A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter, Parallel-Group Study to Investigate the Safety, Tolerability, and the Effect of RO7269162 on Amyloid and Non-Amyloid Disease-Related Biomarkers Following Daily Oral Administration in Participants at Risk for or at the Prodromal Stage of Alzheimer's Disease
New Alzheimer's Drug Trial: RO7269162 for Early Stages
Plain English Summary
A Study to Evaluate the Safety and Biomarker Effects of RO7269162 in Participants at Risk for or at the Prodromal Stage of Alzheimer's Disease (AD) is a Phase 2 clinical trial sponsored by Hoffmann-La Roche studying Alzheimer's Disease. This trial tests a new drug, RO7269162, to see if it's safe and affects brain changes related to Alzheimer's. It's for people who are at risk of Alzheimer's or have very early signs (mild cognitive impairment) and have amyloid plaques in their brain. Participants will take the study drug or a placebo daily for about 1.5 years, with regular check-ups. Alternatives include existing Alzheimer's medications for symptoms or watchful waiting if not participating. The trial aims to enroll 256 participants.
Official Summary
This clinical trial is recruiting people who either are at risk of AD - have build-up of beta-amyloid, but have no clinical symptoms, or with a diagnosis of mild cognitive impairment. People can take part if they have a certain level of plaques (beta-amyloid) in the brain, shown by a positron emission tomography (PET) scan, a medical imaging technique in which tracers are injected to visualize specific pathological processes in the brain. People who take part in this clinical trial (participants) will be given RO7269162 OR placebo for up to about 1 and a half years. The clinical trial team will see them every 3 weeks in the first 3 months and then every 6 weeks until the end of the trial. These hospital visits will include checks to see how the participant responds to the treatment and any side effects they may have. The total time of participation in the clinical trial will be 90 weeks.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are between 18-35 BMI, have early Alzheimer's signs or are at risk, and have confirmed amyloid plaques in your brain via PET scan. You cannot join if you have other conditions affecting memory, serious heart or blood issues, uncontrolled diabetes, or recent immunotherapy treatments. A reliable study partner who sees you often and can report on your condition is required. This trial is studying Alzheimer's Disease, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcomes measure how safe the drug is and whether it can reduce the amount of amyloid plaques in the brain, which are linked to Alzheimer's disease. The specific primary outcome measures are: Incidence of adverse events (AEs) (up to week 72); Change from baseline in brain amyloid load, as measured by amyloid positron emission tomography ( PET) scan (Baseline to Week 72). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.
Why This Trial Matters
This trial is important because it investigates a new treatment that may slow or prevent the progression of Alzheimer's disease in its earliest stages, addressing a significant unmet medical need. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Alzheimer's Disease, where improved treatment options are needed.
Investor Insight
This trial targets the large and growing market for Alzheimer's treatments, with a focus on early intervention, and represents a significant investment in a potentially disease-modifying therapy. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor about the study drug, potential side effects, and what participation involves. Be prepared for regular visits every 3-6 weeks for about 1.5 years, which will include medical checks and possibly brain scans. Ensure your study partner understands their role and can commit to the duration of the trial. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: TRIPLE
- Enrollment: 256 participants
Interventions
- DRUG: RO7269162 — Participants will receive daily doses (one of three dose levels) of RO7269162 for up to 72 weeks.
- DRUG: Placebo — Participants will receive daily doses of placebo for up to 72 weeks.
