- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02820896
A Study of RO7105705 in Healthy Participants and Participants With Mild-to-Moderate Alzheimer's Disease
July 19, 2017 updated by: Genentech, Inc.
A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenous and Subcutaneous RO7105705 Administered in Healthy Volunteers and Patients With Mild-to-Moderate Alzheimer's Disease
This is a Phase I, randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics, and preliminary activity of RO7105705 in two participant populations: healthy participants and participants with mild-to-moderate Alzheimer's disease.
This study is a single dose, dose-escalation, and multiple dose study comprising approximately six single dose cohorts in healthy participants administered RO7105705, either intravenously (IV) or subcutaneously (SC), and comprising one or more multiple dose cohorts in healthy participants administered RO7105705 IV every week (QW), a total of 4 doses, and one or more multiple dose cohorts in participants with Alzheimer's disease administered RO7105705 IV QW, a total of 4 doses.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
74
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Tennessee
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Knoxville, Tennessee, United States, 37920
- New Orleans Center for Clinical Research
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
All participants
- Total body weight between 45 and 120 kilogram (kg), inclusive
- Agreement not to donate blood or blood products for transfusion for the duration of the study and for 1 year after final dose of study drug
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), laboratory tests, and vital signs
- Clinical laboratory evaluations (including chemistry panel fasted [fasted at least 8 hours], complete blood count (CBC), and urine analysis) within the reference range for the test laboratory, unless deemed not clinically significant by the investigator
- Negative test for selected drugs of abuse at screening and at check-in
- Agreement to use highly effective contraception measures
Healthy Participants
- Ages 18-80 years inclusive
- No history of symptomatic cognitive decline and no concern about clinically significant cognitive impairment by the participant or by the investigator
Participants who enroll into a cohort that requires lumbar puncture
- No contraindication to lumbar dural puncture, including coagulopathy, concomitant anticoagulation, thrombocytopenia, prior lumbar spinal surgery, or other factor that precludes safe lumbar puncture in the opinion of the investigator
Participants with Alzheimer's disease
- Ages 50-80 years, inclusive
- The participant should be capable of completing assessments either alone or with the help of the caregiver
- Availability of a person (caregiver) who, in the investigator's judgment, has frequent and sufficient contact with the participant and is able to provide accurate information regarding the participant's cognitive and functional abilities, agrees to provide information at clinic visits, which require partner input for scale completion, and signs the necessary consent form
- Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing
- Clinical diagnosis of probable Alzheimer's disease dementia based on National Institute on Aging-Alzheimer's Association criteria
- Screening mini-mental state examination (MMSE) score of 16-28 points, inclusive
- Screening Clinical Dementia Rating-Global Score (CDR-GS) of 0.5, 1.0, or 2.0
- Positive florbetapir amyloid positron emission tomography (PET) scan by qualitative read
- If already taking cholinesterase inhibitor and/or memantine therapy for Alzheimer's disease, on a stable dose for at least 4 weeks prior to screening. There should be no intent to, discontinue, or alter the dose of any Alzheimer's disease therapy for the duration of the study
Exclusion Criteria:
Any participants
- Pregnant or lactating, or intending to become pregnant within 16 weeks after last dose of study drug
- Participation in a clinical trial within 30 days before randomization; use of any experimental oral therapy within 30 days or 5 half-lives prior to Day 1, whichever is greater; or use of any biologic therapy within 12 weeks or 5 half-lives prior to Day 1, whichever is greater
- Any non-experimental vaccine within 2 weeks of randomization, until 2 weeks after the last dose
- Surgery or hospitalization during the 4 weeks prior to screening
- Planned procedure or surgery during the study
- Blood transfusion within 8 weeks prior to screening
- Donation or loss of blood (excluding the volume of blood that will be drawn during screening procedures) as follows: 50-499 milliliters (mL) of blood within 30 days or greater than (>) 499 mL of blood within 56 days prior to study drug administration
- Poor peripheral venous access
- Positive for hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody
- Illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment
- Administration of any herbal or nutritional supplements (with the exception of standard vitamins and calcium supplements) within 7 days prior to study dose
- Past history of seizures, prior traumatic brain injury, schizophrenia, schizoaffective disorder, or bipolar disorder
- At risk of suicide in the opinion of the investigator
- Serious infection requiring oral and IV antibiotics within 30 days prior to screening
- Any serious medical condition or abnormality in clinical laboratory tests; systemically, clinically immunocompromised because of continuing effects of immune-suppressing medication
Participants with Alzheimer's disease
- History or presence of clinically evident vascular disease potentially affecting the brain
- History or presence of stroke within the previous 2 years or documented history of transient ischemic attack within the previous 12 months
- History or presence of intracranial tumor that is clinically relevant in the opinion of the investigator
- Presence of infections that affect brain function or history of infections that resulted in neurologic sequelae
- History or presence of central nervous system (CNS) or systemic autoimmune disorders potentially causing progressive neurologic disease with associated cognitive deficits
- History or presence of a neurologic disease other than Alzheimer's disease that may affect cognition
- Magnetic resonance imaging (MRI) evidence of 1) more than two lacunar infarcts, 2) any territorial infarct less than (>) 1 centimeters (cm), or 3) significant fluid attenuated inversion recovery (FLAIR) hyperintense lesions in the cerebral white matter that may, in the investigator's opinion, contribute to cognitive dysfunction
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Multiple Dose Placebo IV
Healthy participants or participants with Alzheimer's disease will receive multiple doses of matching placebo IV QW, a total of 4 doses.
|
Participants will receive single or multiple doses of RO7105705 matching placebo IV.
|
Experimental: Multiple Dose RO7105705 IV
Healthy participants or participants with Alzheimer's disease will receive multiple doses of RO7105705 IV QW, a total of 4 doses.
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Participants will receive single or multiple doses of RO7105705 IV or SC.
|
Experimental: Single Dose RO7105705 SC
Healthy participants will receive a single dose of RO7105705 SC on Day 1.
|
Participants will receive single or multiple doses of RO7105705 IV or SC.
|
Placebo Comparator: Single dose Placebo IV
Healthy participants will receive a single dose of placebo IV on Day 1.
|
Participants will receive single or multiple doses of RO7105705 matching placebo IV.
|
Experimental: Single dose RO7105705 IV
Healthy participants will receive a single dose of RO7105705 IV on Day 1.
|
Participants will receive single or multiple doses of RO7105705 IV or SC.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants with Adverse Events
Time Frame: Screening up to Day 134
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Screening up to Day 134
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Number of Participants with Dose Limiting Adverse Events (DLAEs)
Time Frame: Day 1 up to Day 36
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Day 1 up to Day 36
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Change from Baseline in Suicidal Ideation and Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS) Score
Time Frame: Baseline, up to approximately 134 days
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Baseline, up to approximately 134 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change From Baseline to Week 19 in Global Function as Assessed Using the Clinical Dementia Rating (CDR) Global Score in Alzheimer's Disease Participants
Time Frame: Baseline, Week 19
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Baseline, Week 19
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Percentage of Participants with Anti-Therapeutic Antibodies (ATAs)
Time Frame: Baseline, Days 29, 57, 113
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Baseline, Days 29, 57, 113
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Serum Concentration of RO7105705 - Single Dose Cohorts: IV Administration
Time Frame: Pre-dose, end of infusion (60-90 minutes), Hour 4, 8, 12 on Day 1, Days 2, 3, 8, 15, 29, 43, 57, 85, 113
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Pre-dose, end of infusion (60-90 minutes), Hour 4, 8, 12 on Day 1, Days 2, 3, 8, 15, 29, 43, 57, 85, 113
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Serum Concentration of RO7105705 - Single Dose Cohorts: SC Administration
Time Frame: Pre-dose, Hour 4, 8, 12 on Day 1, Days 2, 3, 4, 6, 8, 15, 29, 43, 57, 85, 113
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Pre-dose, Hour 4, 8, 12 on Day 1, Days 2, 3, 4, 6, 8, 15, 29, 43, 57, 85, 113
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Serum Concentration of RO7105705 - Multiple Dose Cohorts: IV Administration
Time Frame: Pre-dose, end of infusion (60-90 minutes), Hour 4, 8, 12 on Days 1, 8 15, 22, Days 2, 3, 23, 29, 36, 50, 64, 78, 106, 134
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Pre-dose, end of infusion (60-90 minutes), Hour 4, 8, 12 on Days 1, 8 15, 22, Days 2, 3, 23, 29, 36, 50, 64, 78, 106, 134
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Change From Baseline to Week 19 in Cognitive Function as Assessed Using the Mini-Mental State Examination (MMSE) in Alzheimer's Disease Participants
Time Frame: Baseline, Week 19
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Baseline, Week 19
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 29, 2016
Primary Completion (Actual)
June 26, 2017
Study Completion (Actual)
June 26, 2017
Study Registration Dates
First Submitted
June 29, 2016
First Submitted That Met QC Criteria
June 29, 2016
First Posted (Estimate)
July 1, 2016
Study Record Updates
Last Update Posted (Actual)
July 21, 2017
Last Update Submitted That Met QC Criteria
July 19, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GN39058
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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