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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ANAVEX2-73 Oral as assigned in ANAVEX2-73-002 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANAVEX2-73 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Safety | Up to 208 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Score from ADCS-ADL (Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Melbourne Health - The Royal Melbourne Hospital | Melbourne | Victoria | 3050 | Australia | ||
| Austin Health - Heidelberg Repatriation Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32318621 | Derived | Hampel H, Williams C, Etcheto A, Goodsaid F, Parmentier F, Sallantin J, Kaufmann WE, Missling CU, Afshar M. A precision medicine framework using artificial intelligence for the identification and confirmation of genomic biomarkers of response to an Alzheimer's disease therapy: Analysis of the blarcamesine (ANAVEX2-73) Phase 2a clinical study. Alzheimers Dement (N Y). 2020 Apr 19;6(1):e12013. doi: 10.1002/trc2.12013. eCollection 2020. |
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Study results will be presented at a scientific conference and/or published.
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C568535 | tetrahydro-N, N-dimethyl-2,2-diphenyl-3-furanmethanamine hydrochloride |
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Exploratory Efficacy |
| Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, 169, 182, 195, 208 |
| 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 |
| Melbourne |
| Victoria |
| 3084 |
| Australia |
| Caulfield Hospital | Melbourne | Victoria | 3162 | Australia |
| Nucleus Network- Centre for Clinical Studies | Melbourne | Victoria | Australia |
| St. Vincent's Hospital | Melbourne | Victoria | Australia |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |