Dane, there are some differences in the new 2 year trial. One notable difference is that donepezil is absent from the trial description.
Current trial -
The multicenter Phase 2a clinical trial of ANAVEX 2-73 consists of two parts and a total of 32 mild-to-moderate Alzheimer’s patients. PART A is a simple randomized, open-label, two-period, cross-over, adaptive trial lasting up to 36 days for each patient. PART B is an open-label extension for an additional 52 weeks.
The primary objective of the trial is to evaluate the maximum tolerated dose of ANAVEX 2-73. Secondary trial objectives include exploratory cognitive efficacy using mini-mental state examination score (MMSE), dose response, bioavailability, Cogstate and electroencephalographic (EEG) activity, including event-related potentials (EEG/ERP), as well as the relationship of ANAVEX 2-73 as an add-on therapy to donepezil (Aricept®).
New 2 year trial -
The new 104-week (two-year) extension of the multi-center Phase 2a clinical trial of ANAVEX 2-73 will follow patients with mild-to-moderate Alzheimer’s disease who have already completed 52 weeks in PART B of the study. Every three months, patients will be scheduled for physician visits to assess primary and secondary endpoints.
The primary endpoint of the new Phase 2a trial is to establish continued safety and tolerability of ANAVEX 2-73. Secondary endpoints are exploratory cognitive as well as functional measures using Mini Mental State Examination (MMSE) and evaluation of Alzheimer’s Disease Co-operative Study – Activities of Daily Living Inventory (ADCS-ADL), respectively.
