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Safety Study of AADvac1, a Tau Peptide-KLH-Conjugate Active Vaccine to Treat Alzheimer's Disease

NCT01850238 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-10-12

No results posted yet for this study

Summary

This first-time-in-man study is mainly designed to assess the safety and tolerability of AADvac1 in the treatment of Alzheimer's disease.

AADvac1 is a vaccine directed against pathologically modified Alzheimer tau protein that is the main constituent of neurofibrillary tangles (NFTs), and is intended to be a disease-modifying treatment for Alzheimer's disease, i.e. to halt its progress.

As this study is a Phase I study focused on tolerability and safety, efficacy will be assessed in an exploratory manner.

Conditions

  • Alzheimer Disease

Interventions

BIOLOGICAL

AADvac1

AADvac1 is intended as an active vaccination for disease-modifying treatment of Alzheimer's disease.

OTHER

Placebo

The placebo contains the same buffer and adjuvant as AADvac1, but lacks the API.

Sponsors & Collaborators

  • Axon Neuroscience SE

    lead INDUSTRY

Principal Investigators

  • Reinhold Schmidt, Professor · Medizinische Universität Graz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Austria

Study Locations

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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 NCT01850238 on ClinicalTrials.gov