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NCT Number: NCT07234942

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

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

Recruiting

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Montreal Neurological Institute Clinical Research Unit, Montreal, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO7812653

Drug

Participants will receive RO7812653 as per the schedule in the protocol

Placebo

Drug

Participants will receive placebo as per the schedule in the protocol

Primary outcomes

  1. Percentage of Participants with Adverse Events

    Time frame: Up to approximately 40 weeks

  2. Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores

    Time frame: 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.

Secondary outcomes

  1. Plasma Concentration of RO7812653

    Time frame: Up to approximately 40 weeks

  2. Cerebral Spinal Fluid (CSF) Concentration of RO7812653

    Time frame: Up to approximately 40 weeks

  3. Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7812653

    Time frame: Up to approximately 40 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Reference Study ID Number: BP45770 https://forpatients.roche.com/

CONTACT

[email protected]

888-662-6728 (U.S. and Canada)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Nov 19, 2025
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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