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

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ClinicalTrials.gov Identifier: NCT03289143
Recruitment Status : Recruiting
First Posted : September 20, 2017
Last Update Posted : November 27, 2018
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 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 RO7105705 in Patients With Prodromal to Mild Alzheimer's Disease
Actual Study Start Date : October 4, 2017
Estimated Primary Completion Date : September 30, 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 Name: RG6100

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 Name: RG6100

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 Name: RG6100

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.



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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


Contacts
Contact: Reference Study ID: GN39763 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. only) global-roche-genentech-trials@gene.com

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Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.

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: November 27, 2018
Last Verified: November 2018

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:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders