Alzheimer's Disease / RO7812653 · Phase 1 Trial

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

ClinicalTrials.gov · September 9, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 1 trial registry record describing a planned safety and tolerability study of RO7812653 in early symptomatic Alzheimer's disease. No results are reported in this registry record; the study is active but not currently recruiting. The small planned sample reflects the early-phase nature of the investigation.

What was studied

Phase 1, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Alzheimer's Disease; age from 50 Years; to 75 Years. Intervention: RO7812653. Compared with: Placebo — Placebo Comparator. n = 6. 12 sites across 5 countries.

Key findings

Safety

No efficacy outcomes are planned; only safety, tolerability, and pharmacodynamic measures are specified.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a Phase 1 clinical trial registry record with no results posted; it describes planned safety and tolerability assessment in a small early-stage cohort.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Percentage of Participants with Adverse Events (assessed at Up to approximately 40 weeks); Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores (assessed at Up to approximately 40 weeks)

DesignPhase 1, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose

PopulationAlzheimer's Disease; age from 50 Years; to 75 Years

Sample size6

InterventionRO7812653

ComparatorPlacebo — Placebo Comparator

Setting12 sites across 5 countries

Reported figures

Quoted from the source exactly as published.

Planned enrollment6

Study phasePhase 1

Primary outcome measure 1Percentage of Participants with Adverse Events, up to approximately 40 weeks

Primary outcome measure 2Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores, up to approximately 40 weeks

Follow-up durationapproximately 40 weeks

Caveats

This is a registry record only; no trial results are posted or reported here.
Sample size of 6 participants is very small and reflects early Phase 1 scope.
No efficacy outcomes are planned; only safety, tolerability, and pharmacodynamic measures are specified.
Detailed inclusion/exclusion criteria, randomization method, and blinding procedures are not provided in this registry text.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 1, interventional, placebo-controlled design appropriate for safety assessment.

Directness

strong

Primary outcomes are safety, tolerability, and pharmacodynamics in target population.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

Study methods and blinding details not specified in registry record.

Sample adequacy

limited

Enrollment of 6 participants is typical for Phase 1 but insufficient for efficacy claims.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07234942). This is a study registration, not published results. Lead sponsor: Hoffmann-La Roche. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 6 participants (ACTUAL). Conditions: Alzheimer's Disease. Interventions: DRUG: RO7812653; DRUG: Placebo. Primary outcome measures: 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. Brief summary: This study aims to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics following administration of RO7812653 in participants with eAD.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT07234942Alzheimer's DiseaseRO7812653Hoffmann-La Roche