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

NCT05552157 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2026-02-13

No results posted yet for this study

Summary

The purpose is to evaluate the biomarker effect, safety, and tolerability of investigational study drugs in participants who are known to have an Alzheimer's disease (AD)-causing mutation. Stage 1 will determine if treatment with the study drug prevents or slows the rate of amyloid beta (Aβ) pathological disease accumulation demonstrated by Aβ positron emission tomography (PET) imaging. Stage 2 will evaluate the effect of early Aβ plaque reduction/prevention on disease progression by assessing downstream non-Aβ biomarkers of AD (e.g., CSF total tau, p-tau, NfL) compared to an external control group from the DIAN-OBS natural history study and the DIAN-TU-001 placebo-treated participants.

Conditions

  • Alzheimers Disease
  • Dementia
  • Alzheimers Disease, Familial

Interventions

DRUG

Remternetug (SC)

Administered subcutaneously every 12 weeks

DRUG

Matching Placebo (Remternetug)

Administered as subcutaneous injection of placebo every 12 weeks

Sponsors & Collaborators

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
2034-03-30
Completion
2034-08-30
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 NCT05552157 on ClinicalTrials.gov