Date: 2016-03-10
Type of information: Clinical trial authorization
phase: 2
Announcement: clinical trial authorization
Company: Anavex Life Sciences (USA - NY)
Product: ANAVEX2-73 (tetrahydro-N,N-dimethyl-2,2-diphenyl-3-furanmethanamine hydrochloride)
Action
mechanism: Anavex2-73 is an agonist of the intracellular sigma-1 chaperone protein. The compound is a mixed muscarinic receptor/sigma 1 ligand. It has been reported to have memory-preserving and neuroprotective effects in mice treated with the muscarinic receptor antagonist scopolamine, with synthetic ABêta oligomer injection, or with the NMDA receptor agonist dizocilpine. A recent study suggested that Anavex 2-73 may block tau hyperphosphorylation.
Disease: Alzheimer's diseased
Therapeutic area: Neurodegenerative diseases
Country: Australia
Trial
details: The multi-center Phase 2a clinical trial of ANAVEX 2-73 consists of an open-label extension for an additional 104 weeks, allowing for the gathering of safety data for ANAVEX 2-73 cumulatively over three years. 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.(NCT02756858)
Latest
news: * On March 10, 2016, Anavex Life Sciences announced that the Company has received the approval from the Ethics Committee in Australia to extend the ongoing Phase 2a Alzheimer’s trial, which had been requested by patients and their caregivers. The trial extension is designed to allow participants who complete 52 weeks in PART B to roll-over into a new trial and continue taking ANAVEX 2-73 for an additional 104 weeks, providing an opportunity to gather extended safety and efficacy data. The trial is independent of the Company’s planned larger Phase 2/3 double-blinded, placebo-controlled study of ANAVEX 2-73 in Alzheimer’s disease.
