Actively Recruiting

Phase 1
Age: 50Years - 75Years
All Genders
NCT07234942

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

Led by Hoffmann-La Roche · Updated on 2026-05-04

50

Participants Needed

6

Research Sites

214 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 50Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of probable Alzheimer's Disease dementia or mild cognitive impairment due to Alzheimer's Disease according to established criteria
  • Willingness and ability to complete all study assessments, alone or with a study partner
  • Fluency in the language used for study tests
  • Adequate vision and hearing to perform neuropsychological testing (with aids if needed)
  • Stable dosing of symptomatic Alzheimer's medications for at least 8 weeks before screening and until randomization
  • Agreement not to participate in other research studies during this study
Not Eligible

You will not qualify if you...

  • Any medical history or condition other than Alzheimer's Disease that may affect cognition
  • Significant brain abnormalities contraindicating lumbar puncture, as seen on MRI
  • Any other significant brain abnormalities considered clinically important by the investigator
  • History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder
  • Unstable or uncontrolled cardiovascular, respiratory, liver, kidney, digestive, endocrine, or blood conditions that could affect safety or study assessments

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Brain Research Center Amsterdam

Amsterdam, North Holland, Netherlands, 1081 HV

Actively Recruiting

2

Sahlgrenska Universitetssjukhuset

Mlndal, Sweden, 43180

Actively Recruiting

3

Karolinska Universitetssjukhuset

Solna, Sweden, 171 76

Actively Recruiting

4

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

London, Greater London, United Kingdom, SE5 8AF

Actively Recruiting

5

Southampton General Hospital

Southampton, Hampshire, United Kingdom, SO16 6YD

Actively Recruiting

6

National Hospital For Neurology and Neurosurgery

London, United Kingdom, WC1N 3BG

Actively Recruiting

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Research Team

R

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

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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