CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 194 enrolled
Drug / intervention
Gantenerumab +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04623242
NCT04623242Phase 3Completed

A Phase II/III Randomized, Double-Blind, Placebo-Controlled, Cognitive Endpoint, Multi-Center Study of Potential Disease Modifying Therapies in Individuals at Risk for and With Dominantly Inherited Alzheimer's Disease

Washington University School of Medicine·interventional·Posted Nov 10, 2020·Updated Sep 22, 2022

In Brief

A Phase 3 clinical trial evaluating Gantenerumab, Solanezumab, and 2 other interventions for Alzheimers Disease and 2 related conditions. Completed, enrolled 194 participants across 25 sites in 8 countries.

Detailed Summary

The purpose of this study is to assess the safety, tolerability, biomarker and cognitive efficacy of investigational products in subjects who are known to have an Alzheimer's disease-causing mutation by determining if treatment with the study drug slows the rate of progression of cognitive impairment and improves disease-related biomarkers. This is an analysis study for an MPRP: DIAN-TU-001 Master NCT01760005

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, France, Ireland, Puerto Rico, Spain, United Kingdom, United States

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 10, 2020
Enrollment StartDec 1, 2012
Primary CompletionNov 22, 2019
Study CompletionMar 6, 2020
TodayJul 2, 2026
Enrollment to primary: 7.0 yearsPosted 5.6 years ago

Interventions

Gantenerumabdrug

Subcutaneously every 4 weeks at escalating doses

Solanezumabdrug

Intravenous infusion every 4 weeks at escalating doses

Matching Placebo (Gantenerumab)drug

Subcutaneous injection of placebo every 4 weeks

Matching Placebo (Solanezumab)drug

Intravenous infusion of placebo every 4 weeks