RO7812653 for people with early symptomatic Alzheimer's disease
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
This study will test whether RO7812653 is safe and how it acts in people with early symptomatic Alzheimer's disease.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 50 Years to 75 Years |
| Sex | All |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Locations | 6 sites (Amsterdam, North Holland and 5 other locations) |
| Trial ID | NCT07234942 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1 interventional study sponsored by Hoffmann‑La Roche that administers RO7812653 or placebo to people with early symptomatic Alzheimer's disease to characterize safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics. Participants who meet clinical criteria for probable AD dementia or MCI due to AD will receive the investigational agent or placebo and be followed with clinical exams, neuropsychological testing, and laboratory sampling. The study will monitor adverse events, immune responses, drug levels in blood, and pharmacodynamic markers to guide dosing and future development. Sites include academic centers in the Netherlands and Sweden.
Who should consider this trial
Good fit: Adults with early symptomatic Alzheimer's disease (probable AD dementia or MCI due to AD) who can complete study assessments, speak the site language, and maintain stable symptomatic AD medications are eligible.
Not a fit: People with advanced Alzheimer's, those unable to complete neuropsychological testing, those with unstable AD medications, or those unable to attend study visits likely will not benefit from participation.
Why it matters
Potential benefit: If successful, RO7812653 could lead to a new therapeutic approach that slows disease progression or improves symptoms in early Alzheimer's disease.
How similar studies have performed: Related approaches targeting Alzheimer's disease biology have shown mixed results in prior trials, so this approach has some precedent but remains exploratory.
Eligibility criteria
Show full inclusion / exclusion 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 this trial is running
Amsterdam, North Holland and 5 other locations
- Brain Research Center Amsterdam — Amsterdam, North Holland, Netherlands (Recruiting)
- Sahlgrenska Universitetssjukhuset — Mlndal, Sweden (Recruiting)
- Karolinska Universitetssjukhuset — Solna, Sweden (Recruiting)
- Institute of Psychiatry, Psychology and Neuroscience;Department of Old Age Psychiatry — London, Greater London, United Kingdom (Recruiting)
- Southampton General Hospital — Southampton, Hampshire, United Kingdom (Recruiting)
- National Hospital For Neurology and Neurosurgery — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Reference Study ID Number: BP45770 https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. and Canada)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.