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A Study to Evaluate the Efficacy and Safety of RO7105705 in Patients With Prodromal to Mild Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03289143
Recruitment Status : Active, not recruiting
First Posted : September 20, 2017
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
This is a phase II, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of RO7105705 in participants with prodromal to mild Alzheimer's disease. An optional 96-week open-label extension period will be available to participants who complete the double-blind treatment period and who, in the judgment of the investigator, would potentially benefit from open-label RO7105705 treatment.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: RO7105705 Drug: Placebo Drug: [18F]GTP1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 457 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Additional blinded personnel will include study site personnel who will evaluate participant status, contract research organization (CRO) personnel who will review case report forms (CRFs), and other sponsor agents (with the exception of the interactive voice or web-based response system [IxRS] vendor).
Primary Purpose: Treatment
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
Actual Study Start Date : October 4, 2017
Estimated Primary Completion Date : June 24, 2020
Estimated Study Completion Date : September 20, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose 1 RO7105705 Drug: RO7105705
Participants will receive RO7105705 intravenously (IV).
Other Names:
  • RG6100
  • MTAU9937A

Drug: [18F]GTP1
[18F]GTP1 will be administered as a solution for intravenous (IV) use, as part of positron emission tomography (PET) imaging.
Other Name: RO6880276

Experimental: Dose 2 RO7105705 Drug: RO7105705
Participants will receive RO7105705 intravenously (IV).
Other Names:
  • RG6100
  • MTAU9937A

Drug: [18F]GTP1
[18F]GTP1 will be administered as a solution for intravenous (IV) use, as part of positron emission tomography (PET) imaging.
Other Name: RO6880276

Experimental: Dose 3 RO7105705 Drug: RO7105705
Participants will receive RO7105705 intravenously (IV).
Other Names:
  • RG6100
  • MTAU9937A

Drug: [18F]GTP1
[18F]GTP1 will be administered as a solution for intravenous (IV) use, as part of positron emission tomography (PET) imaging.
Other Name: RO6880276

Placebo Comparator: Placebo Drug: Placebo
Matching placebo doses of RO7105705 given intravenously (IV).

Drug: [18F]GTP1
[18F]GTP1 will be administered as a solution for intravenous (IV) use, as part of positron emission tomography (PET) imaging.
Other Name: RO6880276




Primary Outcome Measures :
  1. Change from baseline on the CDR-Sum of Boxes [ Time Frame: Baseline and 73 Weeks ]
    A scale used to quantify the severity of symptoms of dementia.

  2. Percentage of Participants with Adverse Events [ Time Frame: Up to 181 weeks ]

Secondary Outcome Measures :
  1. Change From Baseline on the Repeatable Battery for Assessment of Neuropsychological Status (RBANS) [ Time Frame: Baseline and 73 weeks ]
    A scale used to quantify cognitive function across multiple domains.

  2. Change from baseline on the Alzheimer's Disease Assessment Scale−Cognitive Subscale 13 [ Time Frame: Baseline and 73 weeks ]
    A scale used to quantify the areas of cognitive function most often affected in Alzheimer's disease.

  3. Change from baseline on the Amsterdam Instrumental Activity of Daily Living questionnaire [ Time Frame: Baseline and 73 weeks ]
    A scale used to quantify performance of activities of daily living.

  4. Change from baseline on the Alzheimer's Disease Cooperative Study Group−Activities of Daily Living Inventory [ Time Frame: Baseline and 73 weeks ]
    A scale used to quantify performance of activities of daily living.

  5. Serum concentrations of RO7105705 at specified timepoints [ Time Frame: Up to 181 weeks ]
  6. Presence of anti-drug antibodies during the study relative to their presence at baseline [ Time Frame: Up to 181 weeks ]

Other Outcome Measures:
  1. Change from baseline in brain tau burden as measured by [18F]GTP1-PET [ Time Frame: Baseline and 73 weeks ]
    [18F]GTP1-PET is a brain imaging technology that allows visualization of the location and extent of tau pathology in the brain.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03289143


