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ACTIVE NOT RECRUITINGPhase1

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

Sponsor: Hoffmann-La Roche

NCT ID: NCT07234942

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
RO7812653 (drug), Placebo (drug)
How long the study runs
Study runs about 14 months (dates as stated)
About the drug or intervention
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
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
50 Years to 75 Years
Who
All
Number of participants
6
Started
2026-01-27
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for alzheimer's disease
  • • Phase1 - 6 participants
  • • This study aims to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics following administration of RO7812653 in participants with eAD

Who can take part?

  • • Ages 50 Years to 75 Years
  • • Diagnosed with alzheimer's disease

Where?

  • • London - Institute of Psychiatry, Psychology and Neuroscience;Department of Old Age Psychiatry
  • • Southampton - Southampton General Hospital
  • • Glasgow - Queen Elizabeth Hospital
  • • London - National Hospital For Neurology and Neurosurgery

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

Alzheimer's Disease

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 50 Years - 75 Years
  • Who can join: All genders

What the study is looking for

  • ✓Willingness and ability to complete all aspects of the study. The participant should be capable of completing...
  • ✓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...
  • ✓If the participant is receiving causing symptoms AD medications, a stable dosing regimen for at least 8 weeks prior to...
  • ✓Agreement not to participate in other research studies for the duration of this study.

Who cannot take part

  • ✗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.'
See the full criteria
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

Where Is This Study? (4 UK sites)

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

London SE5 8AF, United Kingdom

Southampton General Hospital

Southampton SO16 6YD, United Kingdom

Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

Queen Elizabeth Hospital

Glasgow G21 3UW, United Kingdom

Hospital R&D contact (matched)

Tom Dymond

research&development@qehkl.nhs.uk01553 613532

National Hospital For Neurology and Neurosurgery

London WC1N 3BG, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-09