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A Study to Evaluate the Safety, Tolerability and Immunogenicity of Tau Targeted Vaccines in Participants With Early Alzheimer's Disease

NCT04445831 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2025-02-14

Study results available
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Summary

This study is a multicenter, double blind, randomized, placebo-controlled study to evaluate the safety, tolerability and immunogenicity of different doses, regimens and combinations of Tau targeted vaccines in participants with early Alzheimer's Disease.

Conditions

Interventions

BIOLOGICAL

ACI-35.030

Administration of a Low dose of ACI-35.030

BIOLOGICAL

ACI-35.030

Administration of a Medium dose of ACI-35.030

BIOLOGICAL

ACI-35.030

Administration of a High dose of ACI-35.030

OTHER

Placebo

Administration of Placebo

BIOLOGICAL

JACI-35.054

Administration of a Low dose of JACI-35.054

BIOLOGICAL

JACI-35.054

Administration of a Medium dose of JACI-35.054

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    collaborator INDUSTRY

  • AC Immune SA

    lead INDUSTRY

Principal Investigators

  • Philip Scheltens, MD · Amsterdam UMC Alzheimer Center de Boelelaan Amsterdam The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-31
Primary Completion
2023-09-05
Completion
2023-09-05

Countries

  • Finland
  • Netherlands
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT04445831 on ClinicalTrials.gov