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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02756858
• Other study ID #: ANAVEX2-73-003
• Status: Completed
• Phase: Phase 2
• Start date: March 2016
• Est. completion date: November 2020

Study information

• Verified date: January 2021
• Source: Anavex Life Sciences Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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)

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)

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• ANAVEX2-73

Locations

Country	Name	City	State
Australia	Austin Health - Heidelberg Repatriation Hospital	Melbourne	Victoria
Australia	Caulfield Hospital	Melbourne	Victoria
Australia	Melbourne Health - The Royal Melbourne Hospital	Melbourne	Victoria
Australia	Nucleus Network- Centre for Clinical Studies	Melbourne	Victoria
Australia	St. Vincent's Hospital	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Anavex Life Sciences Corp.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Safety	Up to 208 weeks
Secondary	Score from MMSE (Mini-mental state examination score)	Exploratory Efficacy	Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, 169, 182, 195, 208
Secondary	Score from ADCS-ADL (Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory)	Exploratory Efficacy	Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, 169, 182, 195, 208
Secondary	HAM-D Score (Hamilton Psychiatric Rating Scale for Depression)	Exploratory Efficacy	Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, 169, 182, 195, 208