Alzheimer's DiseasePhase 1NCT02820896
A Study of RO7105705 in Healthy Participants and Participants With Mild-to-Moderate Alzheimer's Disease
A Phase 1 study testing RO7105705 in people with Alzheimer's Disease, run by Genentech, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- RO7105705
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2016to 26 Jun 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New Orleans Center for Clinical Research
Knoxville, Tennessee, 37920
About this study
Official title: 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.
- Conditions
- Alzheimer's Disease
- Being tested
- Placebo, RO7105705
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Participants will receive single or multiple doses of RO7105705 matching placebo IV.
RO7105705Drug
Participants will receive single or multiple doses of RO7105705 IV or SC.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Dose Placebo IV | Placebo comparator | Healthy participants or participants with Alzheimer's disease will receive multiple doses of matching placebo IV QW, a total of 4 doses. Receives: Drug: Placebo |
| Multiple Dose RO7105705 IV | Experimental | Healthy participants or participants with Alzheimer's disease will receive multiple doses of RO7105705 IV QW, a total of 4 doses. Receives: Drug: RO7105705 |
| Single Dose RO7105705 SC | Experimental | Healthy participants will receive a single dose of RO7105705 SC on Day 1. Receives: Drug: RO7105705 |
| Single dose Placebo IV | Placebo comparator | Healthy participants will receive a single dose of placebo IV on Day 1. Receives: Drug: Placebo |
| Single dose RO7105705 IV | Experimental | Healthy participants will receive a single dose of RO7105705 IV on Day 1. Receives: Drug: RO7105705 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events
Measured: Screening up to Day 134
Number of Participants with Dose Limiting Adverse Events (DLAEs)
Measured: Day 1 up to Day 36
Change from Baseline in Suicidal Ideation and Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS) Score
Measured: Baseline, up to approximately 134 days
Secondary outcomes (6)
Change From Baseline to Week 19 in Global Function as Assessed Using the Clinical Dementia Rating (CDR) Global Score in Alzheimer's Disease Participants
Measured: Baseline, Week 19
Percentage of Participants with Anti-Therapeutic Antibodies (ATAs)
Measured: Baseline, Days 29, 57, 113
Serum Concentration of RO7105705 - Single Dose Cohorts: IV Administration
Measured: 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
Serum Concentration of RO7105705 - Single Dose Cohorts: SC Administration
Measured: Pre-dose, Hour 4, 8, 12 on Day 1, Days 2, 3, 4, 6, 8, 15, 29, 43, 57, 85, 113
Serum Concentration of RO7105705 - Multiple Dose Cohorts: IV Administration
Measured: 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
Change From Baseline to Week 19 in Cognitive Function as Assessed Using the Mini-Mental State Examination (MMSE) in Alzheimer's Disease Participants
Measured: Baseline, Week 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study start29 Jun 2016
- Primary completion26 Jun 2017
- Study completion26 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820896
- Sponsor's protocol ID
- GN39058
- Status last verified
- Jul 2017
- First submitted
- 29 Jun 2016
- Last updated
- 21 Jul 2017
- Results posted
- No
Publications
Schauer SP, Toth B, Lee J, Honigberg LA, Ramakrishnan V, Jiang J, Kollmorgen G, Bayfield A, Wild N, Hoffman J, Ceniceros R, Dolton M, Bohorquez SMS, Hoogenraad CC, Wildsmith KR, Teng E, Monteiro C, Anania V, Yeh FL. Pharmacodynamic effects of semorinemab on plasma and CSF biomarkers of Alzheimer's disease pathophysiology. Alzheimers Dement. 2024 Dec;20(12):8855-8866. doi: 10.1002/alz.14346. Epub 2024 Nov 8.
PubMed 39513754Ramakrishnan V, Bender B, Langenhorst J, Magnusson MO, Dolton M, Shim J, Fuji RN, Monteiro C, Teng E, Kassir N, Jin J. Semorinemab Pharmacokinetics and The Effect on Plasma Total Tau Pharmacodynamics in Clinical Studies. J Prev Alzheimers Dis. 2024;11(5):1241-1250. doi: 10.14283/jpad.2024.146.
PubMed 39350369
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02820896
- Acronym / sponsor ID
- GN39058
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jun 2016 (actual)
- Primary completion
- 26 Jun 2017 (actual)
- Study completion
- 26 Jun 2017 (actual)
- First posted
- 1 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Multiple Dose Placebo IV | Placebo comparator | Drug: PlaceboHealthy participants or participants with Alzheimer's disease will receive multiple doses of matching placebo IV QW, a total of 4 doses. |
| Multiple Dose RO7105705 IV | Experimental | Drug: RO7105705Healthy participants or participants with Alzheimer's disease will receive multiple doses of RO7105705 IV QW, a total of 4 doses. |
| Single Dose RO7105705 SC | Experimental | Drug: RO7105705Healthy participants will receive a single dose of RO7105705 SC on Day 1. |
| Single dose Placebo IV | Placebo comparator | Drug: PlaceboHealthy participants will receive a single dose of placebo IV on Day 1. |
| Single dose RO7105705 IV | Experimental | Drug: RO7105705Healthy participants will receive a single dose of RO7105705 IV on Day 1. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboParticipants will receive single or multiple doses of RO7105705 matching placebo IV. | Drug | Multiple Dose Placebo IV, Single dose Placebo IV |
| RO7105705Participants will receive single or multiple doses of RO7105705 IV or SC. | Drug | Multiple Dose RO7105705 IV, Single Dose RO7105705 SC, Single dose RO7105705 IV |
Primary outcome
Number of Participants with Adverse Events
Time frame: Screening up to Day 134
Number of Participants with Dose Limiting Adverse Events (DLAEs)
Time frame: Day 1 up to Day 36
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
6 secondary outcomes
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
Percentage of Participants with Anti-Therapeutic Antibodies (ATAs)
Time frame: Baseline, Days 29, 57, 113
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Derived from this study: PubMed 39513754Schauer SP, Toth B, Lee J, Honigberg LA, Ramakrishnan V, Jiang J, Kollmorgen G, Bayfield A, Wild N, Hoffman J, Ceniceros R, Dolton M, Bohorquez SMS, Hoogenraad CC, Wildsmith KR, Teng E, Monteiro C, Anania V, Yeh FL. Pharmacodynamic effects of semorinemab on plasma and CSF biomarkers of Alzheimer's disease pathophysiology. Alzheimers Dement. 2024 Dec;20(12):8855-8866. doi: 10.1002/alz.14346. Epub 2024 Nov 8.
- Derived from this study: PubMed 39350369Ramakrishnan V, Bender B, Langenhorst J, Magnusson MO, Dolton M, Shim J, Fuji RN, Monteiro C, Teng E, Kassir N, Jin J. Semorinemab Pharmacokinetics and The Effect on Plasma Total Tau Pharmacodynamics in Clinical Studies. J Prev Alzheimers Dis. 2024;11(5):1241-1250. doi: 10.14283/jpad.2024.146.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO7105705 in people with Alzheimer's Disease, run by Genentech, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (time frame: Screening up to Day 134). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02820896, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.