ISRCTN10651912 · Phase 1 · RECRUITING

First-in-human study of RO7812653

This trial tests an experimental drug called RO7812653, given by injection into the lower back, in people with early symptomatic Alzheimer's. It mainly measures safety at different doses and how the body processes the drug. It is a Phase 1 trial, the first time it is being tried in humans, so it is not yet shown to work.

You may qualify if

  • Screening Clinical Dementia Rating Global Score (CDR-GS) of 0.5 or 1.0
  • Evidence of AD pathological process, as confirmed by the p-tau 181/Aβ1-42 ratio CSF test or amyloid beta positron emission tomography (Aβ PET)
  • 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 randomisation is required
  • Agreement not to participate in other research studies for the duration of this study

You're excluded if

  • Any evidence of a condition other than AD that may affect cognition (at the time of screening)
  • 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
  • Impaired coagulation (international normalized ratio [INR] > 1.3 that remains abnormal on retest)
  • Uncontrolled hypertension

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2026-01-21

View full record on ISRCTN

Source: ISRCTN registry, record ISRCTN10651912, retrieved 2026-10-27. Registry text licensed CC BY 4.0.

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