MedTrace Logo

A Study of a Potential Disease Modifying Treatment in Individuals at Risk for or With a Type of Early Onset AD Caused by a Genetic Mutation

NCT06647498 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2026-02-13

No results posted yet for this study

Summary

The purpose of this research study is to test the study drug, referred to as remternetug, to determine its effectiveness for the study treatment of asymptomatic (at risk) Alzheimer disease in individuals with AD-causing mutations. This study will also investigate the effects of remternetug on biomarkers (measures of the disease including brain scans, blood and spinal fluid tests), examine safety data to identify any potential benefits or risks, and examine how well participants can tolerate remternetug.

Stage 1 will determine if treatment with the study drug prevents or reverses amyloid beta (Aβ) accumulation compared with placebo in participants with dominantly inherited Alzheimer's disease (DIAD).

Stage 2 will evaluate the effect of early anti-amyloid treatment on downstream biomarkers of AD in treated participants compared to external control groups.

Conditions

  • Alzheimers Disease
  • Dementia
  • Alzheimers Disease, Familial

Interventions

DRUG

Remternetug

Administered subcutaneously every 12 weeks

DRUG

Matching Placebo (Remternetug)

Administered as subcutaneous injection of placebo every 12 weeks

Sponsors & Collaborators

  • Alzheimer's Association

    collaborator OTHER

  • Eli Lilly and Company

    collaborator INDUSTRY

  • National Institute on Aging (NIA)

    collaborator NIH

  • GHR Foundation

    collaborator UNKNOWN

  • Private Donors

    collaborator UNKNOWN

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Eric M McDade, DO · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-22
Primary Completion
2034-03-31
Completion
2034-08-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Canada
  • Colombia
  • France
  • Germany
  • Italy
  • Mexico
  • Netherlands
  • New Zealand
  • Puerto Rico
  • Spain
  • United Kingdom

Study Locations

More Related Trials

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 NCT06647498 on ClinicalTrials.gov