Primary Outcomes
- Incidence of adverse events (AEs) (up to week 72)
- Change from baseline in brain amyloid load, as measured by amyloid positron emission tomography ( PET) scan (Baseline to Week 72)
Secondary Outcomes
- Change from baseline in Aβ37 in cerebrospinal fluid (CSF) (Baseline to Week 72)
- Change from baseline in Aβ38 in CSF (Baseline to Week 72)
- Change from baseline in Aβ40 in CSF (Baseline to Week 72)
- Change from baseline in Aβ42 in CSF (Baseline to Week 72)
- Change from baseline in Aβ40 in plasma (Baseline to Week 72)
Full Eligibility Criteria
Inclusion Criteria: * Body Mass Index (BMI) between 18 to 35 kg/m\^2 inclusive at screening * Participants must be either cognitively unimpaired or with a diagnosis of MCI due to AD, according to the National Institute on Aging - Alzheimer's Association (NIA - AA) research framework * Clinical Dementia Rating-Global Score (CDR-GS) of 0 or 0.5 * Positive amyloid PET scan based on a cut-off of ≥24 CL units * Availability of a person (referred as a "study partner" throughout the protocol) who: (a) has frequent and sufficient contact (e.g., minimum twice a week in-person, via telephone, video calls, by e-mail or other electronic means) with the participant, and is willing and able to provide accurate information regarding the participant's cognitive and functional abilities, signs the necessary ICF(s), and has sufficient cognitive capacity to accurately report on the participant's cognitive and functional abilities; (b) is in sufficient good general health to have a high likelihood of maintaining the same level of interaction with the participant and participation in study procedures throughout the duration of the study; and (c) is fluent in the language of the tests used at the study site. Please note that the study partner does not need to be a family member. Every effort should be made to keep the same study partner throughout the study * In case of treatment with symptomatic AD medications, dosing regimen must be stable for at least eight weeks prior to baseline Exclusion Criteria: * Any medical history or evidence of a condition other than AD that may affect cognition * History or presence of significant cardiovascular conditions and/or significant hematological disease * History or presence of chronic kidney disease and/or impaired hepatic function * Uncontrolled/poorly controlled diabetes * History of or active inflammatory bowel disease * Have received any passive or active immunotherapy (immunoglobulin) or other long-acting biologic agent that is under evaluation or approved to prevent or postpone cognitive decline administered within 1 year prior to baseline, and/or any other investigational treatment within five half-lives or 16 weeks prior to screening, whichever is longer
Trial Locations
- Centro de Investigación Clínica UC-CICUC, Santiago, Chile
- Hospital Clinico Univ de Chile, Santiago, Chile
- Aarhus Universitetshospital Skejby, Aarhus N, Denmark
- Rigshospitalet, Hukommelsesklinikken, Koebenhavn Oe, Denmark
- Groupement Hospitalier Est - Hôpital Neurologique, Bron, France
- Hopital B Roger Salengro, Lille, France
- Hôpital de la Timone, Marseille, France
- Hôpital Lariboisière, Paris, France
- CHU de Rouen Hopital, Rouen, France
- Hop Guillaume Et Rene Laennec, Saint-Herblain, France
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT06402838?
NCT06402838 is a Phase 2 INTERVENTIONAL study titled "A Study to Evaluate the Safety and Biomarker Effects of RO7269162 in Participants at Risk for or at the Prodromal Stage of Alzheimer's Disease (AD)." It is currently active, not recruiting and is sponsored by Hoffmann-La Roche. The trial targets enrollment of 256 participants.
What conditions does NCT06402838 study?
This trial investigates treatments for Alzheimer's Disease. The primary condition under study is Alzheimer's Disease.
What treatments are being tested in NCT06402838?
The interventions being studied include: RO7269162 (DRUG), Placebo (DRUG). Participants will receive daily doses (one of three dose levels) of RO7269162 for up to 72 weeks.
What does Phase 2 mean for NCT06402838?
Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.
What is the current status of NCT06402838?
This trial is currently "Active, Not Recruiting." It started on 2024-05-02. The estimated completion date is 2026-11-19.
Who is sponsoring NCT06402838?
NCT06402838 is sponsored by Hoffmann-La Roche. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06402838?
The trial aims to enroll 256 participants. The trial status is active, not recruiting.
How is NCT06402838 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs triple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT06402838?
The primary outcome measures are: Incidence of adverse events (AEs) (up to week 72); Change from baseline in brain amyloid load, as measured by amyloid positron emission tomography ( PET) scan (Baseline to Week 72). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06402838 being conducted?
This trial is being conducted at 20 sites, including Santiago; Aarhus N; Koebenhavn Oe; Bron and 16 more sites (Chile, Denmark, France).
Where can I find official information about NCT06402838?
The official record for NCT06402838 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06402838. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06402838 testing in simple terms?
This trial tests a new drug, RO7269162, to see if it's safe and affects brain changes related to Alzheimer's. It's for people who are at risk of Alzheimer's or have very early signs (mild cognitive impairment) and have amyloid plaques in their brain.
Why is this trial significant?
This trial is important because it investigates a new treatment that may slow or prevent the progression of Alzheimer's disease in its earliest stages, addressing a significant unmet medical need.
What are the potential risks of participating in NCT06402838?
Common side effects may include headaches, dizziness, or nausea. More serious risks, though rare, could involve allergic reactions or specific organ issues, which will be closely monitored. The drug's long-term effects are still being studied. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06402838?
Ask your doctor about the study drug, potential side effects, and what participation involves. Be prepared for regular visits every 3-6 weeks for about 1.5 years, which will include medical checks and possibly brain scans. Ensure your study partner understands their role and can commit to the duration of the trial. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06402838 signal from an investment perspective?
This trial targets the large and growing market for Alzheimer's treatments, with a focus on early intervention, and represents a significant investment in a potentially disease-modifying therapy. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.
What happens if the treatment in this trial doesn't work?
Participants will take the study drug or a placebo daily for about 1.5 years, with regular check-ups. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Alzheimer's Disease Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.