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Alzheimer's DiseasePhase 2NCT03289143

A Study to Evaluate the Efficacy and Safety of Semorinemab in Patients With Prodromal to Mild Alzheimer's Disease

A Phase 2 study testing Semorinemab and [18F]GTP1 in people with Alzheimer's Disease, run by Genentech, Inc. at 133 sites in 13 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This was a phase II, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of Semorinemab in participants with prodromal to mild Alzheimer's disease. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
Semorinemab and [18F]GTP1
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
457 participants
Where
133 sitesin 13 countries
Study dates
4 Oct 2017to 15 Jan 2021
Phase
Phase 2
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 50 and 80 years
  • 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

Who cannot join

  • Pregnant or breastfeeding
  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

133 sites in 13 countries.

133 sites in 13 countries

United States43 sites

  • Abington Neurological Associates

    Abington, Pennsylvania, 19001

  • Albany Medical College; Neurology

    Albany, New York, 12208

  • Emory University; Global Health

    Atlanta, Georgia, 30322

  • JEM Research LLC

    Atlantis, Florida, 33462

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Clinical Neuroscience Research Associates, Inc.

    Bennington, Vermont, 05201

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249

  • Brigham & Women's Hosp; TIMI Study Grp

    Boston, Massachusetts, 02115

  • Bradenton Research Center

    Bradenton, Florida, 34205

  • Rush Alzheimer's Disease Cntr.

    Chicago, Illinois, 60612

  • Neurology Clinic PC

    Cordova, Tennessee, 38018

  • Brain Matters Research, Inc.

    Delray Beach, Florida, 33445

  • Rhode Island Mood & Memory Research Institute

    East Providence, Rhode Island, 02914

  • Alexian Brothers Neuroscience Institute

    Elk Grove Village, Illinois, 60007

  • Neuropsychiatric Research; Center of Southwest Florida

    Fort Myers, Florida, 33912

  • California Clinical Trials

    Glendale, California, 91206

  • University of California Irvine

    Irvine, California, 92697

  • New Orleans Center For Clinical Research

    Knoxville, Tennessee, 37920

  • Empire Neurology PC; MS Center of Northeastern NY

    Latham, New York, 12110

  • Miami Jewish Health Systems

    Miami, Florida, 33137

  • NeuroCognitive Institute

    Mount Arlington, New Jersey, 07856

  • Collier Neurologic Specialists

    Naples, Florida, 34105

  • Invicro, a Konica Minolta company

    New Haven, Connecticut, 06510

  • Yale University

    New Haven, Connecticut, 06510

  • Columbia Univ Medical Center

    New York, New York, 10032

  • Pharmacology Research Inst

    Newport Beach, California, 92660

  • Compass Research East, LLC

    Orlando, Florida, 32806

  • Stanford Neuroscience Health Center (SNHC)

    Palo Alto, California, 94304

  • Summit Research Network Inc.

    Portland, Oregon, 97210

  • Butler Hospital

    Providence, Rhode Island, 02906

  • Alzheimers Disease Center

    Quincy, Massachusetts, 02169

  • University of Rochester; AD-CARE

    Rochester, New York, 14642

  • Health Partners Institute for Education and Research

    Saint Paul, Minnesota, 55130

  • Pacific Research Network - PRN

    San Diego, California, 92103

  • Neurological Research Inst

    Santa Monica, California, 90404

  • Southern Illinois University, School of Medicine

    Springfield, Illinois, 62702

  • KI Health Partners, LLC; New England Institute for Clinical Research

    Stamford, Connecticut, 06905

  • Stedman Clinical Trials, LLC

    Tampa, Florida, 33613

  • Advanced Memory Research Institute of NJ

    Toms River, New Jersey, 08755

  • Collaborative Neuroscience Network Inc.

    Torrance, California, 90502

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20057

  • Alzheimer's Research and Treatment Center

    Wellington, Florida, 33414

  • Premiere Research Institute

    West Palm Beach, Florida, 33407

Other trials in United States

Spain15 sites

  • Hospital Perpetuo Socorro, Servicio de Geriatria

    Albacete, 2006

  • Hospital de Cruces; Servicio de Neurologia

    Barakaldo, Vizcaya, 48903

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

  • Fundación ACE; Servicio de Neurología

    Barcelona, 08028

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036

  • Hospital Universitario Reina Sofia; Servicio de Neurologia

    Córdoba, 14011

  • Policlinica Guipuzcoa

    Donostia / San Sebastian, Guipuzcoa, 20009

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital de Cantoblanco; Servicio de Geriatria

    Madrid, 28049

  • Clinica Universitaria de Navarra; Servicio de Neurología

    Pamplona, Navarre, 31008

  • Hospital Virgen del Puerto

    Plasencia, Palencia, 10600

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Mutua de Terrassa

    Terrassa, Barcelona, 08221

  • Hospital Universitario Dr. Peset; Servicio de Neurologia

    Valencia, 46017

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

Other trials in Spain

France12 sites

  • Groupe Hospitalier Pellegrin; Service de Neurologie - 3ème étage

    Bordeaux, 33076

  • Hopital Neurologique Pierre Wertheimer

    Bron, 69500

  • Hopital Roger Salengro

    Lille, 59037

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

    Marseille, 13005

  • Hopital Gui de Chauliac; Neurologie

    Montpellier, 34295

  • Hopital Fernand Widal Centre

    Paris, 75010

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, 75651

  • CHU Rennes

    Rennes, 35033

  • CHU Hautepierre; ACTR Association Recherche Clinique Rhumatologie

    Strasbourg, 67000

  • CHU Strasbourg - Hôpital Hautepierre

    Strasbourg, 67098

  • Hopital de La Grave

    Toulouse, 31059

  • Hopital des Charpennes

    Villeurbanne, 69100

Other trials in France

Poland12 sites

  • Podlaskie Centrum Psychogeriatrii

    Bialystok, 15-756

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

    Bydgoszcz, 85-796

  • M.A. - LEK A.M.Maciejowscy SC.

    Katowice, 40-595

  • Novo-Med Zielinski i wspolnicy Sp. j.

    Katowice, 40-650

  • Malopolskie Centrum Medyczne

    Krakow, 30-510

  • NEURO - KARD Ośrodek Badań Klinicznych

    Poznan, 61-853

  • NEURO-CARE Sp. z o.o. Sp. Komandytowa

    Siemianowice Śląskie, 41-100

  • Senior Sp. Z O.O. Poradnia Psychogeriatryczna

    Sopot, 81-855

  • EroMedis

    Szczecin, 70-11

  • AMED Medical Center

    Warsaw, 01-518

  • Centrum Medyczne NeuroProtect

    Warsaw, 01-684

  • NZOZ WCA

    Wroclaw, 53-659

Other trials in Poland

Germany11 sites

  • Klinikum Bayreuth; Krankenhaus Hohe Warte

    Bayreuth, 95445

  • Praxis Dr. med. Volker Shumann

    Berlin, 10245

  • Studienambulanz emovis GmbH; St. Joseph Krankenhaus

    Berlin, 10626

  • Charite Campus Benjamin Franklin

    Berlin, 12203

  • Neurologisch-psychiatrische Praxis am Brosepark

    Berlin, 13156

  • Bezirkskrankenhaus Günzburg

    Günzburg, 89312

  • Klinische Forschung Hannover-Mitte GmbH

    Hanover, 30159

  • Klinikum rechts der Isar der TU München; Klinik & Poliklinik für Neurologie

    München, 81675

  • ZNS Siegen im MVZ Weidenau

    Siegen, 57076

  • Universitätsklinik Tübingen; Psychiatrie und Psychotherapie

    Tübingen, 72076

  • Universitätsklinikum Ulm; Klinik für Neurologie

    Ulm, 89081

Other trials in Germany

Australia8 sites

  • Eastern Clinical Research Unit; Pharmacy

    Box Hill, Victoria, 3128

  • St Vincents Medical Centre

    Darlinghurst, New South Wales, 2010

  • Southern Neurology

    Kogarah, New South Wales, 2217

  • HammondCare Aged Psychiatry Clinical Trials

    Malvern, Victoria, 3144

  • The Alfred Hospital, Melbourne; Thrombosis and Haemostasis Unit

    Melbourne, Victoria, 3004

  • Queensland University of Technology

    Mermaid Waters, Queensland, 4218

  • Neuro Trials Victoria

    Noble Park, Victoria, 3174

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

Other trials in Australia

Canada8 sites

  • JBN Medical Diagnostic Services; Clinical Trials Division

    Burlington, Ontario, L7M 1K9

  • Recherches Neuro-Hippocame

    Gatineau, Quebec, J8T 8J1

  • Parkwood Institute, Mental Health Care Building

    London, Ontario, N6C 0A7

  • Elisabeth Bruyere Hospital

    Ottawa, Ontario, K1N 5C8

  • Toronto Memory Program

    Toronto, Ontario, M3B 2S7

  • Centre for Memory and Aging

    Toronto, Ontario, M4G 3E8

  • Toronto Sunnybrook Hospital

    Toronto, Ontario, M4N 3M5

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

Other trials in Canada

Italy7 sites

  • IRCCS Centro San Giovanni di Dio FBF

    Brescia, Lombardy, 25125

  • Azienda Ospedaliero Universitaria San Martino; Dip. di Neuroscienze Oftalmologia e Genetica

