A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ANAVEX2-73 for Cognitive Impairment in Patients with Parkinson's Disease with Dementia (PDD)
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group, three-arm, 14-week study in PD patients with dementia. The study includes a 2 week Screening / Baseline Observation Period and a 14-week Treatment Period (including a 2 week Titration Period), and a 2-week Safety Follow-Up Period
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
132
Active oral capsule
Active oral capsule
Placebo oral capsule
KaRa MINDS
Macquarie Park, Australia
Cognitive Drug Research (CDR) Computerized Assessment System Continuity of Attention
Change from Baseline to End of Treatment in Continuity of Attention as measured by Cognitive Drug Research (CDR) Computerized Assessment System Continuity of Attention test
Time frame: 14 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Assess the safety and tolerability of ANAVEX2-73 compared to placebo
Time frame: 14 weeks
MDS-UPDRS Part III Total Score (Motor Scores)
Change from baseline to End of Treatment as measured by MDS-UPDRS Part III Total Score (Motor Scores)
Time frame: 14 weeks
SDS-CL-25
Incidence of sleep disorders symptoms (SDS-CL-25)
Time frame: 14 weeks
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