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O4‐04‐03: Additional results from a phase ii study to assess the clinical and immunological activity, safety, and tolerability of affitope® ad02 in patients with early Alzheimer's disease (AD)
Author(s) -
Schneeberger Achim,
Hendrix Suzanne,
Ellison Noel,
Bürger Vera,
Dubois Bruno
Publication year - 2015
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2015.07.365
Subject(s) - medicine , tolerability , placebo , clinical endpoint , clinical trial , gastroenterology , adverse effect , pathology , alternative medicine
-23%, and -60%). For the combination drug treatment arms, we observed a significant broad dose response in the presence of high dose antibody and varying dose levels of BACE inhibitor (from -33% through -84%). The combination drug treatments of a high dose BACE inhibitor in the presence of varying dose levels of Ab antibody revealed a significant, yet steeper dose response (from -60% through -84%). Several of the of drug combination treatments resulted in significant synergistic lowering of deposited Ab. The longitudinal study demonstrated significant time dependent effects on plaque removal that was detected as early as 4weeks and the combination therapy showed a continual significant reduction over time that resulted in a dramatic reduction of deposited Ab as compared to the time zero cohort. Conclusions: The combination therapy studies demonstrated significant dose-response and longitudinal relationships for the plaque specific antibody and BACE inhibitor that further support/enable the rationale for utilizing combinational anti-amyloid therapies in the clinic.