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. Master Protocol DIAN-TU-001

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.

Conditions

• Alzheimers Disease
• Dementia
• Alzheimers Disease, Familial

Interventions

DRUG

Gantenerumab

Subcutaneously every 4 weeks at escalating doses

DRUG

Solanezumab

Intravenous infusion every 4 weeks at escalating doses

DRUG

Matching Placebo (Gantenerumab)

Subcutaneous injection of placebo every 4 weeks

DRUG

Matching Placebo (Solanezumab)

Intravenous infusion of placebo every 4 weeks

DRUG

Gantenerumab

Open-label administered Subcutaneously every 4 weeks at escalating doses

DRUG

E2814

Administered intravenously in a blinded fashion

DRUG

Lecanemab

Administered intravenously

DRUG

Matching Placebo (E2814)

Placebo administered intravenously in a blinded fashion.

Sponsors & Collaborators

• Eli Lilly and Company

  collaborator INDUSTRY

• Hoffmann-La Roche

  collaborator INDUSTRY

• Alzheimer's Association

  collaborator OTHER

• National Institute on Aging (NIA)

  collaborator NIH

• Avid Radiopharmaceuticals

  collaborator INDUSTRY

• Accelerating Medicines Partnership (AMP)

  collaborator OTHER

• Eisai Inc.

  collaborator INDUSTRY

• Janssen, LP

  collaborator INDUSTRY

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Randall J Bateman, MD · Washington University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-12-31

Primary Completion

2028-04-30

Completion

2028-07-31

Countries

• United States
• Argentina
• Australia
• Brazil
• Canada
• Colombia
• France
• Germany
• Ireland
• Italy
• Japan
• Netherlands
• Puerto Rico
• Spain
• United Kingdom

Study Locations