Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000537-39 | EudraCT Number |
Not provided
Not provided
Not provided
Data obtained from the M11-428 study is not critical to the continued evaluation of ABT-126.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a long term extension study to evaluate safety and tolerability of subjects who complete study M11-793 which is evaluating a new treatment for subjects with mild to moderate Alzheimer's disease on stable doses of acetylcholinesterase inhibitors.
This is a Phase 2, open-label, multicenter, 28 week extension study to evaluate the long-term safety and tolerability of ABT-126 in subjects who complete dosing through Week 24 of Study M11-793. Up to 420 subjects may participate at approximately 40 sites in seven countries.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT-126 | Experimental | ABT-126 Open-label dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-126 | Drug | See arm description |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Monitor each subject for clinical and laboratory evidence of adverse events on a routine basis throughout the study | Assessments up through 28 weeks |
| Laboratory Data | Assessments include hematology, clinical chemistry, urinalysis and urine drug/alcohol screens | Assessments up through 28 weeks |
| Vital Signs | Assessments include pulse, blood pressure and oral body temperature | Assessments up through 28 weeks |
| Physical examinations | An examination of bodily functions and physical condition | Assessments up through 28 weeks |
| Brief Neurological examination | Assessments include cranial nerves, motor and sensory system, reflexes, coordination, gait and station | Assessments up through 28 weeks |
| Brief Psychiatric assessments | Assessments include mood, anxiety, psychosis or delusions, agitation, homicidal thoughts or behaviors | Assessments up through 28 weeks |
| Columbia-Suicide Severity Rating Scale | The scale is designed to assess suicidal behavior and ideation | Assessments up through 28 weeks |
| Cornell Scale for Depression in Dementia |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Laura Gault, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 84185 | Long Beach | California | 90806 | United States | ||
| Site Reference ID/Investigator# 84183 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26967214 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Assesses the signs and symptoms of major depression in patients with dementia |
| Assessments up through 28 weeks |
| Electrocardiogram | Measurements include heart rate, RR interval, PR interval, QRS duration and QT intervals | Assessments up through 28 weeks |
| San Francisco |
| California |
| 94109-4841 |
| United States |
| Site Reference ID/Investigator# 84187 | Hamden | Connecticut | 06518 | United States |
| Site Reference ID/Investigator# 84178 | Delray Beach | Florida | 33445 | United States |
| Site Reference ID/Investigator# 84180 | Orlando | Florida | 32806 | United States |
| Site Reference ID/Investigator# 84186 | West Palm Beach | Florida | 33407 | United States |
| Site Reference ID/Investigator# 84182 | Elk Grove Village | Illinois | 60007 | United States |
| Site Reference ID/Investigator# 84181 | Staten Island | New York | 10312 | United States |
| Site Reference ID/Investigator# 84179 | Bennington | Vermont | 05201 | United States |
| Site Reference ID/Investigator# 84173 | Gatineau | J9A 1K7 | Canada |
| Site Reference ID/Investigator# 84174 | Montreal | H3T 1E2 | Canada |
| Site Reference ID/Investigator# 84177 | Peterborough | K9H 2P4 | Canada |
| Site Reference ID/Investigator# 84175 | Toronto | M3B 2S7 | Canada |
| Site Reference ID/Investigator# 84176 | Verdun | H4H 1R3 | Canada |
| Site Reference ID/Investigator# 84376 | Dijon | 21033 | France |
| Site Reference ID/Investigator# 84373 | Limoges | 87042 | France |
| Site Reference ID/Investigator# 84377 | Paris | 75013 | France |
| Site Reference ID/Investigator# 84374 | Paris | 75475 | France |
| Site Reference ID/Investigator# 84375 | Toulouse | 31059 | France |
| Site Reference ID/Investigator# 84382 | Berlin | 14050 | Germany |
| Site Reference ID/Investigator# 84380 | Freiburg im Breisgau | 79106 | Germany |
| Site Reference ID/Investigator# 84383 | Hüttenberg | 35625 | Germany |
| Site Reference ID/Investigator# 84379 | Mittweida | 09648 | Germany |
| Site Reference ID/Investigator# 84381 | Munich | 81675 | Germany |
| Site Reference ID/Investigator# 84378 | Schwerin | 19053 | Germany |
| Site Reference ID/Investigator# 84385 | Athens | 115 21 | Greece |
| Site Reference ID/Investigator# 84388 | Athens | 151 25 | Greece |
| Site Reference ID/Investigator# 84389 | Athens | 15123 | Greece |
| Site Reference ID/Investigator# 84386 | Haidari, Athens | 12462 | Greece |
| Site Reference ID/Investigator# 84390 | Thessaloniki | 570 10 | Greece |
| Site Reference ID/Investigator# 84395 | Belville | 7530 | South Africa |
| Site Reference ID/Investigator# 84391 | Cape Town | 7405 | South Africa |
| Site Reference ID/Investigator# 84393 | George | 6529 | South Africa |
| Site Reference ID/Investigator# 84394 | Johannesburg | 2196 | South Africa |
| Site Reference ID/Investigator# 84392 | Rosebank | 2196 | South Africa |
| Site Reference ID/Investigator# 84398 | Bath | BA1 3NG | United Kingdom |
| Site Reference ID/Investigator# 84397 | Glasgow | G20 0XA | United Kingdom |
| Site Reference ID/Investigator# 84400 | London | TW8 8DS | United Kingdom |
| Site Reference ID/Investigator# 84399 | Manchester | M8 5RB | 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000618299 | ABT-126 |
Not provided
Not provided
Not provided