GmbH
Hanover, , Germany
Klinikum rechts der Isar der TU München; Klinik & Poliklinik für Neurologie
München, , Germany
ZNS Siegen im MVZ Weidenau
Siegen, , Germany
Universitätsklinik Tübingen; Psychiatrie und Psychotherapie
Tübingen, , Germany
Universitätsklinikum Ulm; Klinik für Neurologie
Ulm, , Germany
Az. Osp. C. Panico; Rep. Ematologia E Trapianto
Tricase - LE, Apulia, Italy
Umberto I Policlinico di Roma-Università di Roma La Sapienza
Rome, Lazio, Italy
Ospedale San Giovanni Calibita Fatebenefratell;Neurologia
Rome, Lazio, Italy
Azienda Ospedaliero Universitaria San Martino; Dip. di Neuroscienze Oftalmologia e Genetica
Genoa, Liguria, Italy
IRCCS Centro San Giovanni di Dio FBF
Brescia, Lombardy, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Lombardy, Italy
IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA
Pozzilli, Molise, Italy
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, , Netherlands
Brain Research Center B.V
Amsterdam, , Netherlands
Podlaskie Centrum Psychogeriatrii
Bialystok, , Poland
PALLMED Sp. z o.o. prowadząca NZOZ DOM SUE RYDER
Bydgoszcz, , Poland
M.A. - LEK A.M.Maciejowscy SC.
Katowice, , Poland
Novo-Med Zielinski i wspolnicy Sp. j.
Katowice, , Poland
Malopolskie Centrum Medyczne
Krakow, , Poland
NEURO - KARD Ośrodek Badań Klinicznych
Poznan, , Poland
NEURO-CARE Sp. z o.o. Sp. Komandytowa
Siemianowice Śląskie, , Poland
Senior Sp. Z O.O. Poradnia Psychogeriatryczna
Sopot, , Poland
EroMedis
Szczecin, , Poland
AMED Medical Center
Warsaw, , Poland
Centrum Medyczne NeuroProtect
Warsaw, , Poland
NZOZ WCA
Wroclaw, , Poland
Hospital Mutua de Terrassa
Terrassa, Barcelona, Spain
Policlinica Guipuzcoa
Donostia / San Sebastian, Guipuzcoa, Spain
Clinica Universitaria de Navarra; Servicio de Neurología
Pamplona, Navarre, Spain
Hospital Virgen del Puerto
Plasencia, Palencia, Spain
Hospital de Cruces; Servicio de Neurologia
Barakaldo, Vizcaya, Spain
Hospital Perpetuo Socorro, Servicio de Geriatria
Albacete, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Fundación ACE; Servicio de Neurología
Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, , Spain
Hospital Universitario Reina Sofia; Servicio de Neurologia
Córdoba, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital de Cantoblanco; Servicio de Geriatria
Madrid, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario Dr. Peset; Servicio de Neurologia
Valencia, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Länssjukhuset Ryhov
Jönköping, , Sweden
Länssjukhuset Kalmar; Oncology
Kalmar, , Sweden
Skane University Hospital Malmo/Lund, Dept.of Hematology and Coagulation Disorders
Malmo, , Sweden
Sahlgrenska Univ Hospital Mölndal; Department of Nephrology
Mölndal, , Sweden
Karolinska Universitetssjukhuset Huddinge
Stockholm, , Sweden
Glasgow Memory Clinic
Glasgow, , United Kingdom
RE:Cognition Health
London, , United Kingdom
The National Hospital for Neurology & Neurosurgery
London, , United Kingdom
Re:Cognition Health Guildford
Surrey, , United Kingdom
Countries
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References
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Chandler JM, Lansdall CJ, Ye W, McDougall F, Belger M, Toth B, Mi X, Sink KM, Atkins AS. The Alzheimer's Disease Cooperative Study - Activities of Daily Living dependence score: revision and validation of an algorithm evaluating patient dependence across the spectrum of AD severity. J Prev Alzheimers Dis. 2025 Sep;12(8):100261. doi: 10.1016/j.tjpad.2025.100261. Epub 2025 Jul 1.
Schauer SP, Toth B, Lee J, Honigberg LA, Ramakrishnan V, Jiang J, Kollmorgen G, Bayfield A, Wild N, Hoffman J, Ceniceros R, Dolton M, Bohorquez SMS, Hoogenraad CC, Wildsmith KR, Teng E, Monteiro C, Anania V, Yeh FL. Pharmacodynamic effects of semorinemab on plasma and CSF biomarkers of Alzheimer's disease pathophysiology. Alzheimers Dement. 2024 Dec;20(12):8855-8866. doi: 10.1002/alz.14346. Epub 2024 Nov 8.
Sanabria Bohorquez SM, Baker S, Manser PT, Tonietto M, Galli C, Wildsmith KR, Zou Y, Kerchner GA, Weimer R, Teng E. Evaluation of partial volume correction and analysis of longitudinal [18F]GTP1 tau PET imaging in Alzheimer's disease using linear mixed-effects models. Front Neuroimaging. 2024 Mar 28;3:1355402. doi: 10.3389/fnimg.2024.1355402. eCollection 2024.
Teng E, Li Y, Manser PT, Pickthorn K, Butcher BD, Blendstrup M, Randolph C, Sikkes SAM. Cross-sectional and longitudinal assessments of function in prodromal-to-mild Alzheimer's disease: A comparison of the ADCS-ADL and A-IADL-Q scales. Alzheimers Dement (Amst). 2023 Jun 13;15(2):e12452. doi: 10.1002/dad2.12452. eCollection 2023 Apr-Jun.
Teng E, Manser PT, Shah M, Pickthorn K, Hu N, Djakovic S, Swendsen H, Blendstrup M, Faccin G, Ostrowitzki S, Sink KM. The Use of Episodic Memory Tests for Screening in Clinical Trials for Early Alzheimer's Disease: A Comparison of the Free and Cued Selective Reminding Test (FCSRT) and the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). J Prev Alzheimers Dis. 2023;10(1):41-49. doi: 10.14283/jpad.2022.101.
Teng E, Manser PT, Pickthorn K, Brunstein F, Blendstrup M, Sanabria Bohorquez S, Wildsmith KR, Toth B, Dolton M, Ramakrishnan V, Bobbala A, Sikkes SAM, Ward M, Fuji RN, Kerchner GA; Tauriel Investigators. Safety and Efficacy of Semorinemab in Individuals With Prodromal to Mild Alzheimer Disease: A Randomized Clinical Trial. JAMA Neurol. 2022 Aug 1;79(8):758-767. doi: 10.1001/jamaneurol.2022.1375.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-001800-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GN39763
Identifier Type: -
Identifier Source: org_study_id
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