Safety and Tolerability Study Evaluating a New Treatment for Subjects With Mild to Moderate Alzheimer's Disease
- Registration Number
- NCT01690195
- Lead Sponsor
- AbbVie (prior sponsor, Abbott)
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 343
- 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 M11-793 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 two 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.
- The subject experienced an adverse event or abnormal finding in physical examination, vital signs, laboratory profile and/or ECG measurements in Study M11-793 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 without the approval of Abbott medical monitor.
- The subject was noncompliant with donepezil or rivastigmine during Study M11-793 or is expected to discontinue these medications prior to conclusion of this study.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ABT-126 ABT-126 ABT-126 Open-label dose
- Primary Outcome Measures
Name Time Method Electrocardiogram Assessments up through 28 weeks Measurements include heart rate, RR interval, PR interval, QRS duration and QT intervals
Vital Signs Assessments up through 28 weeks Assessments include pulse, blood pressure and oral body temperature
Adverse Events 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 Assessments up through 28 weeks Assessments include hematology, clinical chemistry, urinalysis and urine drug/alcohol screens
Physical examinations Assessments up through 28 weeks An examination of bodily functions and physical condition
Brief Neurological examination Assessments up through 28 weeks Assessments include cranial nerves, motor and sensory system, reflexes, coordination, gait and station
Brief Psychiatric assessments Assessments up through 28 weeks Assessments include mood, anxiety, psychosis or delusions, agitation, homicidal thoughts or behaviors
Columbia-Suicide Severity Rating Scale Assessments up through 28 weeks The scale is designed to assess suicidal behavior and ideation
Cornell Scale for Depression in Dementia Assessments up through 28 weeks Assesses the signs and symptoms of major depression in patients with dementia
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (39)
Site Reference ID/Investigator# 84187
🇺🇸Hamden, Connecticut, United States
Site Reference ID/Investigator# 84173
🇨🇦Gatineau, Canada
Site Reference ID/Investigator# 84391
🇿🇦Cape Town, South Africa
Site Reference ID/Investigator# 84398
🇬🇧Bath, United Kingdom
Site Reference ID/Investigator# 84185
🇺🇸Long Beach, California, United States
Site Reference ID/Investigator# 84176
🇨🇦Verdun, Canada
Site Reference ID/Investigator# 84374
🇫🇷Paris Cedex 10, France
Site Reference ID/Investigator# 84400
🇬🇧London, United Kingdom
Site Reference ID/Investigator# 84388
🇬🇷Athens, Greece
Site Reference ID/Investigator# 84390
🇬🇷Thessaloniki, Greece
Site Reference ID/Investigator# 84394
🇿🇦Johannesburg, South Africa
Site Reference ID/Investigator# 84392
🇿🇦Rosebank, South Africa
Site Reference ID/Investigator# 84386
🇬🇷Haidari, Athens, Greece
Site Reference ID/Investigator# 84395
🇿🇦Belville, South Africa
Site Reference ID/Investigator# 84393
🇿🇦George, South Africa
Site Reference ID/Investigator# 84183
🇺🇸San Francisco, California, United States
Site Reference ID/Investigator# 84178
🇺🇸Delray Beach, Florida, United States
Site Reference ID/Investigator# 84186
🇺🇸West Palm Beach, Florida, United States
Site Reference ID/Investigator# 84181
🇺🇸Staten Island, New York, United States
Site Reference ID/Investigator# 84383
🇩🇪Huettenberg, Germany
Site Reference ID/Investigator# 84381
🇩🇪Munich, Germany
Site Reference ID/Investigator# 84180
🇺🇸Orlando, Florida, United States
Site Reference ID/Investigator# 84182
🇺🇸Elk Grove Village, Illinois, United States
Site Reference ID/Investigator# 84174
🇨🇦Montreal, Canada
Site Reference ID/Investigator# 84175
🇨🇦Toronto, Canada
Site Reference ID/Investigator# 84177
🇨🇦Peterborough, Canada
Site Reference ID/Investigator# 84376
🇫🇷Dijon Cedex, France
Site Reference ID/Investigator# 84373
🇫🇷Limoges Cedex, France
Site Reference ID/Investigator# 84377
🇫🇷Paris, France
Site Reference ID/Investigator# 84375
🇫🇷Toulouse Cedex 9, France
Site Reference ID/Investigator# 84380
🇩🇪Freiburg, Germany
Site Reference ID/Investigator# 84382
🇩🇪Berlin, Germany
Site Reference ID/Investigator# 84385
🇬🇷Athens, Greece
Site Reference ID/Investigator# 84379
🇩🇪Mittweida, Germany
Site Reference ID/Investigator# 84378
🇩🇪Schwerin, Germany
Site Reference ID/Investigator# 84389
🇬🇷Athens, Greece
Site Reference ID/Investigator# 84397
🇬🇧Glasgow, United Kingdom
Site Reference ID/Investigator# 84399
🇬🇧Manchester, United Kingdom
Site Reference ID/Investigator# 84179
🇺🇸Bennington, Vermont, United States