NCT03790709

ANAVEX2-73 for Treatment of Early Alzheimer's Disease

A Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled 48-week Safety and Efficacy Trial of ANAVEX2-73 for the Treatment of Early Alzheimer's Disease (AD)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 509 (actual)
• Sponsor: Anavex Life Sciences Corp. · Industry
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Phase 2b/3 48-week study to evaluate the effects of ANAVEX2-73 on cognition and function after 48 weeks of daily treatment. Additional outcome measures include refined measures of sleep, behavioral and psychological symptoms typically observed in AD, changes in daily functioning of participants and changes in caregiver burden, as well as changes in quality of life measures of both, patients and caregivers during treatment with ANAVEX2-73.

Detailed description

This is a Phase 2b/3 48-week study to evaluate the effects of ANAVEX2-73 on cognition and function after 48 weeks of daily treatment. Additional outcome measures include refined measures of sleep, behavioral and psychological symptoms typically observed in AD, changes in daily functioning of participants and changes in caregiver burden, as well as changes in quality of life measures of both, patients and caregivers during treatment with ANAVEX2-73. In addition, safety assessments, pharmacokinetic (PK) assessments and collections of CSF and blood markers of AD pathophysiology before and after treatment will be performed.

Conditions

• Alzheimer Disease

Interventions

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

Timeline

• Start date: 2018-07-03
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2019-01-02
• Last updated: 2022-07-14

Locations

54 sites across 5 countries: Australia, Canada, Germany, Netherlands, United Kingdom