    Genoa, Liguria, 16132

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, Lombardy, 20133

  • IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA

    Pozzilli, Molise, 86077

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

    Rome, Lazio, 00185

  • Ospedale San Giovanni Calibita Fatebenefratell;Neurologia

    Rome, Lazio, 00186

  • Az. Osp. C. Panico; Rep. Ematologia E Trapianto

    Tricase - LE, Apulia, 73039

Other trials in Italy

Sweden5 sites

  • Länssjukhuset Ryhov

    Jönköping, 551 85

  • Länssjukhuset Kalmar; Oncology

    Kalmar, 39185

  • Skane University Hospital Malmo/Lund, Dept.of Hematology and Coagulation Disorders

    Malmö, 212 24

  • Sahlgrenska Univ Hospital Mölndal; Department of Nephrology

    Mölndal, S-431 80

  • Karolinska Universitetssjukhuset Huddinge

    Stockholm, 171 64

Other trials in Sweden

Belgium4 sites

  • UZ Brussel

    Brussels, 1090

  • AZ Groeninge

    Kortrijk, 8500

  • UZ Leuven

    Leuven, 3000

  • AZ Delta Campus Westlaan

    Roeselare, 8800

Other trials in Belgium

United Kingdom4 sites

  • Glasgow Memory Clinic

    Glasgow, G20 0XA

  • RE:Cognition Health

    London, W1G 9RU

  • The National Hospital for Neurology & Neurosurgery

    London, WC1N 3BG

  • Re:Cognition Health Guildford

    Surrey, GU2 7YD

Other trials in United Kingdom

Denmark2 sites

  • Center For Clinical and Basic Research (Ccbr); Site Management Organisation

    Aalborg, 9000

  • CCBR - Vejle - DK

    Vejle, 7100

Other trials in Denmark

Netherlands2 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5223 GZ

  • Brain Research Center B.V

    Amsterdam, 1081 GN

Other trials in Netherlands

About this study

Official title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of MTAU9937A in Patients With Prodromal to Mild Alzheimer's Disease

This was a phase II, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of Semorinemab in participants with prodromal to mild Alzheimer's disease. An optional 96-week open-label extension period was available to participants who completed the double-blind treatment period and who, in the judgment of the investigator, would potentially benefit from open-label Semorinemab treatment.

Being tested
Semorinemab, Placebo, [18F]GTP1
Keywords
Alzheimer Disease, Brain Diseases, Dementia, Neurodegenerative Diseases, Neurocognitive Disorders
Medical subject headings
Alzheimer Disease, Brain Diseases, Dementia, Neurodegenerative Diseases, Neurocognitive Disorders

What participants receive

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

  • SemorinemabDrug

    Also called RG6100, MTAU9937A, RO7105705

    Participants will receive Semorinemab intravenously (IV).

  • PlaceboDrug

    Matching placebo doses of Semorinemab given intravenously (IV).

  • [18F]GTP1Drug

    Also called RO6880276

    [18F]GTP1 will be administered as a solution for intravenous (IV) use, as part of positron emission tomography (PET) imaging.

Study groups in NCT03289143
Study groupRoleWhat they receive
Dose 1 SemorinemabExperimentalNot described
Receives: Drug: Semorinemab; Drug: [18F]GTP1
Dose 2 SemorinemabExperimentalNot described
Receives: Drug: Semorinemab; Drug: [18F]GTP1
Dose 3 SemorinemabExperimentalNot described
Receives: Drug: Semorinemab; Drug: [18F]GTP1
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo; Drug: [18F]GTP1

What is being measured

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

  1. Change From Baseline on the CDR-SB

    The Clinical Dementia Rating-Sum of Boxes (CDR-SB) 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 no impairment = 0, questionable impairment = 0.5 and mild, moderate and severe impairment = 1, 2 and 3 respectively. The score range is from 0 to 18 with a high score indicating a high disease severity. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.

    Measured: Baseline and 73 Weeks

  2. Percentage of Participants With Adverse Events

    Percentage of participants with at least one adverse event

    Measured: Up to the data cutoff date 15 January 2021 (up to approximately 39 months)

  3. Change From Baseline on the C-SSRS

    Categories are as defined in the Classification Algorithm for Suicide Assessment (CASA) based on the Columbia Suicide Severity Rating Scale (C-SSRS) questionnaire. SI1: Passive category is "Wish to be dead", SI2: Active-Nonspecific (no method, intent or plan), SI3: Active-Method, but no intent or Plan, SI4: Active-Method and intent, but no plan in C-SSRS. The worst post-baseline suicidal ideation is the highest across post-baseline visits, with highest as SI5 and lowest as SI1. Percentages are based on the total number of subjects in a treatment group. Baseline is the last observation prior to initiation of study drug.

