Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01224106 · ClinicalTrials.gov registry record · Phase 3
A Study of Gantenerumab in Participants With Prodromal Alzheimer's Disease
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 799
- Enrollment target
NCT01224106: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT01224106 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 799 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01224106, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 799 participants
- Enrollment target
Study Summary
This multi-center, randomized, double-blind, placebo-controlled parallel-group study will evaluate the effect of gantenerumab (RO4909832) on cognition and functioning and the safety and pharmacokinetics in participants with prodromal Alzheimer's Disease. Participants will be randomized to receive subcutaneous (SC) injections of either gantenerumab or placebo. Participants who consent to be part of the sub study will undergo positron emission tomography (PET) scanning to assess brain amyloid. The anticipated time on study treatment is 104 weeks in Part 1, with an option for an additional up to 2 years of treatment in Part 2, followed by an open-label extension (Part 3) until July 2020. The dosing for Parts 1 and 2 was stopped after a planned futility interim analysis showed a low probability of meeting the primary outcome measure with the doses studied. The study has converted to open-label to investigate higher gantenerumab doses.
Primary Outcome
The CDR (Clinical Dementia Rating) is obtained through semi-structured interviews of participants and informants, and cognitive functioning is rated in six domains of functioning: memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated on a five-point scale of functioning as follows: 0, no impairment; 0.5, questionable impairment; 1, mild impairment; 2, moderate impairment; and 3, severe impairment. The CDR-SOB (Clinical De
Interventions
- DRUG Placebo
- DRUG Gantenerumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 799 participants |
| Start Date | 2010-11-30 |
| Est. Completion | 2020-09-10 |
| Phase | Phase 3 |
What the finished NCT01224106 record still lists
NCT01224106 is an interventional study that assigns participants to a tested intervention. The registered 799 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01224106 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01224106 about?
NCT01224106 is a clinical study titled "A Study of Gantenerumab in Participants With Prodromal Alzheimer's Disease". This multi-center, randomized, double-blind, placebo-controlled parallel-group study will evaluate the effect of gantenerumab (RO4909832) on cognition and functioning and the safety and pharmacokinetics in participants with prodromal Alzheimer's Disease. Participants will be randomized to receive su...
What is the current status of trial NCT01224106?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 799 participants. The study started on 2010-11-30. Estimated completion is 2020-09-10.
What interventions are being tested in trial NCT01224106?
The interventions under investigation include: Placebo (DRUG), Gantenerumab (DRUG).
Who is sponsoring clinical trial NCT01224106?
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 NCT01224106's enrollment target sits among peer trials
799 428th of 2000 higher than 1,573 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00695214 · 800 participants · Phase 2
Drug-Induced Sleep Endoscopy for Upper Airway Evaluation in Obstructive Sleep Apnea
- NCT03048201 · 800 participants · NA
Physica System Total Knee Replacement Registry Study
- NCT03792659 · 800 participants
The EXPLORE MG Registry for Myasthenia Gravis
- NCT03819296 · 800 participants · Phase 1
Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI