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 Alzheimer's Disease Caused by a Genetic Mutation — DIAN-TU  

Dementia Clinical Trial

Official title: A Phase II/III Multicenter Randomized, Double-Blind, Placebo-Controlled Platform Trial of Potential Disease Modifying Therapies Utilizing Biomarker, Cognitive, and Clinical Endpoints in Dominantly Inherited Alzheimer's Disease

Status Terminated

Clinical Trial Summary

The purpose of this study is to assess the safety, tolerability, biomarker, cognitive and clinical efficacy of investigational products in participants with an Alzheimer's disease-causing mutation by determining if treatment with the study drug slows the rate of progression of cognitive/clinical impairment or improves disease-related biomarkers.

Clinical Trial Description

Alzheimer's disease (AD) is defined by the presence of abnormal accumulations of amyloid protein (plaques) and tau protein (tangles) in the brain. The double-blind arm of DIAN-TU-001 Master protocol (NCT01760005) tested whether gantenerumab provided a clinical benefit by slowing the onset or the worsening of the disease. A clinical benefit was not observed in the double-blind part of the DIAN-TU-001 study. However, gantenerumab was associated with improvements in measures of amyloid and tau and an improvement in an overall measure of neurodegeneration (when nerve cells in the brain lose function over time). It is not known whether these changes may provide future clinical benefits. Based on this information, 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 gantenerumab / solanezumab double-blind arm of the Master protocol (NCT01760005), 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 Alzheimer's 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. ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimers Disease
• Alzheimers Disease, Familial
• Dementia

• NCT number: NCT06424236
• Study type: Interventional
• Source: Washington University School of Medicine
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: June 30, 2020
• Completion date: November 13, 2023