    Measured: Baseline to data cutoff date 15 January 2021 (up to approximately 39 months)

  4. Other Abnormal MRI Findings

    Other abnormal MRI findings by visit. For the Double Blind Period, baseline is defined as last results prior to initiation of study drug. For the Open Label Extension Period, baseline is defined as last results prior to entering the open label period.

    Measured: Baseline, Week 9, Week 49, Week 73, Study Treatment Discontinuation, and Week 89

Secondary outcomes (6)

  1. Change From Baseline on the Repeatable Battery for Assessment of Neuropsychological Status (RBANS)

    The RBANS is a validated neuropsychological assessment has been shown to be a useful tool in both clinical and research settings. The RBANS consists of ten subtests that are combined to provide five indices, one for each of the five domains tested (immediate memory, visuospatial/constructional, language, attention, and delayed memory). Scores range from 40 to 160 and a higher score indicates better cognitive functioning. A decrease in the outcome measure from baseline corresponds to disease worsening. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.

    Measured: Baseline and 73 weeks

  2. Change From Baseline on the Alzheimer's Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog-13) Subscale Score

    The ADAS-Cog-13 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 ADAS-Cog-13 is the ADAS-Cog-11 with 2 further items: delayed word recall and total digit cancellation. The score range for ADAS-Cog-13 is from 0 to 85 with high scores representing severe dysfunction. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.

    Measured: Baseline and 73 weeks

  3. Change From Baseline on the Amsterdam Instrumental Activity of Daily Living (iADL) Questionnaire

    The Amsterdam iADL questionnaire is an informant-based instrument for measuring iADL problems in participants with dementia. This instrument consists of 70 items, scored on a 5-point scale, that uses item response theory for scoring. Items presented to the informant are tailored to responses to earlier items; thus each administration of the Amsterdam iADL may consist of less than the total of 70 items. The resulting score ranges from 20 to 80 with lower scores indicating poorer performance. A decrease in the outcome measure from baseline corresponds to disease worsening. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.

    Measured: Baseline and 73 weeks

  4. Change From Baseline on the Alzheimer's Disease Cooperative Study Group-Activities of Daily Living Inventory

    The ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living) is the scale most widely used to assess functional outcomes in participants with AD. The ADCS-ADL covers both basic ADL (e.g., eating and toileting) and more complex 'instrumental' ADL or iADL (e.g., using the telephone, managing finances and preparing a meal). The ADCS-ADL consists of 23 questions with a score range of 0 to 78 where a higher score represents better function. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.

    Measured: Baseline and 73 weeks

  5. Serum Concentrations of Semorinemab at Specified Timepoints

    Serum concentrations of Semorinemab at specified timepoints.

    Measured: Up to 109 weeks

  6. Presence of Anti-drug Antibodies During the Study Relative to Their Presence at Baseline

    Presence of anti-drug antibodies during the study relative to their presence at baseline.

    Measured: Up to 109 weeks

Timeline

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

  1. First posted20 Sep 2017
  2. Study start4 Oct 2017
  3. Primary completion15 Jan 2021
  4. Study completion15 Jan 2021

Why it stopped: Study was terminated during Open Label Extension period because analyses of placebo-controlled Blinded portion of study did not show any evidence of clinical efficacy or modulation of accumulation of tau PET signal at any of the doses studied.

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
457 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03289143
Sponsor's protocol ID
GN39763
Other IDs
2017-001800-31, 2017
Status last verified
Feb 2022
First submitted
18 Sep 2017
Last updated
16 Mar 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 40603145

  • 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.

    PubMed 39513754

  • Ramakrishnan V, Bender B, Langenhorst J, Magnusson MO, Dolton M, Shim J, Fuji RN, Monteiro C, Teng E, Kassir N, Jin J. Semorinemab Pharmacokinetics and The Effect on Plasma Total Tau Pharmacodynamics in Clinical Studies. J Prev Alzheimers Dis. 2024;11(5):1241-1250. doi: 10.14283/jpad.2024.146.

    PubMed 39350369

  • 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.

    PubMed 38606196

  • 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.

    PubMed 37325545

  • 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.

    PubMed 36641609

  • 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.

    PubMed 35696185

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Semorinemab and [18F]GTP1 in people with Alzheimer's Disease, run by Genentech, Inc. at 133 sites in 13 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 6 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: stopped early, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 133 sites in United States, Spain, France, Poland, Germany and 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Mar 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?

Change From Baseline on the CDR-SB (time frame: Baseline and 73 Weeks). The study lists 4 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 NCT03289143, which also lists 7 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 16 Mar 2022.

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