Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06384573
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-04-22
Brief Title:
DIAN-TU Amyloid Removal Trial ART in Dominantly Inherited Alzheimers Disease
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
The Dominantly Inherited Alzheimer Network Trials Unit DIAN-TU Amyloid Removal Trial ART A Phase IIIbIV Open-Label Study of Lecanemab to Evaluate Prevention and Progression of Dominantly Inherited Alzheimers Disease
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIAN-TU
Brief Summary:
This is an open label study to treat dominantly inherited Alzheimers disease DIAD mutation carrier participants from the DIAN-TU-001 gantenerumab Open Label Extension OLE period with lecanemab to determine the effects of amyloid removal on age of onset and clinical progression compared to external controls if amyloid plaque as measured by amyloid PET can be fully removed in DIAD and the effects of amyloid removal on biomarkers of disease progression
Detailed Description:
The Dominantly Inherited Alzheimer Network DIAN and the DIAN Trials Unit DIAN-TU have established a global network that has increased understanding of Alzheimers disease AD and identified a reliable cohort of individuals available for clinical trials Over the past 12 years the DIAN-TU has conducted a trial with the monoclonal antibody gantenerumab DIAN-TU-001 providing the longest treatment period for individuals with amyloid removing immunotherapies trial launched in December 2012 double-blind readout in 2019 currently completing the open-label extension OLE in 2024 Notably efficacy and safety outcomes of the DIAN-TU and other trials with dominantly inherited AD DIAD populations have predicted and were concordant with sporadic AD sAD trials in several programs
The DIAN-TU-001 gantenerumab OLE period has reached the end of participation and there is an urgent need to launch a trial that will allow for the continued amyloid removal treatment and monitoring of these uniquely informative individuals The range of exposure duration in these individuals to gantenerumab is large 2 to 10 years Because there are a substantial number of participants that are approaching the estimated age that AD symptoms develop it is critical to continue to monitor and treat these individuals to identify whether robust amyloid reduction prior to symptom onset can provide significant delay in disease progression
In summary the main reason for conducting this study is to gather key data to answer important outstanding scientific and clinical care questions for dominantly inherited AD and sporadic AD These include improved insights into efficacy-related questions regarding drug dose and duration mechanism of action target population and target disease stage that results in optimal benefit to patients An evaluation of the long-term effects of amyloid removal on disease progression in DIAD could provide the first proof of concept that removing amyloid years before symptom onset could have major effects in delaying symptom onset by years and to provide estimates for the relative effect sizes by years to symptom onset Additionally this study could provide the first evidence that patients can be treated with mechanistically different amyloid removing drugs to achieve full amyloid removal Together these insights could offer guidance as to how clinicians can use lecanemab a monoclonal antibody passive immunotherapy in the era of multiple available amyloid removing treatments
Participants in this trial will be co-enrolled in the DIAN Observational Study DIAN Obs NCT00869817 DIAN Obs represents a unique translational study in AD research that has provided transformational data-driven models of the sequence of biomarkers abnormalities in preclinical DIAD DIAN Obs is the largest longitudinal multi-national study tracking DIAD families using a uniform protocol To maximize the efficiency and utility of the DIAN Obs the study introduced several efficiencies including 1 harmonizing protocols with the DIAN-TU 2 applying International Conference on Harmonization Good Clinical Practice ICH GCP standards and a global unique identifier GUID at all performance sites to facilitate data sharing between all DIAN studies Annual assessments will be performed for this population to collect clinical and cognitive data amyloid and tau PET imaging and cerebrospinal fluid CSF and plasma biomarkers for primary and secondary outcomes
The DIAN-TU-001 gantenerumab OLE period has reached the end of participation and there is an urgent need to launch a trial that will allow for the continued amyloid removal treatment and monitoring of these uniquely informative individuals The range of exposure duration in these individuals to gantenerumab is large 2 to 10 years Because there are a substantial number of participants that are approaching the estimated age that AD symptoms develop it is critical to continue to monitor and treat these individuals to identify whether robust amyloid reduction prior to symptom onset can provide significant delay in disease progression
In summary the main reason for conducting this study is to gather key data to answer important outstanding scientific and clinical care questions for dominantly inherited AD and sporadic AD These include improved insights into efficacy-related questions regarding drug dose and duration mechanism of action target population and target disease stage that results in optimal benefit to patients An evaluation of the long-term effects of amyloid removal on disease progression in DIAD could provide the first proof of concept that removing amyloid years before symptom onset could have major effects in delaying symptom onset by years and to provide estimates for the relative effect sizes by years to symptom onset Additionally this study could provide the first evidence that patients can be treated with mechanistically different amyloid removing drugs to achieve full amyloid removal Together these insights could offer guidance as to how clinicians can use lecanemab a monoclonal antibody passive immunotherapy in the era of multiple available amyloid removing treatments
Participants in this trial will be co-enrolled in the DIAN Observational Study DIAN Obs NCT00869817 DIAN Obs represents a unique translational study in AD research that has provided transformational data-driven models of the sequence of biomarkers abnormalities in preclinical DIAD DIAN Obs is the largest longitudinal multi-national study tracking DIAD families using a uniform protocol To maximize the efficiency and utility of the DIAN Obs the study introduced several efficiencies including 1 harmonizing protocols with the DIAN-TU 2 applying International Conference on Harmonization Good Clinical Practice ICH GCP standards and a global unique identifier GUID at all performance sites to facilitate data sharing between all DIAN studies Annual assessments will be performed for this population to collect clinical and cognitive data amyloid and tau PET imaging and cerebrospinal fluid CSF and plasma biomarkers for primary and secondary outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| The Alzheimers Association | OTHER_GRANT | DIAN-TU-OLE-21-725093 | None |