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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004849-40 | EudraCT Number |
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This is an efficacy and safety study evaluating a new treatment for subjects with mild to moderate Alzheimer's disease.
This is a Phase 2 study designed to evaluate the efficacy and safety of ABT-126 in approximately 420 adults with mild to moderate Alzheimer's disease who are taking stable doses of acetylcholinesterase inhibitors. Subjects will be randomized to one of two ABT-126 dose arms or placebo for a 24-week treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT-126 Low Dose | Experimental | low dose |
|
| ABT-126 High Dose | Experimental | high dose |
|
| sugar pill | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-126 | Drug | Low Dose |
| |
| ABT-126 |
| Measure | Description | Time Frame |
|---|---|---|
| Alzheimer's Disease Assessment Scale - cognitive subscale | An assessment tool which focuses on cognitive function and memory | Measurements up through 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mini Mental Status Exam | Questionnaire which provides a quantitative measure of cognition | Measurements up through 24 weeks |
| Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Gault, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 66528 | Fresno | California | 93720 | United States | ||
| Site Reference ID/Investigator# 69602 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26967214 | Derived | Florian H, Meier A, Gauthier S, Lipschitz S, Lin Y, Tang Q, Othman AA, Robieson WZ, Gault LM. Efficacy and Safety of ABT-126 in Subjects with Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors: A Randomized, Double-Blind, Placebo-Controlled Study. J Alzheimers Dis. 2016;51(4):1237-47. doi: 10.3233/JAD-150978. |
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| Drug |
High Dose |
|
| placebo | Drug | Placebo |
|
Caregiver-based assessment of activities of daily living
| Measurements up through 24 weeks |
| DEMentia Quality of Life (DEMQOL) | Health-related quality of life measurement tool | Measurements up through 24 weeks |
| Clinician Interview-Based Impression of Change - plus (CIBIC-plus) | Measures a global impression of change in severity of dementia | Measurements up through 24 weeks |
| Neuropsychiatry Inventory (NPI) | Assesses the presence of psychopathology in subjects with Alzheimer's disease and other dementias | Measurements up through 24 weeks |
| Partner-Patient Questionnaire for Shared Activities (PPQSA) | Measures the extent to which mood and mental state interferes with the patient-partner relationship | Measurements up through 24 weeks |
| Resource Use in Dementia (RUD-Lite) | Brief measurement tool for resource utilization | Measurements up through 24 weeks |
| EuroQol-5D Questionnaires | Assesses patient's mobility, self-care, usual activity, pain/discomfort and anxiety/depression | Measurements up through 24 weeks |
| Wechsler Memory Scale-III (WMS-III) Working Memory Index | Assesses working memory | Measurements up through 18 weeks |
| Long Beach |
| California |
| 90806 |
| United States |
| Site Reference ID/Investigator# 66527 | San Francisco | California | 94109-4841 | United States |
| Site Reference ID/Investigator# 66530 | Hamden | Connecticut | 06518 | United States |
| Site Reference ID/Investigator# 66522 | Delray Beach | Florida | 33445 | United States |
| Site Reference ID/Investigator# 66524 | Orlando | Florida | 32806 | United States |
| Site Reference ID/Investigator# 66531 | Tampa | Florida | 33613 | United States |
| Site Reference ID/Investigator# 66529 | West Palm Beach | Florida | 33407 | United States |
| Site Reference ID/Investigator# 66526 | Elk Grove Village | Illinois | 60007 | United States |
| Site Reference ID/Investigator# 66525 | Staten Island | New York | 10312 | United States |
| Site Reference ID/Investigator# 66523 | Bennington | Vermont | 05201 | United States |
| Site Reference ID/Investigator# 71793 | Gatineau | J9A 1K7 | Canada |
| Site Reference ID/Investigator# 71794 | Montreal | H3T 1E2 | Canada |
| Site Reference ID/Investigator# 71798 | Peterborough | K9H 2P4 | Canada |
| Site Reference ID/Investigator# 71795 | Toronto | M3B 2S7 | Canada |
| Site Reference ID/Investigator# 71796 | Verdun | H4H 1R3 | Canada |
| Site Reference ID/Investigator# 71573 | Dijon | 21033 | France |
| Site Reference ID/Investigator# 77833 | Limoges | 87042 | France |
| Site Reference ID/Investigator# 68706 | Paris | 75013 | France |
| Site Reference ID/Investigator# 68704 | Paris | 75475 | France |
| Site Reference ID/Investigator# 68705 | Toulouse | 31059 | France |
| Site Reference ID/Investigator# 68768 | Berlin | 14050 | Germany |
| Site Reference ID/Investigator# 68764 | Freiburg im Breisgau | 79106 | Germany |
| Site Reference ID/Investigator# 68767 | Hüttenberg | 35625 | Germany |
| Site Reference ID/Investigator# 69960 | Mittweida | 09648 | Germany |
| Site Reference ID/Investigator# 68765 | Munich | 81675 | Germany |
| Site Reference ID/Investigator# 69959 | Schwerin | 19053 | Germany |
| Site Reference ID/Investigator# 68730 | Athens | 115 21 | Greece |
| Site Reference ID/Investigator# 68732 | Athens | 151 25 | Greece |
| Site Reference ID/Investigator# 68733 | Athens | 15123 | Greece |
| Site Reference ID/Investigator# 68731 | Haidari, Athens | 12462 | Greece |
| Site Reference ID/Investigator# 68729 | Thessaloniki | 56403 | Greece |
| Site Reference ID/Investigator# 68735 | Thessaloniki | 570 10 | Greece |
| Site Reference ID/Investigator# 67586 | Belville | 7530 | South Africa |
| Site Reference ID/Investigator# 67582 | Cape Town | 7405 | South Africa |
| Site Reference ID/Investigator# 67584 | George | 6529 | South Africa |
| Site Reference ID/Investigator# 67585 | Johannesburg | 2196 | South Africa |
| Site Reference ID/Investigator# 67583 | Rosebank | 2196 | South Africa |
| Site Reference ID/Investigator# 67787 | Bath | BA1 3NG | United Kingdom |
| Site Reference ID/Investigator# 67784 | Glasgow | G20 0XA | United Kingdom |
| Site Reference ID/Investigator# 67786 | London | TW8 8DS | United Kingdom |
| Site Reference ID/Investigator# 67785 | Manchester | M8 5RB | United Kingdom |
| Site Reference ID/Investigator# 67783 | Warrington | WA2 8WA | United Kingdom |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000618299 | ABT-126 |
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