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

Primary Purpose

Alzheimer's Disease

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Semorinemab
Placebo
[18F]GTP1
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer Disease, Brain Diseases, Dementia, Neurodegenerative Diseases, Neurocognitive Disorders

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • California Clinical Trials
  • University of California Irvine
  • Pharmacology Research Inst
  • Stanford Neuroscience Health Center (SNHC)
  • Pacific Research Network - PRN
  • Neurological Research Inst
  • Collaborative Neuroscience Network Inc.
  • Invicro, a Konica Minolta company
  • Yale University
  • KI Health Partners, LLC; New England Institute for Clinical Research
  • Georgetown University Hospital
  • JEM Research LLC
  • Bradenton Research Center
  • Brain Matters Research, Inc.
  • Neuropsychiatric Research; Center of Southwest Florida
  • Miami Jewish Health Systems
  • Collier Neurologic Specialists
  • Compass Research East, LLC
  • Stedman Clinical Trials, LLC
  • Alzheimer's Research and Treatment Center
  • Premiere Research Institute
  • Emory University; Global Health
  • Rush Alzheimer's Disease Cntr.
  • Alexian Brothers Neuroscience Institute
  • Southern Illinois University, School of Medicine
  • Eastern Maine Medical Center
  • Brigham & Women's Hosp; TIMI Study Grp
  • Alzheimers Disease Center
  • Health Partners Institute for Education and Research
  • NeuroCognitive Institute
  • Advanced Memory Research Institute of NJ
  • Albany Medical College; Neurology
  • Empire Neurology PC; MS Center of Northeastern NY
  • Columbia Univ Medical Center
  • University of Rochester; AD-CARE
  • Summit Research Network Inc.
  • Abington Neurological Associates
  • Rhode Island Mood & Memory Research Institute
  • Butler Hospital
  • Neurology Clinic PC
  • New Orleans Center For Clinical Research
  • Clinical Neuroscience Research Associates, Inc.
  • St Vincents Medical Centre
  • Southern Neurology
  • Queensland University of Technology
  • Eastern Clinical Research Unit; Pharmacy
  • HammondCare Aged Psychiatry Clinical Trials
  • The Alfred Hospital, Melbourne; Thrombosis and Haemostasis Unit
  • Neuro Trials Victoria
  • Royal Melbourne Hospital
  • UZ Brussel
  • AZ Groeninge
  • UZ Leuven
  • AZ Delta Campus Westlaan
  • JBN Medical Diagnostic Services; Clinical Trials Division
  • Parkwood Institute, Mental Health Care Building
  • Elisabeth Bruyere Hospital
  • Toronto Memory Program
  • Centre for Memory and Aging
  • Toronto Sunnybrook Hospital
  • Toronto Western Hospital
  • Recherches Neuro-Hippocame
  • Center For Clinical and Basic Research (Ccbr); Site Management Organisation
  • CCBR - Vejle - DK
  • Groupe Hospitalier Pellegrin; Service de Neurologie - 3ème étage
  • Hopital Neurologique Pierre Wertheimer
  • Hopital Roger Salengro
  • CHU de la Timone - Hopital d Adultes; Service de Neurologie
  • Hopital Gui de Chauliac; Neurologie
  • Hopital Fernand Widal Centre
  • Groupe Hospitalier Pitie-Salpetriere
  • CHU Rennes
  • CHU Hautepierre; ACTR Association Recherche Clinique Rhumatologie
  • CHU Strasbourg - Hôpital Hautepierre
  • Hopital de La Grave
  • Hopital des Charpennes
  • Klinikum Bayreuth; Krankenhaus Hohe Warte
  • Praxis Dr. med. Volker Shumann
  • Studienambulanz emovis GmbH; St. Joseph Krankenhaus
  • Charite Campus Benjamin Franklin
  • Neurologisch-psychiatrische Praxis am Brosepark
  • Bezirkskrankenhaus Günzburg
  • Klinische Forschung Hannover-Mitte GmbH
  • Klinikum rechts der Isar der TU München; Klinik & Poliklinik für Neurologie
  • ZNS Siegen im MVZ Weidenau
  • Universitätsklinik Tübingen; Psychiatrie und Psychotherapie
  • Universitätsklinikum Ulm; Klinik für Neurologie
  • Umberto I Policlinico di Roma-Università di Roma La Sapienza
  • Ospedale San Giovanni Calibita Fatebenefratell;Neurologia
  • Azienda Ospedaliero Universitaria San Martino; Dip. di Neuroscienze Oftalmologia e Genetica
  • IRCCS Centro San Giovanni di Dio FBF
  • Fondazione IRCCS Istituto Neurologico Carlo Besta
  • IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA
  • Az. Osp. C. Panico; Rep. Ematologia E Trapianto
  • Jeroen Bosch Ziekenhuis
  • Brain Research Center B.V
  • Podlaskie Centrum Psychogeriatrii
  • PALLMED Sp. z o.o. prowadząca NZOZ DOM SUE RYDER
  • M.A. - LEK A.M.Maciejowscy SC.
  • Novo-Med Zielinski i wspolnicy Sp. j.
  • Malopolskie Centrum Medyczne
  • NEURO - KARD Ośrodek Badań Klinicznych
  • NEURO-CARE Sp. z o.o. Sp. Komandytowa
  • Senior Sp. Z O.O. Poradnia Psychogeriatryczna
  • EroMedis
  • AMED Medical Center
  • Centrum Medyczne NeuroProtect
  • NZOZ WCA
  • Hospital Mutua de Terrassa
  • Policlinica Guipuzcoa
  • Clinica Universitaria de Navarra; Servicio de Neurología
  • Hospital Virgen del Puerto
  • Hospital de Cruces; Servicio de Neurologia
  • Hospital Perpetuo Socorro, Servicio de Geriatria
  • Hospital de la Santa Creu i Sant Pau
  • Fundación ACE; Servicio de Neurología
  • Hospital Clinic i Provincial de Barcelona
  • Hospital Universitario Reina Sofia; Servicio de Neurologia
  • Hospital Universitario Ramon y Cajal
  • Hospital de Cantoblanco; Servicio de Geriatria
  • Hospital Universitario Virgen Macarena
  • Hospital Universitario Dr. Peset; Servicio de Neurologia
  • Hospital Universitari i Politecnic La Fe de Valencia
  • Länssjukhuset Ryhov
  • Länssjukhuset Kalmar; Oncology
  • Skane University Hospital Malmo/Lund, Dept.of Hematology and Coagulation Disorders
  • Sahlgrenska Univ Hospital Mölndal; Department of Nephrology
  • Karolinska Universitetssjukhuset Huddinge
  • Glasgow Memory Clinic
  • RE:Cognition Health
  • The National Hospital for Neurology & Neurosurgery
  • Re:Cognition Health Guildford

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Dose 1 Semorinemab

Dose 2 Semorinemab

Dose 3 Semorinemab

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.
Percentage of Participants With Adverse Events
Percentage of participants with at least one adverse event
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
Serum Concentrations of Semorinemab at Specified Timepoints
Serum concentrations of Semorinemab at specified timepoints.
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.

Full Information

First Posted
September 18, 2017
Last Updated
February 16, 2022
Sponsor
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03289143
Brief Title
A Study to Evaluate the Efficacy and Safety of Semorinemab in Patients With Prodromal to Mild Alzheimer's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why 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.
Study Start Date
October 4, 2017 (Actual)
Primary Completion Date
January 15, 2021 (Actual)
Study Completion Date
January 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer Disease, Brain Diseases, Dementia, Neurodegenerative Diseases, Neurocognitive Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes 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).
Allocation
Randomized
Enrollment
457 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose 1 Semorinemab
Arm Type
Experimental
Arm Title
Dose 2 Semorinemab
Arm Type
Experimental
Arm Title
Dose 3 Semorinemab
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Semorinemab
Other Intervention Name(s)
RG6100, MTAU9937A, RO7105705
Intervention Description
Participants will receive Semorinemab intravenously (IV).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo doses of Semorinemab given intravenously (IV).
Intervention Type
Drug
Intervention Name(s)
[18F]GTP1
Other Intervention Name(s)
RO6880276
Intervention Description
[18F]GTP1 will be administered as a solution for intravenous (IV) use, as part of positron emission tomography (PET) imaging.
Primary Outcome Measure Information:
Title
Change From Baseline on the CDR-SB
Description
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.
Time Frame
Baseline and 73 Weeks
Title
Percentage of Participants With Adverse Events
Description
Percentage of participants with at least one adverse event
Time Frame
Up to the data cutoff date 15 January 2021 (up to approximately 39 months)
Title
Change From Baseline on the C-SSRS
Description
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.
Time Frame
Baseline to data cutoff date 15 January 2021 (up to approximately 39 months)
Title
Other Abnormal MRI Findings
Description
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.
Time Frame
Baseline, Week 9, Week 49, Week 73, Study Treatment Discontinuation, and Week 89
Secondary Outcome Measure Information:
Title
Change From Baseline on the Repeatable Battery for Assessment of Neuropsychological Status (RBANS)
Description
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.
Time Frame
Baseline and 73 weeks
Title
Change From Baseline on the Alzheimer's Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog-13) Subscale Score
Description
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.
Time Frame
Baseline and 73 weeks
Title
Change From Baseline on the Amsterdam Instrumental Activity of Daily Living (iADL) Questionnaire
Description
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.
Time Frame
Baseline and 73 weeks
Title
Change From Baseline on the Alzheimer's Disease Cooperative Study Group-Activities of Daily Living Inventory
Description
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.
Time Frame
Baseline and 73 weeks
Title
Serum Concentrations of Semorinemab at Specified Timepoints
Description
Serum concentrations of Semorinemab at specified timepoints.
Time Frame
Up to 109 weeks
Title
Presence of Anti-drug Antibodies During the Study Relative to Their Presence at Baseline
Description
Presence of anti-drug antibodies during the study relative to their presence at baseline.
Time Frame
Up to 109 weeks

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
35696185
Citation
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.
Results Reference
derived

Learn more about this trial

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

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