Status:
Active, No Longer Recruiting
Clinicaltrials.gov identifier:
Sponsor:
Anavex Life Sciences Corp.
Enrollment:
120
Study Design:
The study is double-blind, randomized, placebo-controlled, and multicenter (25 sites). There are three arms, two with active treatment at low and high doses, and placebo, delivered as oral capsules. The trial is recruiting participants over the age of 50, with a MoCA score between 13 and 23.
Rationale:
There are two primary and two secondary outcome measures, all measured at 14 weeks. The primary ones are: 1. Change from baseline to end of treatment in cognitive drug research (CDR) computerized assessment system for Continuity of Attention; and 2. Number of participants with treatment-related adverse events as assessed by CTCAE (com-mon terminology criteria for adverse events) v4.0. Secondary outcomes are: 1. Change from baseline to end of treatment as measured by the MDS-UPDRS part III score (motor scores); and 2. Incidence of sleep disorders symptom checklist (SDS-CL-25).
Comments:
There are three indications under investigation for ANAVEX®2-73 - Rett syndrome, Alzheimer’s disease, and PD, bringing more clinical experience with this drug. The primary cognitive outcome measure is tightly focused on the attention domain. The MoCA score inclusion criterion is a relatively wide range, including both MCI and PDD.
