NCT07234942 · Phase 1 · RECRUITING
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 in Participants With Early Symptomatic Alzheimer's Disease (eAD)
This Phase 1 trial is testing a new drug called RO7812653 in people with early Alzheimer's disease, including those with mild cognitive impairment or early dementia. Phase 1 means the primary goal is safety — researchers want to know if the drug is tolerable and how the body processes it, not yet whether it slows the disease. Details on how the drug works are limited so far.
You may qualify if
- 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.
You're excluded if
- 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, 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
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 2026-06-02