An Extension Study of ANAVEX2-73 in Patients With Mild to Moderate Alzheimer's Disease
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ClinicalTrials.gov Identifier: NCT02756858 |
Recruitment Status :
Completed
First Posted : April 29, 2016
Last Update Posted : January 12, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer's Disease | Drug: ANAVEX2-73 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 21 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Extension Study of ANAVEX2-73 in Patients With Mild to Moderate Alzheimer's Disease |
Study Start Date : | March 2016 |
Actual Primary Completion Date : | November 2020 |
Actual Study Completion Date : | November 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: ANAVEX2-73 Oral as assigned in ANAVEX2-73-002 |
Drug: ANAVEX2-73 |
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Up to 208 weeks ]Safety
- Score from MMSE (Mini-mental state examination score) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, 169, 182, 195, 208 ]Exploratory Efficacy

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Ages Eligible for Study: | 55 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02756858
Australia, Victoria | |
Melbourne Health - The Royal Melbourne Hospital | |
Melbourne, Victoria, Australia, 3050 | |
Austin Health - Heidelberg Repatriation Hospital | |
Melbourne, Victoria, Australia, 3084 | |
Caulfield Hospital | |
Melbourne, Victoria, Australia, 3162 | |
Nucleus Network- Centre for Clinical Studies | |
Melbourne, Victoria, Australia | |
St. Vincent's Hospital | |
Melbourne, Victoria, Australia |
Responsible Party: | Anavex Life Sciences Corp. |
ClinicalTrials.gov Identifier: | NCT02756858 |
Other Study ID Numbers: |
ANAVEX2-73-003 |
First Posted: | April 29, 2016 Key Record Dates |
Last Update Posted: | January 12, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Study results will be presented at a scientific conference and/or published. |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |