NCT02579252

24 Months Safety and Efficacy Study of AADvac1 in Patients With Mild Alzheimer's Disease

A 24 Months Randomised, Placebo-controlled, Parallel Group, Double Blinded, Multi Centre, Phase 2 Study to Assess Safety and Efficacy of AADvac1 Applied to Patients With Mild Alzheimer's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: Axon Neuroscience SE · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the safety and efficacy of AADvac1 in the treatment of patients with mild Alzheimer's disease. 60% of participants will receive AADvac1 and 40% of participants will receive placebo.

Detailed description

Alzheimer's disease (AD) 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. Currently available treatments are designed to compensate for the neurotransmitter loss caused by the disease without affecting the disease process itself. AADvac1 is designed to raise antibodies against pathological tau protein (the primary constituent of neurofibrillary pathology in AD). 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

• Alzheimer's Disease

Interventions

Type	Name	Description
BIOLOGICAL	AADvac1
DRUG	Placebo

Timeline

• Start date: 2016-03-01
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2015-10-19
• Last updated: 2019-11-14

Locations

42 sites across 8 countries: Austria, Czechia, Germany, Poland, Romania, Slovakia, Slovenia, Sweden