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

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.

Study Overview

• Status: Terminated
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: Semorinemab; Drug: [18F]GTP1; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 457
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • St Vincents Medical Centre
    • Kogarah, New South Wales, Australia, 2217
      • Southern Neurology
  • Queensland
    • Mermaid Waters, Queensland, Australia, 4218
      • Queensland University of Technology
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Eastern Clinical Research Unit; Pharmacy
    • Malvern, Victoria, Australia, 3144
      • HammondCare Aged Psychiatry Clinical Trials
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital, Melbourne; Thrombosis and Haemostasis Unit
    • Noble Park, Victoria, Australia, 3174
      • Neuro Trials Victoria
    • Parkville, Victoria, Australia, 3050
      • Royal Melbourne Hospital
• Belgium
  • Brussel, Belgium, 1090
    • UZ Brussel
  • Kortrijk, Belgium, 8500
    • Az Groeninge
  • Leuven, Belgium, 3000
    • UZ Leuven
  • Roeselare, Belgium, 8800
    • AZ Delta Campus Westlaan
• Canada
  • Ontario
    • Burlington, Ontario, Canada, L7M 1K9
      • JBN Medical Diagnostic Services; Clinical Trials Division
    • London, Ontario, Canada, N6C 0A7
      • Parkwood Institute, Mental Health Care Building
    • Ottawa, Ontario, Canada, K1N 5C8
      • Elisabeth Bruyère Hospital
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital
    • Toronto, Ontario, Canada, M4N 3M5
      • Toronto Sunnybrook Hospital
    • Toronto, Ontario, Canada, M3B 2S7
      • Toronto Memory Program
    • Toronto, Ontario, Canada, M4G 3E8
      • Centre for Memory and Aging
  • Quebec
    • Gatineau, Quebec, Canada, J8T 8J1
      • Recherches Neuro-Hippocame
• Denmark
  • Aalborg, Denmark, 9000
    • Center For Clinical and Basic Research (Ccbr); Site Management Organisation
  • Vejle, Denmark, 7100
    • CCBR - Vejle - DK
• France
  • Bordeaux, France, 33076
    • Groupe Hospitalier Pellegrin; Service de Neurologie - 3ème étage
  • Bron, France, 69500
    • Hopital neurologique Pierre Wertheimer
  • Lille, France, 59037
    • Hôpital Roger Salengro
  • Marseille, France, 13005
    • CHU de la Timone - Hopital d Adultes; Service de Neurologie
  • Montpellier, France, 34295
    • Hopital Gui de Chauliac; Neurologie
  • Paris, France, 75651
    • Groupe Hospitalier Pitie-Salpetriere
  • Paris, France, 75010
    • Hopital Fernand Widal Centre
  • Rennes, France, 35033
    • CHU Rennes
  • Strasbourg, France, 67000
    • CHU Hautepierre; ACTR Association Recherche Clinique Rhumatologie
  • Strasbourg, France, 67098
    • CHU Strasbourg - Hôpital Hautepierre
  • Toulouse, France, 31059
    • Hopital de La Grave
  • Villeurbanne, France, 69100
    • Hôpital des charpennes
• Germany
  • Bayreuth, Germany, 95445
    • Klinikum Bayreuth; Krankenhaus Hohe Warte
  • Berlin, Germany, 12203
    • Charite Campus Benjamin Franklin
  • Berlin, Germany, 10245
    • Praxis Dr. med. Volker Shumann
  • Berlin, Germany, 10626
    • Studienambulanz emovis GmbH; St. Joseph Krankenhaus
  • Berlin, Germany, 13156
    • Neurologisch-psychiatrische Praxis am Brosepark
  • Günzburg, Germany, 89312
    • Bezirkskrankenhaus Günzburg
  • Hannover, Germany, 30159
    • Klinische Forschung Hannover-Mitte GmbH
  • München, Germany, 81675
    • Klinikum rechts der Isar der TU München; Klinik & Poliklinik für Neurologie
  • Siegen, Germany, 57076
    • ZNS Siegen im MVZ Weidenau
  • Tubingen, Germany, 72076
    • Universitätsklinik Tübingen; Psychiatrie und Psychotherapie
  • Ulm, Germany, 89081
    • Universitätsklinikum Ulm; Klinik für Neurologie
• Italy
  • Lazio
    • Roma, Lazio, Italy, 00185
      • Umberto I Policlinico di Roma-Università di Roma La Sapienza
    • Roma, Lazio, Italy, 00186
      • Ospedale San Giovanni Calibita Fatebenefratell;Neurologia
  • Liguria
    • Genova, Liguria, Italy, 16132
      • Azienda Ospedaliero Universitaria San Martino; Dip. di Neuroscienze Oftalmologia e Genetica
  • Lombardia
    • Brescia, Lombardia, Italy, 25125
      • IRCCS Centro San Giovanni di Dio FBF
    • Milano, Lombardia, Italy, 20133
      • Fondazione IRCCS Istituto Neurologico Carlo Besta
  • Molise
    • Pozzilli, Molise, Italy, 86077
      • IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA
  • Puglia
    • Tricase - LE, Puglia, Italy, 73039
      • Az. Osp. C. Panico; Rep. Ematologia E Trapianto
• Netherlands
  • 'S Hertogenbosch, Netherlands, 5223 GZ
    • Jeroen Bosch ziekenhuis
  • Amsterdam, Netherlands, 1081 GN
    • Brain Research Center B.V
• Poland
  • Białystok, Poland, 15-756
    • Podlaskie Centrum Psychogeriatrii
  • Bydgoszcz, Poland, 85-796
    • PALLMED Sp. z o.o. prowadząca NZOZ DOM SUE RYDER
  • Katowice, Poland, 40-595
    • M.A. - LEK A.M.Maciejowscy SC.
  • Katowice, Poland, 40-650
    • Novo-Med Zielinski i wspolnicy Sp. j.
  • Krakow, Poland, 30-510
    • Malopolskie Centrum Medyczne
  • Poznań, Poland, 61-853
    • NEURO - KARD Ośrodek Badań Klinicznych
  • Siemianowice Śląskie, Poland, 41-100
    • NEURO-CARE Sp. z o.o. Sp. Komandytowa
  • Sopot, Poland, 81-855
    • Senior Sp. Z O.O. Poradnia Psychogeriatryczna
  • Szczecin, Poland, 70-11
    • EroMedis
  • Warszawa, Poland, 01-684
    • Centrum Medyczne NeuroProtect
  • Warszawa, Poland, 01-518
    • AMED Medical Center
  • Wrocław, Poland, 53-659
    • NZOZ WCA
• Spain
  • Albacete, Spain, 2006
    • Hospital Perpetuo Socorro, Servicio de Geriatria
  • Barcelona, Spain, 08025
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain, 08036
