A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812… (NCT07234942) | Clinical Trial Compass
RecruitingPhase 1
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 in Participants With Early Symptomatic Alzheimer's Disease (eAD)
Netherlands, Sweden, United Kingdom50 participantsStarted 2026-01-27
Plain-language summary
This study aims to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics following administration of RO7812653 in participants with eAD.
Who can participate
Age range50 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Any medical history or evidence of a condition other than AD that may affect cognition.
* 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
* History of schizophrenia, schizoaffective disorder, major depression or bipolar disorder.'
* Presence of cardiovascular, respiratory, hepatic, renal, gas…
What they're measuring
1
Percentage of Participants with Adverse Events
Timeframe: Up to approximately 40 weeks
2
Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores
Timeframe: Up to approximately 40 weeks
Trial details
NCT IDNCT07234942
SponsorHoffmann-La Roche
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2028-04-19
Contact for this trial
Reference Study ID Number: BP45770 https://forpatients.roche.com/