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

Last updated: May 1, 2026
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

1

Condition

Dementia

Memory Loss

Alzheimer's Disease

Treatment

Placebo

RO7812653

Clinical Study ID

NCT07234942
BP45770
2025-522101-37-00
  • Ages 50-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Probable AD dementia (consistent with National Institute on Aging and Alzheimer'sAssociation (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 coreclinical criteria for mild cognitive impairment due to AD) [Albert et al 2011]).

  • Willingness and ability to complete all aspects of the study. The participant shouldbe capable of completing assessments either alone or with the help of the studypartner.

  • Fluency in the language of the tests used at the study site.

  • Adequate visual and auditory acuity, in the investigator's judgment, sufficient toperform the neuropsychological testing (eyewear and hearing aids are permitted).

  • If the participant is receiving symptomatic AD medications, a stable dosing regimenfor at least 8 weeks prior to screening and until randomization is required.

  • Agreement not to participate in other research studies for the duration of thisstudy.

Exclusion

Exclusion Criteria:

  • Any medical history or evidence of a condition other than AD that may affectcognition.

  • Presence of any significant cerebral abnormalities that would contraindicate lumbarpuncture, as assessed on MRI

  • Any other significant cerebral abnormalities that the Investigator considersclinically significant

  • History of schizophrenia, schizoaffective disorder, major depression or bipolardisorder.'

  • Presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal,endocrine, hematological medical conditions which are not stable and adequatelycontrolled or which in the opinion of the investigator could affect the subject'ssafety in the study or interfere with the study assessments

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
January 27, 2026
Estimated Completion Date:
March 05, 2030

Connect with a study center

  • Brain Research Center Amsterdam

    Amsterdam, North Holland 1081 HV
    Netherlands

    Active - Recruiting

  • Sahlgrenska Universitetssjukhuset

    Mlndal, 43180
    Sweden

    Active - Recruiting

  • Karolinska Universitetssjukhuset

    Solna, 171 76
    Sweden

    Active - Recruiting

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

    London, Greater London SE5 8AF
    United Kingdom

    Active - Recruiting

  • Southampton General Hospital

    Southampton, Hampshire SO16 6YD
    United Kingdom

    Active - Recruiting

  • National Hospital For Neurology and Neurosurgery

    London, WC1N 3BG
    United Kingdom

    Active - Recruiting

  • National Hospital For Neurology and Neurosurgery

    London 2643743, WC1N 3BG
    United Kingdom

    Site Not Available

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