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

Lead sponsor

Hoffmann-La Roche

Asset

RO7812653

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•MCI due to AD•Study partner/caregiver required

Primary endpoints

•Adverse Events•Columbia-Suicide Severity Rating Scale (C-SSRS) Scores

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Ctis2025-522101-37-00

Org study IDBP45770

NCT IDNCT07234942

Timeline

Milestones

Study first posted2025-11-19actual

Study start2026-01-27actual

Last update posted2026-06-30actual

Primary completion2028-04-19estimated

Study completion2030-03-05estimated

Assets

Drug assets

RO7812653

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Behavior / neuropsychiatric

Fluid / digital biomarkers

Other (unclassified)