4 results
Assess the effect of 2 doses (10 and 20 mg) dronabinol on driving performance compared to placebo in light and heavy cannabis users. The heavy users are used as a model for chronic use of dronabinol.
Part 1PrimaryTo assess dose limiting toxicities (DLTs) of EDR to select an RP3D for the combination to be used in Part 2 of this study.Secondary• To evaluate the overall safety profile of EDR to select an RP3D for the combination to be used in Part…
Primary objective:To continue assessing the safety and tolerability of ANAVEX2-73.Safety and Tolerability Measures:* Physical examination* Vital signs (heart rate, respiratory rate, systolic blood pressure [SBP], diastolic blood pressure [DBP],…
Primary Objectives:* Change from baseline to week 48 in cognition according to the Alzheimer Disease Assessment Scale-Cognition (ADAS-Cog) compared to placebo.* Changes from baseline to week 48 in ability to perform daily activities according to the…