First Participant Enrolled in Phase 2/3 Study of AntiTau and Antiamyloid Antibodies for Dominantly Inherited Alzheimer Disease

The first participant has been enrolled in the phase 2/3 Tau NexGen study (NCT04971733) to assess antitau and antiamyloid antibodies for potential treatment of dominantly inherited Alzheimer disease (DIAD). The Tau NexGen study is part of the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU)(NCT01760005).

This novel study will assess an antitau antibody (E2814, Eisai, Woodcliff Lake, NJ) and an antiamyloid antibody, lecanemab (Eisai) in participants with an AD-causing gene mutation. 
Symptomatic participants will be administered lecanemab for 6 months before being randomly assigned to receive the antitau antibody or placebo for the rest of the study. Presymptomatic participants will be randomly assigned to receive the antitau antibody or a placebo for a year before beginning lecanemab administration. Effects of the antitau antibody alone will be assessed before evaluating the results of the 2 drugs together. The study is designed to assess if amyloid removal is needed for an antitau agent to function most effectively.

In the previous study 201 (NCT01767311), participants with early AD had reduction of brain amyloid accumulation (P<.0001) and slowing of disease progression measured by AD composite score (ADCOMS) (P<0.05). The study did not achieve its primary outcome measure at 12 months of treatment. Studies of lecanemab alone for early AD are continuing.