Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06424236
Status:
TERMINATED
Last Update Posted:
2024-07-03
First Post:
2024-04-16
Brief Title:
Dominantly Inherited Alzheimer Network Trial An Opportunity to Prevent Dementia A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimers Disease Caused by a Genetic Mutation
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
A Phase IIIII Multicenter Randomized Double-Blind Placebo-Controlled Platform Trial of Potential Disease Modifying Therapies Utilizing Biomarker Cognitive and Clinical Endpoints in Dominantly Inherited Alzheimers Disease
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
DIAN-TU announced the discontinuation of the DIAN-TU-001 OLE based on findings from an interim efficacy analysis and the status of the drug program
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIAN-TU
Brief Summary:
The purpose of this study is to assess the safety tolerability biomarker cognitive and clinical efficacy of investigational products in participants with an Alzheimers disease-causing mutation by determining if treatment with the study drug slows the rate of progression of cognitiveclinical impairment or improves disease-related biomarkers
Detailed Description:
Alzheimers disease AD is defined by the presence of abnormal accumulations of amyloid protein plaques and tau protein tangles in the brain The DIAN-TU-001 gantsola double-blind arm NCT04623242 tested whether gantenerumab provided a clinical benefit by slowing the onset or the worsening of the disease Based on information from this an exploratory Open Label Extension OLE will further study the effect of gantenerumab on these Alzheimer-related proteins and their relationship to disease progression
After this final evaluation of study treatment with gantenerumab used in the DIAN-TU-001 gantsola double-blind arm NCT04623242 participants from the double-blind arm known to carry the genetic mutation for AD have been invited to participate in an OLE period to receive active gantenerumab study treatment as part of the DIAN-TU-001 Master protocol The OLE period of the study planned to provide study treatment with gantenerumab for up to 3 years 36 months
This study will continue to collect brain scans blood and spinal fluid tests also called biomarkers as well as cognitive testing The idea is to determine if gantenerumab has favorable effects on these tests as it may prevent or delay the symptoms of AD
Update
Based on the completed studies of gantenerumab in sporadic AD in late 2022 it was decided to determine if dominantly inherited Alzheimers disease DIAD participants in the DIAN-TU-001 OLE study were benefiting from gantenerumab high-dose treatment After evaluation it was decided to discontinue the DIAN-TU-001 gantenerumab OLE
After this final evaluation of study treatment with gantenerumab used in the DIAN-TU-001 gantsola double-blind arm NCT04623242 participants from the double-blind arm known to carry the genetic mutation for AD have been invited to participate in an OLE period to receive active gantenerumab study treatment as part of the DIAN-TU-001 Master protocol The OLE period of the study planned to provide study treatment with gantenerumab for up to 3 years 36 months
This study will continue to collect brain scans blood and spinal fluid tests also called biomarkers as well as cognitive testing The idea is to determine if gantenerumab has favorable effects on these tests as it may prevent or delay the symptoms of AD
Update
Based on the completed studies of gantenerumab in sporadic AD in late 2022 it was decided to determine if dominantly inherited Alzheimers disease DIAD participants in the DIAN-TU-001 OLE study were benefiting from gantenerumab high-dose treatment After evaluation it was decided to discontinue the DIAN-TU-001 gantenerumab OLE
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 |
|---|---|---|---|
| R01AG053267 | NIH | DIAN-TU NG-16-434362 | httpsreporternihgovquickSearchR01AG053267 |
| The Alzheimers Association | OTHER_GRANT | None | None |
| U01AG042791 | NIH | None | None |
| 2013-000307-17 | EUDRACT_NUMBER | None | None |
| R01AG046179 | NIH | None | None |
| REec-2014-0817 | REGISTRY | None | None |
| The Alzheimers Association | OTHER_GRANT | None | None |
| GHR Foundation | OTHER_GRANT | None | None |
| Alzheimers Association | OTHER | None | None |
| The Alzheimers Association | OTHER_GRANT | None | None |
| R56AG053267 | NIH | None | None |
| U01AG059798 | NIH | None | None |