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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.

NCT04623242 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2022-09-22

Study results available
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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

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

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

  • 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
2019-11-22
Completion
2020-03-06

Countries

  • United States
  • Australia
  • Canada
  • France
  • Ireland
  • Puerto Rico
  • Spain
  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04623242 on ClinicalTrials.gov