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An Extension Study of ANAVEX2-73 in Patients With Mild to Moderate Alzheimer's Disease

Phase 2
Completed
Conditions
Alzheimer's Disease
Interventions
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
Inclusion Criteria
  • 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)
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Exclusion Criteria
  • 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)
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
ANAVEX2-73 Oral as assigned in ANAVEX2-73-002ANAVEX2-73-
Primary Outcome Measures
NameTimeMethod
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0Up to 208 weeks

Safety

Secondary Outcome Measures
NameTimeMethod
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

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