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A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 in Participants With Early Symptomatic Alzheimer's Disease (eAD)
Led by Hoffmann-La Roche · Updated on 2026-05-04
50
Participants Needed
6
Research Sites
214 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics following administration of RO7812653 in participants with eAD.
CONDITIONS
Official Title
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 in Participants With Early Symptomatic Alzheimer's Disease (eAD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of probable Alzheimer's Disease dementia or mild cognitive impairment due to Alzheimer's Disease according to established criteria
- Willingness and ability to complete all study assessments, alone or with a study partner
- Fluency in the language used for study tests
- Adequate vision and hearing to perform neuropsychological testing (with aids if needed)
- Stable dosing of symptomatic Alzheimer's medications for at least 8 weeks before screening and until randomization
- Agreement not to participate in other research studies during this study
You will not qualify if you...
- Any medical history or condition other than Alzheimer's Disease that may affect cognition
- Significant brain abnormalities contraindicating lumbar puncture, as seen on MRI
- Any other significant brain abnormalities considered clinically important by the investigator
- History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder
- Unstable or uncontrolled cardiovascular, respiratory, liver, kidney, digestive, endocrine, or blood conditions that could affect safety or study assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Brain Research Center Amsterdam
Amsterdam, North Holland, Netherlands, 1081 HV
Actively Recruiting
2
Sahlgrenska Universitetssjukhuset
Mlndal, Sweden, 43180
Actively Recruiting
3
Karolinska Universitetssjukhuset
Solna, Sweden, 171 76
Actively Recruiting
4
Institute of Psychiatry, Psychology and Neuroscience;Department of Old Age Psychiatry
London, Greater London, United Kingdom, SE5 8AF
Actively Recruiting
5
Southampton General Hospital
Southampton, Hampshire, United Kingdom, SO16 6YD
Actively Recruiting
6
National Hospital For Neurology and Neurosurgery
London, United Kingdom, WC1N 3BG
Actively Recruiting
Research Team
R
Reference Study ID Number: BP45770 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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