Early symptomatic Alzheimer’s disease (eAD) Nervous System Diseases
Conditions
Interventions
1. RO7812653: Participants will receive a dose of RO7812653 as per the schedule in the protocol.
2. Placebo: Participants will receive a dose of placebo as per the schedule in the protocol.
Sponsors
F. Hoffmann-La Roche AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Screening Clinical Dementia Rating Global Score (CDR-GS) of 0.5 or 1.0 2. Evidence of AD pathological process, as confirmed by the p-tau 181/Aß1-42 ratio CSF test or amyloid beta positron emission tomography (Aß PET) 3. Fluency in the language of the tests used at the study site 4. Adequate visual and auditory acuity, in the investigator’s judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted) 5. If the participant is receiving symptomatic AD medications, a stable dosing regimen for at least 8 weeks prior to screening and until randomisation is required 6. Agreement not to participate in other research studies for the duration of this study
Exclusion criteria
Exclusion criteria: 1. Any evidence of a condition other than AD that may affect cognition (at the time of screening) 2. Presence of any significant cerebral abnormalities that would contraindicate lumbar puncture, as assessed on MRI 3. Any other significant cerebral abnormalities that the Investigator considers clinically significant 4. History of schizophrenia, schizoaffective disorder, major depression or bipolar disorder 5. Impaired coagulation (international normalized ratio [INR] > 1.3 that remains abnormal on retest) 6. Uncontrolled hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percentage of participants with adverse events assessed using NCI CTCAE v5.0 up to approximately 40 weeks 2. Suicidal ideation and behaviours measured using the Columbia-Suicide Severity Rating Scale (C-SSRS) from baseline up to approximately 40 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Plasma concentration of RO7812653 measured using validated assays at multiple timepoints up to approximately 40 weeks 2. Cerebral spinal fluid (CSF) concentration of RO7812653 measured using validated assays at multiple timepoints up to approximately 40 weeks 3. Percentage of participants with anti-drug antibodies (ADAs) to RO7812653 measured using validated assays at multiple timepoints up to approximately 40 weeks | — |
Countries
Canada, England, Netherlands, Poland, Scotland, Spain, Sweden, United Kingdom
Contacts
Public ContactClinical Trials
Outcome results
None listed