A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease (MCI to Mild Dementia Due to AD)
Phase 3 trial tests Trontinemab for early Alzheimer's, seeking 800 participants.
Plain English Summary
A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease is a Phase 3 clinical trial sponsored by Hoffmann-La Roche studying Alzheimers Disease. This trial is testing if a drug called Trontinemab can help people with early symptoms of Alzheimer's disease. It is for individuals experiencing mild cognitive impairment or mild dementia due to Alzheimer's. Participants will receive either Trontinemab or a placebo (inactive substance) through an IV, and will undergo regular assessments for about 18 months. Current alternatives include supportive care, lifestyle changes, and other approved medications that may slow progression but do not reverse damage. The trial aims to enroll 800 participants.
Official Summary
The purpose of this study is to assess the efficacy and safety of trontinemab in participants with early symptomatic Alzheimer's disease (AD) (mild cognitive impairment \[MCI\] to mild dementia due to AD).
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you have early symptomatic Alzheimer's disease (mild cognitive impairment or mild dementia) and evidence of Alzheimer's pathology confirmed by a PET scan or spinal fluid test. You must be able to complete study procedures, have a study partner who can assist, and have a certain score on cognitive tests. You cannot join if you have other conditions affecting cognition, significant brain disease, or unstable medical conditions. The study is for adults, and specific age ranges are not detailed but it targets early symptomatic stages. This trial is studying Alzheimers Disease, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how much the drug slows down the worsening of cognitive and daily function abilities over 72 weeks, indicating its potential to preserve independence and quality of life f The specific primary outcome measures are: Change from baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB) (Baseline - 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 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial is important because it aims to find a new treatment that could slow the progression of Alzheimer's disease in its early stages, addressing a significant unmet medical need. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Alzheimers Disease, where improved treatment options are needed.
Investor Insight
This Phase 3 trial for Trontinemab, targeting the large and growing Alzheimer's market, signals strong investor interest in novel therapies with a potentially high probability of approval if efficacy Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 800 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor about the potential benefits and risks of Trontinemab, what participation involves, and if it's suitable for your specific condition. Be prepared for regular visits, cognitive tests, imaging (like MRI or PET scans), and potentially blood draws or spinal taps. Your study partner will be crucial for reporting on your daily functioning and assisting with study requirements. This trial is currently recruiting participants. 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: QUADRUPLE
- Enrollment: 800 participants
Interventions
- DRUG: Trontinemab — Participants will receive IV trontinemab
- OTHER: Placebo — Participants will receive IV placebo
Primary Outcomes
- Change from baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB) (Baseline - Week 72)
Secondary Outcomes
- Change from baseline through Week 72 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13) (Baseline - Week 72)
- Change from baseline through Week 72 in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) total score and instrumental score (Baseline - Week 72)
- Change from baseline through Week 72 in Integrated Alzheimer's Disease Rating Scale (iADRS) (Baseline - Week 72)
- Change from baseline through Week 72 in Mini-Mental State Examination (MMSE) (Baseline - Week 72)
- Change from baseline in CDR-SB (Baseline up to but excluding Week 72)
Full Eligibility Criteria
Inclusion Criteria: * Willingness and ability to complete all aspects of the study (including MRI, clinical genotyping, and PET imaging or CSF as applicable) for the duration of the study. The participant should be capable of completing assessments either alone or with the help of the study partner * Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted) * Evidence of AD pathological process, as confirmed on amyloid PET scan. A CSF tau181/Aβ42 ratio may be used as an alternative option if amyloid PET is not available * Probable AD dementia or MCI due to AD, also known as an Alzheimer's clinical syndrome clinical Stage 3 or Stage 4 * Screening MMSE score ≥ 22 and CDR-GS of 0.5 or 1.0 * Participant- and/or Informant-reported history of cognitive decline with gradual onset and progression over the last 1 year before screening * A Repeatable Battery for the Assessment of Neuropsychological Status Delayed Memory Index (RBANS DMI) score of 85 or order * Availability of a "study partner" as defined by the protocol Exclusion Criteria: * Any evidence of a condition other than AD that may affect cognition * History or presence of clinically significant cerebrovascular disease * History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system (CNS) trauma * History or presence of clinically significant intracranial mass * MRI evidence of significant cerebral abnormalities or inability to tolerate MRI procedures or contraindication to MRI * Any other medical conditions (e.g., cardiovascular, hepatic, renal disease) which are not stable and adequately controlled or which in the opinion of the investigator could affect the participant's safety in the study or interfere with the study assessments * History of malignancy with the following exceptions: if considered to be cured; malignancies with a negligible risk of metastasis or death
