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

Primary Progressive Nonfluent Aphasia Clinical Trial

Official title: A 24-month Randomised Parallel Group Single-blinded Multi-centre Phase 1 Pilot Study of AADvac1 in Patients With Non Fluent Primary Progressive Aphasia

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

The non-fluent variant of Primary progressive Aphasia (nfvPPA) is a chronic progressive neurodegenerative disorder of the brain. Over the course of the disease, pathological proteins accumulate in the brain, damaging neurons, thus causing them to lose their connections and die.

No treatments are currently available; symptomatic medications are used off-label in nfvPPA.

AADvac1 is designed to raise antibodies against pathological tau protein (the primary constituent of neurofibrillary pathology, which is the underlying cause of disease in ~80% of nfvPPA cases). These antibodies are expected to prevent tau protein from aggregating, to facilitate the removal of tau protein aggregates and prevent the spreading of pathology, slowing or halting the progress of the disease. ;

Related Conditions & MeSH terms

• Aphasia
• Aphasia, Broca
• Aphasia, Primary Progressive
• Frontotemporal Dementia
• Pick Disease of the Brain
• Primary Progressive Nonfluent Aphasia

• NCT number: NCT03174886
• Study type: Interventional
• Source: Axon Neuroscience SE
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 31, 2017
• Completion date: November 2020