    • Hospital Clinic i Provincial de Barcelona
  • Barcelona, Spain, 08028
    • Fundación ACE; Servicio de Neurología
  • Cordoba, Spain, 14011
    • Hospital Universitario Reina Sofia; Servicio de Neurologia
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28049
    • Hospital de Cantoblanco; Servicio de Geriatria
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe de Valencia
  • Valencia, Spain, 46017
    • Hospital Universitario Dr. Peset; Servicio de Neurologia
  • Barcelona
    • Terrassa, Barcelona, Spain, 08221
      • Hospital Mutua De Terrassa
  • Guipuzcoa
    • San Sebastian, Guipuzcoa, Spain, 20009
      • Policlinica Guipuzcoa
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universitaria de Navarra; Servicio de Neurología
  • Palencia
    • Plasencia, Palencia, Spain, 10600
      • Hospital Virgen del Puerto
  • Vizcaya
    • Barakaldo, Vizcaya, Spain, 48903
      • Hospital de Cruces; Servicio de Neurologia
• Sweden
  • Jönköping, Sweden, 551 85
    • Länssjukhuset Ryhov
  • Kalmar, Sweden, 39185
    • Länssjukhuset Kalmar; Oncology
  • Malmö, Sweden, 212 24
    • Skane University Hospital Malmo/Lund, Dept.of Hematology and Coagulation Disorders
  • Mölndal, Sweden, S-431 80
    • Sahlgrenska Univ Hospital Mölndal; Department of Nephrology
  • Stockholm, Sweden, 171 64
    • Karolinska Universitetssjukhuset Huddinge
• United Kingdom
  • Glasgow, United Kingdom, G20 0XA
    • Glasgow Memory Clinic
  • London, United Kingdom, WC1N 3BG
    • The National Hospital for Neurology & Neurosurgery
  • London, United Kingdom, W1G 9RU
    • Re:Cognition Health
  • Surrey, United Kingdom, GU2 7YD
    • Re:Cognition Health Guildford
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • University of Alabama at Birmingham
  • California
    • Glendale, California, United States, 91206
      • California Clinical Trials
    • Irvine, California, United States, 92697
      • University of California Irvine
    • Newport Beach, California, United States, 92660
      • Pharmacology Research Inst
    • Palo Alto, California, United States, 94304
      • Stanford Neuroscience Health Center (SNHC)
    • San Diego, California, United States, 92103
      • Pacific Research Network - PRN
    • Santa Monica, California, United States, 90404
      • Neurological Research Inst
    • Torrance, California, United States, 90502
      • Collaborative Neuroscience Network Inc.
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University
    • New Haven, Connecticut, United States, 06510
      • Invicro, a Konica Minolta company
    • Stamford, Connecticut, United States, 06905
      • KI Health Partners, LLC; New England Institute for Clinical Research
  • District of Columbia
    • Washington, District of Columbia, United States, 20057
      • Georgetown University Hospital
  • Florida
    • Atlantis, Florida, United States, 33462
      • JEM Research LLC
    • Bradenton, Florida, United States, 34205
      • Bradenton Research Center
    • Delray Beach, Florida, United States, 33445
      • Brain Matters Research, Inc.
    • Fort Myers, Florida, United States, 33912
      • Neuropsychiatric Research; Center of Southwest Florida
    • Miami, Florida, United States, 33137
      • Miami Jewish Health Systems
    • Naples, Florida, United States, 34105
      • Collier Neurologic Specialists
    • Orlando, Florida, United States, 32806
      • Compass Research East, LLC
    • Tampa, Florida, United States, 33613
      • Stedman Clinical Trials, LLC
    • Wellington, Florida, United States, 33414
      • Alzheimer's Research and Treatment Center
    • West Palm Beach, Florida, United States, 33407
      • Premiere Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University; Global Health
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush Alzheimer's Disease Cntr.
    • Elk Grove Village, Illinois, United States, 60007
      • Alexian Brothers Neuroscience Institute
    • Springfield, Illinois, United States, 62702
      • Southern Illinois University, School of Medicine
  • Maine
    • Bangor, Maine, United States, 04401
      • Eastern Maine Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham & Women's Hosp; TIMI Study Grp
    • Quincy, Massachusetts, United States, 02169
      • Alzheimers Disease Center
  • Minnesota
    • Saint Paul, Minnesota, United States, 55130
      • Health Partners Institute for Education and Research
  • New Jersey
    • Mount Arlington, New Jersey, United States, 07856
      • NeuroCognitive Institute
    • Toms River, New Jersey, United States, 08755
      • Advanced Memory Research Institute of NJ
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical College; Neurology
    • Latham, New York, United States, 12110
      • Empire Neurology PC; MS Center of Northeastern NY
    • New York, New York, United States, 10032
      • Columbia Univ Medical Center
    • Rochester, New York, United States, 14642
      • University of Rochester; AD-CARE
  • Oregon
    • Portland, Oregon, United States, 97210
      • Summit Research Network Inc.
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Abington Neurological Associates
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • Rhode Island Mood & Memory Research Institute
    • Providence, Rhode Island, United States, 02906
      • Butler Hospital
  • Tennessee
    • Cordova, Tennessee, United States, 38018
      • Neurology Clinic PC
    • Knoxville, Tennessee, United States, 37920
      • New Orleans Center for Clinical Research
  • Vermont
    • Bennington, Vermont, United States, 05201
      • Clinical Neuroscience Research Associates, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria