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Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
United States, California
California Clinical Trials
Glendale, California, United States, 91206
University of California Irvine
Irvine, California, United States, 92697
Pharmacology Research Inst
Newport Beach, California, United States, 92660
Stanford Neuroscience Health Center (SNHC)
Palo Alto, California, United States, 94304
Pacific Research Network - PRN
San Diego, California, United States, 92103
Neurological Research Inst
Santa Monica, California, United States, 90404
Collaborative Neuroscience Network Inc.
Torrance, California, United States, 90502
United States, Connecticut
Molecular NeuroImaging
New Haven, Connecticut, United States, 06510
Yale University
New Haven, Connecticut, United States, 06510
KI Health Partners, LLC; New England Institute for Clinical Research
Stamford, Connecticut, United States, 06905
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20057
United States, Florida
JEM Research LLC
Atlantis, Florida, United States, 33462
Bradenton Research Center
Bradenton, Florida, United States, 34205
Brain Matters Research, Inc.
Delray Beach, Florida, United States, 33445
Neuropsychiatric Research; Center of Southwest Florida
Fort Myers, Florida, United States, 33912
Alzheimer's Research and Treatment Center
Lake Worth, Florida, United States, 33449
Miami Jewish Health Systems
Miami, Florida, United States, 33137
Collier Neurologic Specialists
Naples, Florida, United States, 34105
Compass Research East, LLC
Orlando, Florida, United States, 32806
Stedman Clinical Trials, LLC
Tampa, Florida, United States, 33613
Premiere Research Institute
West Palm Beach, Florida, United States, 33407
United States, Georgia
Emory University; Global Health
Atlanta, Georgia, United States, 30322
United States, Illinois
Rush Alzheimer's Disease Cntr.
Chicago, Illinois, United States, 60612
Alexian Brothers Neuroscience Institute
Elk Grove Village, Illinois, United States, 60007
Southern Illinois University, School of Medicine
Springfield, Illinois, United States, 62702
United States, Maine
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
United States, Massachusetts
Brigham & Women's Hosp; TIMI Study Grp
Boston, Massachusetts, United States, 02115
Alzheimers Disease Center
Quincy, Massachusetts, United States, 02169
United States, Minnesota
Health Partners Institute for Education and Research
Saint Paul, Minnesota, United States, 55130
United States, New Jersey
NeuroCognitive Institute
Mount Arlington, New Jersey, United States, 07856
Advanced Memory Research Institute of NJ
Toms River, New Jersey, United States, 08755
United States, New York
Albany Medical College; Neurology
Albany, New York, United States, 12208
Empire Neurology PC; MS Center of Northeastern NY
Latham, New York, United States, 12110
Columbia Univ Medical Center
New York, New York, United States, 10032
University of Rochester; AD-CARE
Rochester, New York, United States, 14642
United States, Oregon
Summit Research Network Inc.
Portland, Oregon, United States, 97210
United States, Pennsylvania
Abington Neurological Associates
Willow Grove, Pennsylvania, United States, 19090
United States, Rhode Island
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, United States, 02914
Butler Hospital
Providence, Rhode Island, United States, 02906
United States, Tennessee
Neurology Clinic PC
Cordova, Tennessee, United States, 38018
New Orleans Center For Clinical Research
Knoxville, Tennessee, United States, 37920
United States, Vermont
Clinical Neuroscience Research Associates, Inc.
Bennington, Vermont, United States, 05201
Australia, New South Wales
St Vincents Medical Centre
Darlinghurst, New South Wales, Australia, 2010
Southern Neurology
