ANAVEX2-73 for Treatment of Early Alzheimer's Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Alzheimer Disease
- Type
- Interventional
- Phase
- Phase 2Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized 1:1:1 to two different ANAVEX2-73 doses or placeboMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: There will be blinding procedures for this study. Capsules will be indistinguishable from active ingridient containing capsules.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 60 years and 85 years
- Gender
- Both males and females
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 partici...
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.
Tracking Information
- NCT #
- NCT03790709
- Collaborators
- Anavex Australia Pty Ltd.
- Anavex Germany GmbH
- Anavex Canada Ltd.
- Investigators
- Not Provided
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