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Monoclonal Antibodies

Gantenerumab for Dementia (DIAN-TU Trial)

Phase 2 & 3
Waitlist Available
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 52, 104, 156, 208 and 260

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

Eligible Conditions
  • Dementia
  • Alzheimer's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 52, 104, 156, 208 and 260
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 52, 104, 156, 208 and 260 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cause of Death
Secondary study objectives
Gantenerumab: Imaging Measures Composite [11C] PiB Partial Volume Corrected Regional Spread Function Standardized Uptake Value Ratio - Composite
Gantenerumab: Rate of Change Over Time- Clinical Dementia Rating Sum of Boxes (CDR-SB)
Gantenerumab: Rate of Change Over Time- Functional Assessment Scale (FAS)
+39 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: SolanezumabExperimental Treatment1 Intervention
Group II: GantenerumabExperimental Treatment1 Intervention
Group III: Matching Placebo (Solanezumab)Placebo Group1 Intervention
Group IV: Matching placebo (Gantenerumab)Placebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Solanezumab
Not yet FDA approved
Gantenerumab
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Alzheimer's AssociationOTHER
96 Previous Clinical Trials
42,105 Total Patients Enrolled
34 Trials studying Dementia
32,366 Patients Enrolled for Dementia
Hoffmann-La RocheIndustry Sponsor
2,450 Previous Clinical Trials
1,095,358 Total Patients Enrolled
5 Trials studying Dementia
988 Patients Enrolled for Dementia
Accelerating Medicines Partnership (AMP)OTHER
2 Previous Clinical Trials
687 Total Patients Enrolled
2 Trials studying Dementia
687 Patients Enrolled for Dementia
~15 spots leftby Oct 2025
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