NCT03174886

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

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: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Axon Neuroscience SE · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Primary Progressive Nonfluent Aphasia

Interventions

Type	Name	Description
DRUG	AADvac1 40 µg	Active immunotherapy against neurofibrillary pathology.
DRUG	AADvac1 160 µg	Active immunotherapy against neurofibrillary pathology.

Timeline

• Start date: 2017-07-31
• Primary completion: 2020-11-01
• Completion: 2020-11-01
• First posted: 2017-06-05
• Last updated: 2019-11-14

Locations

3 sites across 1 country: Germany