Trial Locations
- Banner Alzheimer?s Institute, Phoenix, Arizona, United States
- Sun Valley Research Center, Inc., Imperial, California, United States
- Healthy Brain Clinic, Long Beach, California, United States
- Oakland Clinical, Oakland, California, United States
- Riverside Clinical, Riverside, California, United States
- Cenexel California Neuroscience Research, LLC, Sherman Oaks, California, United States
- Yale University, New Haven, Connecticut, United States
- JEM Research LLC, Atlantis, Florida, United States
- K2 Medical Research-Winter Garden, Clermont, Florida, United States
- Visionary Investigators Network- Neurology Aventura, Miami, Florida, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT07170150?
NCT07170150 is a Phase 3 INTERVENTIONAL study titled "A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease." It is currently recruiting and is sponsored by Hoffmann-La Roche. The trial targets enrollment of 800 participants.
What conditions does NCT07170150 study?
This trial investigates treatments for Alzheimers Disease. The primary condition under study is Alzheimers Disease.
What treatments are being tested in NCT07170150?
The interventions being studied include: Trontinemab (DRUG), Placebo (OTHER). Participants will receive IV trontinemab
What does Phase 3 mean for NCT07170150?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT07170150?
This trial is currently "Recruiting." It started on 2025-11-12. The estimated completion date is 2028-06-07.
Who is sponsoring NCT07170150?
NCT07170150 is sponsored by Hoffmann-La Roche. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07170150?
The trial aims to enroll 800 participants. The trial is currently recruiting and accepting new participants.
How is NCT07170150 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs quadruple 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 NCT07170150?
The primary outcome measures are: Change from baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB) (Baseline - Week 72). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07170150 being conducted?
This trial is being conducted at 20 sites, including Phoenix, Arizona; Imperial, California; Long Beach, California; Oakland, California and 16 more sites (United States).
Where can I find official information about NCT07170150?
The official record for NCT07170150 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07170150. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07170150 testing in simple terms?
This trial is testing if a drug called Trontinemab can help people with early symptoms of Alzheimer's disease. It is for individuals experiencing mild cognitive impairment or mild dementia due to Alzheimer's.
Why is this trial significant?
This trial is important because it aims to find a new treatment that could slow the progression of Alzheimer's disease in its early stages, addressing a significant unmet medical need. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT07170150?
Potential side effects may include infusion-related reactions, headaches, and dizziness. There is a risk of amyloid-related imaging abnormalities (ARIA), which can include swelling or microbleeds in the brain, usually asymptomatic but sometimes requiring monitoring. As this is a placebo-controlled trial, some participants may receive a placebo and not experience the potential benefits of the active drug. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07170150?
Ask your doctor about the potential benefits and risks of Trontinemab, what participation involves, and if it's suitable for your specific condition. Be prepared for regular visits, cognitive tests, imaging (like MRI or PET scans), and potentially blood draws or spinal taps. Your study partner will be crucial for reporting on your daily functioning and assisting with study requirements. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07170150 signal from an investment perspective?
This Phase 3 trial for Trontinemab, targeting the large and growing Alzheimer's market, signals strong investor interest in novel therapies with a potentially high probability of approval if efficacy This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participants will receive either Trontinemab or a placebo (inactive substance) through an IV, and will undergo regular assessments for about 18 months. 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.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.