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A 24-month Phase 1 Pilot Study of AADvac1 in Patients With Non Fluent Primary Progressive Aphasia

NCT03174886 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2019-11-14

No results posted yet for this study

Summary

This study is a pilot trial evaluating the safety and immunogenicity of AADvac1 in patients with the non-fluent variant of Primary Progressive Aphasia.

50% of participants will receive the 40 µg dosage of AADvac1 and 50% of participants will receive the 160 µg dosage of AADvac1. No placebo is used.

Conditions

  • Primary Progressive Nonfluent Aphasia

Interventions

DRUG

AADvac1 40 µg

Active immunotherapy against neurofibrillary pathology.

DRUG

AADvac1 160 µg

Active immunotherapy against neurofibrillary pathology.

Sponsors & Collaborators

  • Axon Neuroscience SE

    lead INDUSTRY

Principal Investigators

  • Markus Otto, Prof · Universitat Ulm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-07-31
Primary Completion
2020-11-30
Completion
2020-11-30

Countries

  • Germany

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 NCT03174886 on ClinicalTrials.gov