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

NCT07234942 | Recruiting Phase 1

• 2 other identifiers: BP457702025-522101-37-00
• Study Type: interventional
• Target: 50
• Locations: 3 countries
• Sites: 6

Brief Summary

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

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants with Adverse Events

  Up to approximately 40 weeks

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

  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.

  Up to approximately 40 weeks

Secondary Outcomes (3)

• Plasma Concentration of RO7812653

  Up to approximately 40 weeks

• Cerebral Spinal Fluid (CSF) Concentration of RO7812653

  Up to approximately 40 weeks

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

  Up to approximately 40 weeks

Study Arms (2)

RO7812653

EXPERIMENTAL

Participants will receive a dose of RO7812653

Drug: RO7812653

Placebo

PLACEBO COMPARATOR

Participants will receive a dose of placebo

Drug: Placebo

Interventions

RO7812653 DRUG

Participants will receive RO7812653 as per the schedule in the protocol

RO7812653

Placebo DRUG

Participants will receive placebo as per the schedule in the protocol

Placebo

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (6)

Brain Research Center Amsterdam

Amsterdam, North Holland, 1081 HV, Netherlands

RECRUITING

Sahlgrenska Universitetssjukhuset

Mlndal, 43180, Sweden

RECRUITING

Karolinska Universitetssjukhuset

Solna, 171 76, Sweden

RECRUITING

Institute of Psychiatry, Psychology and Neuroscience;Department of Old Age Psychiatry

London, Greater London, SE5 8AF, United Kingdom

RECRUITING

Southampton General Hospital

Southampton, Hampshire, SO16 6YD, United Kingdom

RECRUITING

National Hospital For Neurology and Neurosurgery

London, WC1N 3BG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

888-662-6728 (U.S. and Canada); global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: January 27, 2026
• Primary Completion (Estimated): April 19, 2028
• Study Completion (Estimated): March 5, 2030
• Last Updated: May 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); GB (3); SE (2)