Ireland
--:--IST
Active, not recruiting Phase 1

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

NCT07234942 · tracked via the Priya Life Science Netherlands tracker
Phase
Phase 1
Started
2026-01-27
Last updated
2026-09-09

Condition(s) studied

Alzheimer's Disease

Investigational drug(s) / intervention(s)

RO7812653Placebo

RO7812653: Participants will receive RO7812653 as per the schedule in the protocol

Placebo: Participants will receive placebo as per the schedule in the protocol

Study summary

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

Eligibility

Sex
ALL
Min age
50 Years
Max age
75 Years
Healthy volunteers
No
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, 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

Primary outcome measure(s)

  • Percentage of Participants with Adverse Events — Up to approximately 40 weeks
  • Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores — Up to approximately 40 weeks
    C-SSRS measures 4 constructs as follows: severity of ideation, intensity of ideation, behavior, and lethality of actual suicide attempts. Binary (yes/no) data are collected for 10 categories. Numeric ratings are provided for intensity of ideation (if present), from 1 to 5, with 1 being the least severe and 5 being the most severe.

Trial sites (12)

FacilityCityRegionStatus
Toronto Western Hospital Toronto Ontario
Montreal Neurological Institute Clinical Research Unit Montreal Quebec
Brain Research Center Amsterdam Amsterdam North Holland
Hospital General de Catalunya Sant Cugat del Vallès Barcelona
Hospital de la Santa Creu i Sant Pau Barcelona Spain
Hospital Universitario Reina Sofia Córdoba Spain
Sahlgrenska Universitetssjukhuset, Mlndal Sjukhus Mlndal Sweden
Karolinska Universitetssjukhuset Solna Sweden
Institute of Psychiatry, Psychology and Neuroscience;Department of Old Age Psychiatry London Greater London
Southampton General Hospital Southampton Hampshire
Queen Elizabeth Hospital Glasgow Strathclyde
National Hospital For Neurology and Neurosurgery London United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07234942 on ClinicalTrials.gov ↗ ← All trials in the Netherlands