NCT03774459

ANAVEX2-73 Study in Parkinson's Disease Dementia

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Anavex Life Sciences Corp. · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

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

Conditions

• Parkinsons Disease With Dementia

Interventions

Type	Name	Description
DRUG	High dose ANAVEX2-73	Active oral capsule
DRUG	Mid dose ANAVEX2-73	Active oral capsule
DRUG	Placebo oral capsule	Placebo oral capsule

Timeline

• Start date: 2018-07-09
• Primary completion: 2020-09-30
• Completion: 2020-09-30
• First posted: 2018-12-13
• Last updated: 2020-10-22

Locations

25 sites across 2 countries: Australia, Spain