• 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

Exclusion criteria

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: [18F]GTP1; [18F]GTP1 will be administered as a solution for intravenous (IV) use, as part of positron emission tomography (PET) imaging.; Other Names: RO6880276; Drug: Placebo; Matching placebo doses of Semorinemab given intravenously (IV).
Experimental: Dose 1 Semorinemab	Drug: Semorinemab; Participants will receive Semorinemab intravenously (IV).; Other Names: RG6100; MTAU9937A; RO7105705; Drug: [18F]GTP1; [18F]GTP1 will be administered as a solution for intravenous (IV) use, as part of positron emission tomography (PET) imaging.; Other Names: RO6880276
Experimental: Dose 2 Semorinemab	Drug: Semorinemab; Participants will receive Semorinemab intravenously (IV).; Other Names: RG6100; MTAU9937A; RO7105705; Drug: [18F]GTP1; [18F]GTP1 will be administered as a solution for intravenous (IV) use, as part of positron emission tomography (PET) imaging.; Other Names: RO6880276
Experimental: Dose 3 Semorinemab	Drug: Semorinemab; Participants will receive Semorinemab intravenously (IV).; Other Names: RG6100; MTAU9937A; RO7105705; Drug: [18F]GTP1; [18F]GTP1 will be administered as a solution for intravenous (IV) use, as part of positron emission tomography (PET) imaging.; Other Names: RO6880276

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 73 Weeks
Percentage of Participants With Adverse Events	Percentage of participants with at least one adverse event	Up to the data cutoff date 15 January 2021 (up to approximately 39 months)
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.	Baseline to data cutoff date 15 January 2021 (up to approximately 39 months)
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.	Baseline, Week 9, Week 49, Week 73, Study Treatment Discontinuation, and Week 89

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 73 weeks
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.	Baseline and 73 weeks
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.	Baseline and 73 weeks
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.	Baseline and 73 weeks
Serum Concentrations of Semorinemab at Specified Timepoints	Serum concentrations of Semorinemab at specified timepoints.	Up to 109 weeks
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.	Up to 109 weeks

Collaborators and Investigators

• Sponsor: Genentech, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2017
• Primary Completion (Actual): January 15, 2021
• Study Completion (Actual): January 15, 2021

Study Registration Dates

• First Submitted: September 18, 2017
• First Submitted That Met QC Criteria: September 18, 2017
• First Posted (Actual): September 20, 2017

Study Record Updates

• Last Update Posted (Actual): March 16, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Dementia; Alzheimer Disease; Neurodegenerative Diseases; Brain Diseases; Neurocognitive Disorders
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: GN39763; 2017-001800-31 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No