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

NCT03174886 Phase 1 UNKNOWN

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.

Details

Lead sponsor	Axon Neuroscience SE
Phase	Phase 1
Status	UNKNOWN
Enrolment	33
Start date	2017-07-31
Completion	2020-11

Conditions

• Primary Progressive Nonfluent Aphasia

Interventions

• AADvac1 40 µg
• AADvac1 160 µg

Primary outcomes

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] — 25 months
  The safety assessment is based on the number, type and severity of adverse events (AEs).
• Immunogenicity (Percentage of patients who develop an IgG immune response, geometric mean titre of titre of antibodies against Axon Peptide 108, IgG to IgM ratio of antibodies against Axon Peptide 108) — 24 months
  AADvac1 depends on raising antibodies that mediate its treatment effects. Immunogenicity assessment includes: Percentage of AADvac1-treated patients who develop an immune response (responder rate), geometric mean titre of antibodies against Axon Peptide 108, IgG to IgM ratio of antibodies against Axon Peptide 108.

Countries

Germany