- Phase 2a is a simple, open-label, randomized, cross-over between oral (30mg/50mg) and IV (3mg/5mg) administration, two-period, lasting up to five weeks for each patient.
- Phase 2b an open-label extension study for 52 weeks. This phase was initially planned for 26 weeks, and extended at the request of AD patients and caregivers.
Anavex Life Sciences Corp. reported that a positive dose-response relationship has been observed in its ongoing Phase 2a clinical trial of ANAVEX 2-73 as a potential treatment for mild-to-moderate Alzheimer’s disease (AD). The announcement came as part of a planned, interim study analysis. The ANAVEX 2-73 Phase 2a study is a multicenter trial in 32 mild-to-moderate Alzheimer’s patients. The primary endpoint is evaluation of the safety and tolerability of ANAVEX 2-73, an orally available drug candidate that targets sigma-1 and muscarinic receptors. Secondary endpoints include bioavailability, dose response, and exploratory cognitive effects using Mini Mental State Examination (MMSE), Cogstate battery, electroencephalographic (EEG) activity and event-related potentials (ERP), and evaluation of the Alzheimer's Disease Co-operative Study-Activities of Daily Living Inventory (ADSC-ADL). A further secondary endpoint is the evaluation of ANAVEX 2-73 as an add-on therapy to donepezil, the current standard of care. The company reported that the drug was seen to prevent, halt, and even reverse disease course in preclinical studies. The ANAVEX 2-73 trial is divided into two parts: