Recruiting NCT07234942
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 in Participants With Early Symptomatic Alzheimer's Disease (eAD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RO7812653, Placebo.
- Who it may be relevant to
- Registry conditions: Alzheimer's Disease. Basic parameters: 50 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada, Netherlands, Spain, Sweden, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 Following Intrathecal Administration in Participants With Early Symptomatic Alzheimer's Disease
Overview
This study aims to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics following administration of RO7812653 in participants with eAD.
Interventions
- Drug RO7812653
Participants will receive RO7812653 as per the schedule in the protocol - Drug Placebo
Participants will receive placebo as per the schedule in the protocol
Primary outcome measures
- Percentage of Participants with Adverse Events [Time frame: Up to approximately 40 weeks]
- Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores [Time frame: Up to approximately 40 weeks]
Secondary outcome measures (3)
- Plasma Concentration of RO7812653 [Time frame: Up to approximately 40 weeks]
- Cerebral Spinal Fluid (CSF) Concentration of RO7812653 [Time frame: Up to approximately 40 weeks]
- Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7812653 [Time frame: Up to approximately 40 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United Kingdom · 4 centers
- Institute of Psychiatry, Psychology and Neuroscience;Department of Old Age Psychiatry — London
- Southampton General Hospital — Southampton
- Queen Elizabeth Hospital — Glasgow
- National Hospital For Neurology and Neurosurgery — London
Spain · 3 centers
- Hospital General de Catalunya — Sant Cugat del Vallès
- Hospital de la Santa Creu i Sant Pau — Barcelona
- Hospital Universitario Reina Sofia — Córdoba
Canada · 2 centers
- Toronto Western Hospital — Toronto
- Montreal Neurological Institute Clinical Research Unit — Montreal
Sweden · 2 centers
- Sahlgrenska Universitetssjukhuset — Mlndal
- Karolinska Universitetssjukhuset — Solna
Netherlands · 1 center
- Brain Research Center Amsterdam — Amsterdam
Identifiers
NCT: NCT07234942 · BP45770 · 2025-522101-37-00