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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522101-37-00 | EU Trial (CTIS) Number |
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This study aims to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics following administration of RO7812653 in participants with eAD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RO7812653 | Experimental | Participants will receive a dose of RO7812653 |
|
| Placebo | Placebo Comparator | Participants will receive a dose of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7812653 | Drug | Participants will receive RO7812653 as per the schedule in the protocol |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events | Up to approximately 40 weeks | |
| Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores | C-SSRS measures 4 constructs as follows: severity of ideation, intensity of ideation, behavior, and lethality of actual suicide attempts. Binary (yes/no) data are collected for 10 categories. Numeric ratings are provided for intensity of ideation (if present), from 1 to 5, with 1 being the least severe and 5 being the most severe. | Up to approximately 40 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of RO7812653 | Up to approximately 40 weeks | |
| Cerebral Spinal Fluid (CSF) Concentration of RO7812653 | Up to approximately 40 weeks | |
| Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7812653 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: BP45770 https://forpatients.roche.com/ | Contact | 888-662-6728 (U.S. and Canada) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal Neurological Institute Clinical Research Unit | Recruiting | Montreal | Quebec | H3A 2B4 | Canada | |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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| Placebo |
| Drug |
Participants will receive placebo as per the schedule in the protocol |
|
| Up to approximately 40 weeks |
| Brain Research Center Amsterdam |
| Recruiting |
| Amsterdam |
| North Holland |
| 1081 HV |
| Netherlands |
| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | 08025 | Spain |
| Hospital Universitario Reina Sofia | Recruiting | Córdoba | 14004 | Spain |
| Sahlgrenska Universitetssjukhuset | Recruiting | Mlndal | 43180 | Sweden |
| Karolinska Universitetssjukhuset | Recruiting | Solna | 171 76 | Sweden |
| Institute of Psychiatry, Psychology and Neuroscience;Department of Old Age Psychiatry | Recruiting | London | Greater London | SE5 8AF | United Kingdom |
| Southampton General Hospital | Recruiting | Southampton | Hampshire | SO16 6YD | United Kingdom |
| Queen Elizabeth Hospital | Recruiting | Glasgow | Strathclyde | G21 3UW | United Kingdom |
| National Hospital For Neurology and Neurosurgery | Recruiting | London | WC1N 3BG | United Kingdom |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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