A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 in Participants With Early Symptomatic Alzheimer's Disease (eAD)

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age50-75
SponsorHoffmann-La Roche

About this trial

This study aims to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics following administration of RO7812653 in participants with eAD.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.'

Trial design

Treatments tested in this trial

  • RO7812653
  • Placebo

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators