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NCT07234942Active, not recruitingPhase 1

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

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 Following Intrathecal Administration in Participants With Early Symptomatic Alzheimer's Disease

Source: ClinicalTrials.gov · Last updated 9 Sept 2026

Brief summary (registry, in English)

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

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
6 (actual)
First submitted
14 Nov 2025
Start date
27 Jan 2026
Primary completion date
31 Mar 2027
Lead sponsor
Hoffmann-La Roche
NCT number
NCT07234942
EU CT number
2025-522101-37-00

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 6
  • From 27 Jan 2026 to the primary completion date, 31 Mar 2027
  • 16 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

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

Other

  • 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

Who the study is looking for

  • 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.

Age in the registry: 50 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (16)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Montreal Neurological Institute Clinical Research Unit
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
Toronto Western Hospital
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TorontoCanadaUnknown status
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainCompleted
Fundació ACE, Institut Català de Neurociències Aplicades
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BarcelonaSpainCompleted
Hospital Universitario Reina Sofia
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CórdobaSpainCompleted
Hospital Universitari General de Catalunya
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Sant Cugat del VallèsSpainCompleted
Queen Elizabeth Hospital
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GlasgowUnited KingdomUnknown status
National Hospital For Neurology and Neurosurgery
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Institute of Psychiatry, Psychology and Neuroscience;Department of Old Age Psychiatry
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Southampton General Hospital
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SouthamptonUnited KingdomUnknown status
Brain Research Center Amsterdam B.V.
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AmsterdamNetherlandsCompleted
Revit Sp. z o.o.
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BialystokPolandCompleted
Krakowska Akademia Neurologii Sp. z o.o.
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CracowPolandCompleted
Centrum Medyczne NeuroProtect
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WarsawPolandCompleted
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
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GoteborgSwedenRecruiting
Karolinska University Hospital
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HuddingeSwedenRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.