Kogarah, New South Wales, Australia, 2217
Australia, Queensland
Queensland University of Technology
Mermaid Waters, Queensland, Australia, 4218
Australia, Victoria
Eastern Clinical Research Unit; Pharmacy
Box Hill, Victoria, Australia, 3128
HammondCare Aged Psychiatry Clinical Trials
Malvern, Victoria, Australia, 3144
The Alfred Hospital, Melbourne; Thrombosis and Haemostasis Unit
Melbourne, Victoria, Australia, 3004
Neuro Trials Victoria
Noble Park, Victoria, Australia, 3174
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Belgium
UZ Brussel
Brussel, Belgium, 1090
AZ Groeninge
Kortrijk, Belgium, 8500
UZ Leuven
Leuven, Belgium, 3000
AZ Delta Campus Westlaan
Roeselare, Belgium, 8800
Canada, British Columbia
Vancouver Island Health Research Centre
Victoria, British Columbia, Canada, V8R 1J8
Canada, Ontario
JBN Medical Diagnostic Services; Clinical Trials Division
Burlington, Ontario, Canada, L7M 4Y1
Parkwood Institute, Mental Health Care Building
London, Ontario, Canada, N6C 0A7
Bruyere Continuing Care
Ottawa, Ontario, Canada, K1N 5C8
Toronto Memory Program (Neurology Research Inc.)
Toronto, Ontario, Canada, M3B 2S7
The Centre for Memory and Aging
Toronto, Ontario, Canada, M4G 3E8
Toronto Sunnybrook Hospital
Toronto, Ontario, Canada, M4N3M50
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Canada, Quebec
Recherches Neuro-Hippocame
Gatineau, Quebec, Canada, J8T 8J1
Denmark
Center For Clinical and Basic Research (Ccbr); Site Management Organisation
Aalborg, Denmark, 9000
CCBR - Ballerup - DK
Ballerup, Denmark, 2750
CCBR - Vejle - DK
Vejle, Denmark, 7100
France
Groupe Hospitalier Pellegrin; Service de Neurologie - 3ème étage
Bordeaux, France, 33076
Hopital Neurologique Pierre Wertheimer
Bron, France, 69500
Hopital Roger Salengro
Lille, France, 59037
CHU de la Timone - Hopital d Adultes; Service de Neurologie
Marseille, France, 13005
Hopital Gui de Chauliac; Neurologie
Montpellier, France, 34295
Hopital Fernand Widal Centre
Paris, France, 75010
Groupe Hospitalier Pitie-Salpetriere
Paris, France, 75651
CHU Rennes - Hopital Hôtel Dieu
Rennes, France, 35064
CHU Hautepierre; ACTR Association Recherche Clinique Rhumatologie
Strasbourg, France, 67000
CHU Strasbourg - Hôpital Hautepierre
Strasbourg, France, 67098
Hopital de La Grave
Toulouse, France, 31059
Hopital des Charpennes
Villeurbanne, France, 69100
Germany
Klinikum Bayreuth; Krankenhaus Hohe Warte
Bayreuth, Germany, 95445
Praxis Dr. med. Volker Shumann
Berlin, Germany, 10245
Studienambulanz emovis GmbH; St. Joseph Krankenhaus
Berlin, Germany, 10626
Charite Campus Benjamin Franklin
Berlin, Germany, 12203
Neurologisch-psychiatrische Praxis am Brosepark
Berlin, Germany, 13156
Bezirkskrankenhaus Günzburg
Günzburg, Germany, 89312
Klinische Forschung Hannover-Mitte GmbH
Hannover, Germany, 30159
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz; Kardiologie
Mainz, Germany, 55131
Klinikum rechts der Isar der TU München; Klinik & Poliklinik für Neurologie
München, Germany, 81675
Universitätsklinikum Münster, Stabsstelle Apotheke
Münster, Germany, 48149
ZNS Siegen im MVZ Weidenau
Siegen, Germany, 57076
Universitätsklinik Tübingen; Psychiatrie und Psychotherapie
Tubingen, Germany, 72076
Universitätsklinikum Ulm; Klinik für Neurologie
Ulm, Germany, 89081
Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino; Radiology
Torino, Abruzzo, Italy, 10126
Umberto I Policlinico di Roma-Università di Roma La Sapienza
Roma, Lazio, Italy, 00185
Ospedale San Giovanni Calibita Fatebenefratell;Neurologia
Roma, Lazio, Italy, 00186
Ente Ospedaliero Ospedali Galliera; Neurologia
Genova, Liguria, Italy, 16100
Azienda Ospedaliero Universitaria San Martino; Dip. di Neuroscienze Oftalmologia e Genetica
Genova, Liguria, Italy, 16132
Asst Degli Spedali Civili Di Brescia
Brescia, Lombardia, Italy, 25100
