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NCT05256134 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Gantenerumab in Participants at Risk for or at the Earliest Stages of Alzheimer's Disease (AD)
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 3
- Development phase
- 25
- Enrollment target
NCT05256134: Clinical Trial Phase 3 study, sponsored by Hoffmann-La Roche.
NCT05256134 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 25 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05256134, a Phase 3 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 25 participants
- Enrollment target
Study Summary
A study to evaluate the efficacy and safety of gantenerumab in amyloid-positive, cognitively unimpaired participants at risk for or at the earliest stages of AD. The planned number of participants for this study is approximately 1200 participants randomized in a 1:1 ratio to receive either gantenerumab or placebo (600 participants randomized to gantenerumab and 600 participants randomized to placebo).
Primary Outcome
The PACC-5 is computed as the average of z-scores of the following cognitive measures: 1. Wechsler Memory Scale (WMS LM I-II) - Total Score LM II Delayed Recall; 2. Free \& Cued Selective Reminding Test (FCSRT) -Immediate and Delayed Recall - Trials 1-3: Total Recall; 3. Wechsler Adult Intelligence Scale (WAIS) - IV Coding - Total Raw Score; 4. Mini Mental State Examination (MMSE) - Total Score; 5. Category Fluency Test (CFT) - 3 categories - Vegetables, Fruits and Animals - Total Admissible Wor
Interventions
- DRUG Placebo
- DRUG Gantenerumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2022-04-19 |
| Est. Completion | 2023-03-13 |
| Phase | Phase 3 |
Why NCT05256134 stopped before completion
NCT05256134 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05256134 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05256134 about?
NCT05256134 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Gantenerumab in Participants at Risk for or at the Earliest Stages of Alzheimer's Disease (AD)". A study to evaluate the efficacy and safety of gantenerumab in amyloid-positive, cognitively unimpaired participants at risk for or at the earliest stages of AD. The planned number of participants for this study is approximately 1200 participants randomized in a 1:1 ratio to receive either ganteneru...
What is the current status of trial NCT05256134?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 25 participants. The study started on 2022-04-19. Estimated completion is 2023-03-13.
What interventions are being tested in trial NCT05256134?
The interventions under investigation include: Placebo (DRUG), Gantenerumab (DRUG).
Who is sponsoring clinical trial NCT05256134?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05256134's enrollment target sits among peer trials
25 1941st of 2000 higher than 58 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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