Anavex Life Sciences Corp (AVXL)

[12x]

The OLE link did have the new titration protocol. All patients regardless of their prior dose during the ANAVEX2-73-AD-004 clinical trial will be titrated to 50mg or best tolerated dose over 10 weeks. This is exciting. An opportunity to confirm 50mg halts AD progression over 96 weeks.

Research summary
This is a Phase 2b/3 open-label extension study to evaluate the effects of ANAVEX2-73 on safety and cognition after 96 weeks of daily treatment. Additional outcome measures include measures of function and behavioural symptoms typically observed in AD during treatment with ANAVEX2-73.
The study is limited to subjects who completed the ANAVEX2-73-AD-004 double-blind
clinical study who consent to enrol in the open label study.
All patients regardless of their prior dose during the ANAVEX2-73-AD-004
clinical trial will begin treatment at 10 mg/day ANAVEX2-73 for the first two weeks (Week 0 and Week 1), increasing by 10 mg every two weeks over a 10-week period to a maximum maintenance daily dose of either 50 mg/day or best tolerated dose. Then a maintenance period (Weeks 11-96)of 50 mg/day ANAVEX2-73 or best tolerated dose.
Assessments include: 12 Lead ECG, laboratory blood tests, Urine dipstick, questionnaires (ADAS-Cog, ADCS-ADL, MMSE, ZBI, NPI-Q, QoL-AD, C-SSRS).