IRCCS Centro San Giovanni di Dio FBF
Brescia, Lombardia, Italy, 25125
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milano, Lombardia, Italy, 20133
IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA
Pozzilli, Molise, Italy, 86077
Az. Osp. C. Panico; Rep. Ematologia E Trapianto
Tricase - LE, Puglia, Italy, 73039
Netherlands
Jeroen Bosch Ziekenhuis
'S Hertogenbosch, Netherlands, 5223 GZ
Brain Research Center B.V
Amsterdam, Netherlands, 1081 GN
Poland
Podlaskie Centrum Psychogeriatrii
Białystok, Poland, 15-756
PALLMED Sp. z o.o. prowadząca NZOZ DOM SUE RYDER
Bydgoszcz, Poland, 85-796
NZOZ VITO-MED Sp.z o.o.
Gliwice, Poland, 44-100
M.A. - LEK A.M.Maciejowscy SC.
Katowice, Poland, 40-595
Novo-Med Zielinski i wspolnicy Sp. j.
Katowice, Poland, 40-650
Malopolskie Centrum Medyczne
Krakow, Poland, 30-510
Samodzielny Publiczny Szpital Kliniczny Nr 4; Klinika Nefrologii
Lublin, Poland, 20- 954
NEURO - KARD Ośrodek Badań Klinicznych
Poznań, Poland, 61-853
NEURO-CARE Sp. z o.o. Sp. Komandytowa
Siemianowice Śląskie, Poland, 41-100
Senior Sp. Z O.O. Poradnia Psychogeriatryczna
Sopot, Poland, 81-855
EroMedis
Szczecin, Poland, 70-11
AMED Medical Center
Warszawa, Poland, 01-518
Centrum Medyczne NeuroProtect
Warszawa, Poland, 01-684
NZOZ WCA
Wrocław, Poland, 53-659
Spain
Hospital Mutua de Terrassa
Terrassa, Barcelona, Spain, 08221
Policlinica Guipuzcoa
San Sebastian, Guipuzcoa, Spain, 20009
Clinica Universitaria de Navarra; Servicio de Neurología
Pamplona, Navarra, Spain, 31008
Hospital Virgen del Puerto
Plasencia, Palencia, Spain, 10600
Hospital de Cruces; Servicio de Neurologia
Barakaldo, Vizcaya, Spain, 48903
Hospital Perpetuo Socorro, Servicio de Geriatria
Albacete, Spain, 2006
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Fundación ACE; Servicio de Neurología
Barcelona, Spain, 08028
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain, 08036
Hospital Universitario Reina Sofia; Servicio de Neurologia
Cordoba, Spain, 14011
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Hospital de Cantoblanco; Servicio de Geriatria
Madrid, Spain, 28049
Hospital Universitario Virgen Macarena
Sevilla, Spain, 41009
Hospital Universitario Dr. Peset; Servicio de Neurologia
Valencia, Spain, 46017
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Spain, 46026
Sweden
Länssjukhuset Ryhov
Jönköping, Sweden, 551 85
Länssjukhuset Kalmar; Oncology
Kalmar, Sweden, 39185
Skane University Hospital Malmo/Lund, Dept.of Hematology and Coagulation Disorders
Malmö, Sweden, 212 24
Sahlgrenska Univ Hospital Mölndal; Department of Nephrology
Mölndal, Sweden, S-431 80
Karolinska Universitetssjukhuset Huddinge
Stockholm, Sweden, 171 64
United Kingdom
Murray Royal Hospital; Psychiatry of Old Age (POA) Hub
Dundee, United Kingdom, DD1 9SY
Glasgow Memory Clinic
Glasgow, United Kingdom, G20 0XA
The National Hospital for Neurology & Neurosurgery
London, GT LON, United Kingdom, WC1N 3BG
RE:Cognition Health
London, United Kingdom, W1G 9RU
Charing Cross Hospital; Dept of Neurosciences
London, United Kingdom, W6 8RF
Derriford Hospital; Neurology
Plymouth, United Kingdom
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Re:Cognition Health Guildford
Surrey, United Kingdom, GU2 7YD
Victoria Centre; Kingshill Research Centre
Swindon, United Kingdom, SN3 6BW
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Genentech, Inc.

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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT03289143     History of Changes
Other Study ID Numbers: GN39763
2017-001800-31 ( EudraCT Number )
First Posted: September 20, 2017    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Genentech, Inc.:
Alzheimer Disease
Brain Diseases
Dementia
Neurodegenerative Diseases
Neurocognitive Disorders
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders