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A Study to Evaluate the Efficacy and Safety of Semorinemab 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 : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE September 18, 2017
First Posted Date  ICMJE September 20, 2017
Last Update Posted Date June 24, 2020
Actual Study Start Date  ICMJE October 4, 2017
Estimated Primary Completion Date June 24, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2018)
  • 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.
  • Percentage of Participants with Adverse Events [ Time Frame: Up to 181 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 18, 2017)
  • Change from baseline on the CDR-Sum of Boxes [ Time Frame: 72 Weeks ]
    A scale used to quantify the severity of symptoms of dementia.
  • Nature, frequency, severity, and timing of adverse events and serious adverse events [ Time Frame: Up to 180 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • Serum concentrations of RO7105705 at specified timepoints [ Time Frame: Up to 181 weeks ]
  • Presence of anti-drug antibodies during the study relative to their presence at baseline [ Time Frame: Up to 181 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2017)
  • Change From Baseline on the Repeatable Battery for Assessment of Neuropsychological Status (RBANS) [ Time Frame: 72 weeks ]
    A scale used to quantify cognitive function across multiple domains.
  • Change from baseline on the Alzheimer's Disease Assessment Scale−Cognitive Subscale 13 [ Time Frame: 72 weeks ]
    A scale used to quantify the areas of cognitive function most often affected in Alzheimer's disease.
  • Change from baseline on the Amsterdam Instrumental Activity of Daily Living questionnaire [ Time Frame: 72 weeks ]
    A scale used to quantify performance of activities of daily living.
  • Change from baseline on the Alzheimer's Disease Cooperative Study Group−Activities of Daily Living Inventory [ Time Frame: 72 weeks ]
    A scale used to quantify performance of activities of daily living.
  • Serum concentrations of RO7105705 at specified timepoints [ Time Frame: Up to 180 weeks ]
  • Presence of anti-drug antibodies during the study relative to their presence at baseline [ Time Frame: Up to 180 weeks ]
Current Other Pre-specified Outcome Measures
 (submitted: October 15, 2018)
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.
Original Other Pre-specified Outcome Measures
 (submitted: September 18, 2017)
Change from baseline in brain tau burden as measured by [18F]GTP1-PET [ Time Frame: 72 weeks ]
[18F]GTP1-PET is a brain imaging technology that allows visualization of the location and extent of tau pathology in the brain.
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy and Safety of Semorinemab in Patients With Prodromal to Mild Alzheimer's Disease
Official Title  ICMJE 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
Brief Summary This is 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 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 Semorinemab treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: Semorinemab
    Participants will receive Semorinemab intravenously (IV).
    Other Names:
    • RG6100
    • MTAU9937A
    • RO7105705
  • Drug: Placebo
    Matching placebo doses of Semorinemab 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
Study Arms  ICMJE
  • Experimental: Dose 1 Semorinemab
    Interventions:
    • Drug: Semorinemab
    • Drug: [18F]GTP1
  • Experimental: Dose 2 Semorinemab
    Interventions:
    • Drug: Semorinemab
    • Drug: [18F]GTP1
  • Experimental: Dose 3 Semorinemab
    Interventions:
    • Drug: Semorinemab
    • Drug: [18F]GTP1
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: Placebo
    • Drug: [18F]GTP1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 16, 2019)
457
Original Estimated Enrollment  ICMJE
 (submitted: September 18, 2017)
360
Estimated Study Completion Date  ICMJE June 21, 2022
Estimated Primary Completion Date June 24, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Denmark,   France,   Germany,   Italy,   Netherlands,   Poland,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries Finland
 
Administrative Information
NCT Number  ICMJE NCT03289143
Other Study ID Numbers  ICMJE GN39763
2017-001800-31 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Genentech, Inc.
PRS Account Genentech, Inc.
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP