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