NCT07234942Active, not recruitingPhase 1
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 in Participants With Early Symptomatic Alzheimer's Disease (eAD)
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 Following Intrathecal Administration in Participants With Early Symptomatic Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
This study aims to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics following administration of RO7812653 in participants with eAD.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- First submitted
- 14 Nov 2025
- Start date
- 27 Jan 2026
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Alzheimer disease
- NCT number
- NCT07234942
- EU CT number
- 2025-522101-37-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 6
- From 27 Jan 2026 to the primary completion date, 31 Mar 2027
- 16 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any medical history or evidence of a condition other than AD that may affect cognition.
- History of schizophrenia, schizoaffective disorder, major depression or bipolar disorder.'
- Presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological medical conditions which are not stable and adequately controlled or which in the opinion of the investigator could affect the subject's safety in the study or interfere with the study assessments
Other
- Presence of any significant cerebral abnormalities that would contraindicate lumbar puncture, as assessed on MRI
- Any other significant cerebral abnormalities that the Investigator considers clinically significant
Who the study is looking for
- Probable AD dementia (consistent with National Institute on Aging and Alzheimer's Association (NIA-AA) core clinical criteria for probable AD dementia) \[McKhann et al 2011\] or Mild Cognitive Impairment (MCI) due to AD (consistent with the NIA-AA core clinical criteria for mild cognitive impairment due to AD) \[Albert et al 2011\]).
- Willingness and ability to complete all aspects of the study. The participant should be capable of completing assessments either alone or with the help of the study partner.
- Fluency in the language of the tests used at the study site.
- Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted).
- If the participant is receiving symptomatic AD medications, a stable dosing regimen for at least 8 weeks prior to screening and until randomization is required.
- Agreement not to participate in other research studies for the duration of this study.
Age in the registry: 50 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Montreal Neurological Institute Clinical Research Unit Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Toronto Western Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Fundació ACE, Institut Català de Neurociències Aplicades Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Completed |
| Hospital Universitari General de Catalunya Coordinator of this site? Confirm its status | Sant Cugat del Vallès | Spain | Completed |
| Queen Elizabeth Hospital Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| National Hospital For Neurology and Neurosurgery Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Institute of Psychiatry, Psychology and Neuroscience;Department of Old Age Psychiatry Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Southampton General Hospital Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
| Brain Research Center Amsterdam B.V. Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Completed |
| Revit Sp. z o.o. Coordinator of this site? Confirm its status | Bialystok | Poland | Completed |
| Krakowska Akademia Neurologii Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Centrum Medyczne NeuroProtect Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Sahlgrenska University Hospital-Vaestra Goetalandsregionen Coordinator of this site? Confirm its status | Goteborg | Sweden | Recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Huddinge | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.