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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004780-75 | EudraCT Number |
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Data obtained from the M11-427 study is not critical to the continued evaluation of ABT-126.
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This is a long term extension study to evaluate safety and tolerability of subjects who complete study M10-985 which is evaluating a new treatment for subjects with mild to moderate Alzheimer's disease.
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 M10-985. Up to 410 subjects may participate at approximately 30 sites in several countries.
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| 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 |
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Inclusion Criteria:
- The subject and caregiver must voluntarily sign and date an informed consent. If the subject does not have the capacity to provide informed consent, full informed consent must be obtained from the subject's representative and assent must be obtained from the subject. - The subject was randomized into Study M10-985 and completed dosing through Week 24 in that study. - With the exception of a diagnosis of mild to moderate AD and the presence of stable medical conditions, the subject is in general good health, based upon the results of medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG. - If male, the subject is surgically sterile (vasectomy, is sexually inactive, or is using a barrier method of birth control (condom) with spermicidal foam/gel/film/cream/suppository for the duration of the study and for 30 days following the last dose of study drug. However, if the male subject's partner has been postmenopausal for at least 2 years or is surgically sterile, then use of a barrier method of birth control is not required. - The subject has an identified, reliable caregiver who will provide support and ensure compliance with the study medication and procedures, and provide accurate information about the subject's status during the study. - The subject and caregiver must have sufficient visual, hearing and graphomotor skills to complete the study procedures.
Exclusion Criteria:
- Experienced an adverse event or abnormal finding in physical examination, vital signs, laboratory profile and/or ECG measurements in Study M10-985 that indicates the subject could become medically unstable during the current study. - The subject is currently taking or is expected to be prescribed any excluded medications (including acetylcholinesterase inhibitors or memantine), without the approval of Abbott medical monitor. - The subject anticipates a move outside the geographic area of the investigative site or is planning extended travel inconsistent with the recommended visit intervals. - The subject is currently enrolled in, or plans to participate in, another experimental study during the course of this trial. - The subject developed any significant medical or psychiatric condition that, in the opinion of the investigator, renders the subject an unsuitable candidate to participate in this study. - For any other reason the investigator considers the subject to be an unsuitable candidate to receive ABT-126 or to participate in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Laura Gault, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 73493 | Delray Beach | Florida | 33445 | United States | ||
| Site Reference ID/Investigator# 73496 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27756421 | Result | Gault LM, Lenz RA, Ritchie CW, Meier A, Othman AA, Tang Q, Berry S, Pritchett Y, Robieson WZ. ABT-126 monotherapy in mild-to-moderate Alzheimer's dementia: randomized double-blind, placebo and active controlled adaptive trial and open-label extension. Alzheimers Res Ther. 2016 Oct 18;8(1):44. doi: 10.1186/s13195-016-0210-1. |
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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 |
| West Palm Beach |
| Florida |
| 33407 |
| United States |
| Site Reference ID/Investigator# 73495 | Elk Grove Village | Illinois | 60007 | United States |
| Site Reference ID/Investigator# 73494 | Staten Island | New York | 10312 | United States |
| Site Reference ID/Investigator# 97035 | Wichita Falls | Texas | 76309 | United States |
| Site Reference ID/Investigator# 73514 | Poznan | 61-853 | Poland |
| Site Reference ID/Investigator# 73515 | Szczecin | 71-215 | Poland |
| Site Reference ID/Investigator# 73516 | Kazan' | 420012 | Russia |
| Site Reference ID/Investigator# 73525 | Kazan' | 420097 | Russia |
| Site Reference ID/Investigator# 73523 | Kirov | 610014 | Russia |
| Site Reference ID/Investigator# 73521 | Moscow | 119048 | Russia |
| Site Reference ID/Investigator# 73519 | Moscow | 123995 | Russia |
| Site Reference ID/Investigator# 73517 | Novosibirsk | 630064 | Russia |
| Site Reference ID/Investigator# 73518 | Saint Petersburg | 190020 | Russia |
| Site Reference ID/Investigator# 73524 | Saint Petersburg | 190103 | Russia |
| Site Reference ID/Investigator# 84615 | Saint Petersburg | 192019 | Russia |
| Site Reference ID/Investigator# 73522 | Saint Petersburg | 198510 | Russia |
| Site Reference ID/Investigator# 73520 | Saratov | 410060 | Russia |
| Site Reference ID/Investigator# 73507 | Belville | 7530 | South Africa |
| Site Reference ID/Investigator# 84614 | Cape Town | 7925 | South Africa |
| Site Reference ID/Investigator# 73505 | George | 6529 | South Africa |
| Site Reference ID/Investigator# 73506 | Johannesburg | 2196 | South Africa |
| Site Reference ID/Investigator# 73533 | Donetsk | 83037 | Ukraine |
| Site Reference ID/Investigator# 73534 | Kiev | 04112 | Ukraine |
| Site Reference ID/Investigator# 73535 | Poltava | 36006 | Ukraine |
| Site Reference ID/Investigator# 73502 | Bath | BA1 3NG | United Kingdom |
| Site Reference ID/Investigator# 73503 | Blackburn | BB2 3HH | United Kingdom |
| Site Reference ID/Investigator# 73501 | Glasgow | G20 0XA | United Kingdom |
| Site Reference ID/Investigator# 73504 | London | TW8 8DS | 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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