An Extension Study of ANAVEX2-73 in Patients With Mild to Moderate Alzheimer's Disease
- Registration Number
- NCT02756858
- Lead Sponsor
- Anavex Life Sciences Corp.
- Brief Summary
This open label extension study is designed to provide continued access to ANAVEX 2-73 for eligible subjects with mild to moderate Alzheimer's Disease who have previously participated in the Anavex sponsored study ANAVEX2-73-002.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
- Previous exposure to ANAVEX2-73 via participation in Phase 2a Study of ANAVEX2-73 Adaptive-Trial-Design With Repeated Doses, MTD Finding, Pharmacodynamic and Bioavailability Evaluation in Patients With Mild to Moderate Alzheimer's Disease With a 12-Month Open Label Follow-Up Period (ANAVEX2-73-002)
- Have not previously participated Phase 2a Study of ANAVEX2-73 Adaptive-Trial-Design With Repeated Doses, MTD Finding, Pharmacodynamic and Bioavailability Evaluation in Patients With Mild to Moderate Alzheimer's Disease With a 12-Month Open Label Follow-Up Period (ANAVEX2-73-002)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ANAVEX2-73 Oral as assigned in ANAVEX2-73-002 ANAVEX2-73 -
- Primary Outcome Measures
Name Time Method Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 Up to 208 weeks Safety
- Secondary Outcome Measures
Name Time Method Score from MMSE (Mini-mental state examination score) Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, 169, 182, 195, 208 Exploratory Efficacy
HAM-D Score (Hamilton Psychiatric Rating Scale for Depression) Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, 169, 182, 195, 208 Exploratory Efficacy
Score from ADCS-ADL (Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory) Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, 169, 182, 195, 208 Exploratory Efficacy
Trial Locations
- Locations (5)
Melbourne Health - The Royal Melbourne Hospital
🇦🇺Melbourne, Victoria, Australia
Nucleus Network- Centre for Clinical Studies
🇦🇺Melbourne, Victoria, Australia
Austin Health - Heidelberg Repatriation Hospital
🇦🇺Melbourne, Victoria, Australia
Caulfield Hospital
🇦🇺Melbourne, Victoria, Australia
St. Vincent's Hospital
🇦🇺Melbourne, Victoria, Australia