This is a Safety and Tolerability Study Evaluating a New Treatment for Subjects With Mild to Moderate Alzheimer's Disease
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01676935 |
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Recruitment Status :
Terminated
(Data obtained from the M11-427 study is not critical to the continued evaluation of ABT-126.)
First Posted : August 31, 2012
Last Update Posted : August 2, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alzheimer's Disease | Drug: ABT-126 | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 349 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Long-Term Safety and Tolerability of ABT-126 in Subjects With Mild-to-Moderate Alzheimer's Disease: An Open-Label Extension Study for Subjects Completing Study M10-985 |
| Study Start Date : | August 2012 |
| Actual Primary Completion Date : | March 2014 |
| Actual Study Completion Date : | March 2014 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: ABT-126
ABT-126 Open-label dose
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Drug: ABT-126
See arm description |
- Adverse Events [ Time Frame: Assessments up through 28 weeks ]Monitor each subject for clinical and laboratory evidence of adverse events on a routine basis throughout the study
- Laboratory Data [ Time Frame: Assessments up through 28 weeks ]Assessments include hematology, clinical chemistry, urinalysis and urine drug/alcohol screens.
- Vital Signs [ Time Frame: Assessments up through 28 weeks ]Assessments include pulse, blood pressure and oral body temperature
- Physical examinations [ Time Frame: Assessments up through 28 weeks ]An examination of bodily functions and physical condition
- Brief Neurological examination [ Time Frame: Assessments up through 28 weeks ]Assessments include cranial nerves, motor and sensory system, reflexes, coordination, gait and station
- Brief Psychiatric assessments [ Time Frame: Assessments up through 28 weeks ]Assessments include mood, anxiety, psychosis or delusions, agitation, homicidal thoughts or behaviors.
- Columbia-Suicide Severity Rating Scale [ Time Frame: Assessments up through 28 weeks ]The scale is designed to assess suicidal behavior and ideation
- Cornell Scale for Depression in Dementia [ Time Frame: Assessments up through 28 weeks ]Assesses the signs and symptoms of major depression in patients with dementia.
- Electrocardiogram [ Time Frame: Assessments up through 28 weeks ]Measurements include heart rate, RR interval, PR interval, QRS duration and QT intervals
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 55 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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): NCT01676935
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| Study Director: | Laura Gault, MD | AbbVie |
| Responsible Party: | AbbVie (prior sponsor, Abbott) |
| ClinicalTrials.gov Identifier: | NCT01676935 |
| Other Study ID Numbers: |
M11-427 2011-004780-75 ( EudraCT Number ) |
| First Posted: | August 31, 2012 Key Record Dates |
| Last Update Posted: | August 2, 2021 |
| Last Verified: | July 2021 |
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Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |