The statement below is in response to questions and concerns from sites and participants regarding the status of the DIAN-TU-001 gantenerumab open label extension (OLE) study and next steps in the study.
As stated in a previous announcement, although Roche announced its decision to discontinue the company’s clinical trials of gantenerumab in sporadic Alzheimer’s disease (AD), and the DIAN-TU decided to pause the DIAN-TU-002 Primary Prevention Trials with gantenerumab, dosing in the DIAN-TU-001 gantenerumab OLE has continued [Clinicaltrials.gov #NCT01760005] as designed. Gantenerumab is still under study for dominantly inherited AD (DIAD), and there is ample drug available for the DIAN-TU-001 OLE trial.
As also noted in another announcement, the DIAN-TU is continuing the OLE for multiple reasons:
- The Roche GRADUATE trials were conducted in sporadic AD, not DIAD, and it is possible that treatment outcomes from gantenerumab may be different in DIAD because DIAD is known to be caused by mutations in amyloid-beta processing.
- The DIAN-TU trials include individuals that have no symptoms of AD and may provide an opportunity to test the effect of gantenerumab on preventing symptom onset.
- The DIAN-TU-001 OLE is testing a much higher dose of gantenerumab than was tested in the GRADUATE trials and includes participants who will have been treated for 7-10 years, much longer than the GRADUATE I and II studies, providing an opportunity to test higher doses and longer treatment.
The DIAN-TU-001 gantenerumab OLE protocol provides 3 years of treatment with gantenerumab for each participant. The last participant will reach 3 years of treatment in June 2024. However, many participants will be reaching 3 years of treatment sooner and have expressed concerns about discontinuation of treatment with gantenerumab. The DIAN-TU is actively working on trial designs for the DIAN-TU-001 OLE participants after the trial ends (June, 2024). To help ease concerns about a break in treatment, it is important to note that the drug remains in the person’s body (i.e. keeps working) at decreasing concentrations for as long as 6 months after the last dosing. In addition, the drug’s effect of brain amyloid removal likely lasts many years after the last dose based on observations in other studies. Lastly, it takes many years for amyloid deposits in plaques to accumulate in the brain.
We recognize and truly appreciate the commitment of the participants and their families, and we remain committed to them and to finding a treatment for this disease. We will continue to provide updates as we identify opportunities and finalize future plans for the DIAN-TU-001 gantenerumab OLE participants.
MOD01644143