- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01676935
This is a Safety and Tolerability Study Evaluating a New Treatment for Subjects With Mild to Moderate Alzheimer's Disease
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 Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Poznan, Poland, 61-853
- Site Reference ID/Investigator# 73514
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Szczecin, Poland, 71-215
- Site Reference ID/Investigator# 73515
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Kazan, Russian Federation, 420012
- Site Reference ID/Investigator# 73516
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Kazan, Russian Federation, 420097
- Site Reference ID/Investigator# 73525
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Kirov, Russian Federation, 610014
- Site Reference ID/Investigator# 73523
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Moscow, Russian Federation, 119048
- Site Reference ID/Investigator# 73521
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Moscow, Russian Federation, 123995
- Site Reference ID/Investigator# 73519
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Novosibirsk, Russian Federation, 630064
- Site Reference ID/Investigator# 73517
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Saratov, Russian Federation, 410060
- Site Reference ID/Investigator# 73520
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St. Petersburg, Russian Federation, 190020
- Site Reference ID/Investigator# 73518
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St. Petersburg, Russian Federation, 190103
- Site Reference ID/Investigator# 73524
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St. Petersburg, Russian Federation, 192019
- Site Reference ID/Investigator# 84615
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St. Petersburg, Russian Federation, 198510
- Site Reference ID/Investigator# 73522
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Belville, South Africa, 7530
- Site Reference ID/Investigator# 73507
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Cape Town, South Africa, 7925
- Site Reference ID/Investigator# 84614
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George, South Africa, 6529
- Site Reference ID/Investigator# 73505
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Johannesburg, South Africa, 2196
- Site Reference ID/Investigator# 73506
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Donetsk, Ukraine, 83037
- Site Reference ID/Investigator# 73533
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Kiev, Ukraine, 04112
- Site Reference ID/Investigator# 73534
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Poltava, Ukraine, 36006
- Site Reference ID/Investigator# 73535
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Bath, United Kingdom, BA1 3NG
- Site Reference ID/Investigator# 73502
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Blackburn, United Kingdom, BB2 3HH
- Site Reference ID/Investigator# 73503
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Glasgow, United Kingdom, G20 0XA
- Site Reference ID/Investigator# 73501
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London, United Kingdom, TW8 8DS
- Site Reference ID/Investigator# 73504
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Florida
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Delray Beach, Florida, United States, 33445
- Site Reference ID/Investigator# 73493
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West Palm Beach, Florida, United States, 33407
- Site Reference ID/Investigator# 73496
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Illinois
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Elk Grove Village, Illinois, United States, 60007
- Site Reference ID/Investigator# 73495
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New York
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Staten Island, New York, United States, 10312
- Site Reference ID/Investigator# 73494
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Texas
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Wichita Falls, Texas, United States, 76309
- Site Reference ID/Investigator# 97035
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: ABT-126
ABT-126 Open-label dose
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See arm description
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Adverse Events
Time Frame: Assessments up through 28 weeks
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Monitor each subject for clinical and laboratory evidence of adverse events on a routine basis throughout the study
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Assessments up through 28 weeks
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Vital Signs
Time Frame: Assessments up through 28 weeks
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Assessments include pulse, blood pressure and oral body temperature
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Assessments up through 28 weeks
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Physical examinations
Time Frame: Assessments up through 28 weeks
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An examination of bodily functions and physical condition
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Assessments up through 28 weeks
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Brief Neurological examination
Time Frame: Assessments up through 28 weeks
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Assessments include cranial nerves, motor and sensory system, reflexes, coordination, gait and station
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Assessments up through 28 weeks
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Columbia-Suicide Severity Rating Scale
Time Frame: Assessments up through 28 weeks
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The scale is designed to assess suicidal behavior and ideation
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Assessments up through 28 weeks
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Electrocardiogram
Time Frame: Assessments up through 28 weeks
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Measurements include heart rate, RR interval, PR interval, QRS duration and QT intervals
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Assessments up through 28 weeks
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Laboratory Data
Time Frame: Assessments up through 28 weeks
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Assessments include hematology, clinical chemistry, urinalysis and urine drug/alcohol screens.
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Assessments up through 28 weeks
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Brief Psychiatric assessments
Time Frame: Assessments up through 28 weeks
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Assessments include mood, anxiety, psychosis or delusions, agitation, homicidal thoughts or behaviors.
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Assessments up through 28 weeks
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Cornell Scale for Depression in Dementia
Time Frame: Assessments up through 28 weeks
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Assesses the signs and symptoms of major depression in patients with dementia.
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Assessments up through 28 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Laura Gault, MD, AbbVie
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M11-427
- 2011-004780-75 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alzheimer's Disease
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University of Southern CaliforniaAlzheimer's Therapeutic Research Institute; American Heart Association; Schaeffer...RecruitingDementia | Alzheimer Disease | Prodromal Alzheimer's Disease | Preclinical Alzheimer's DiseaseUnited States
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University of Southern CaliforniaNational Institute on Aging (NIA); Alzheimer's Therapeutic Research Institute; Brigham and Women's Hospital and other collaboratorsActive, not recruitingDementia | Alzheimer Disease | Prodromal Alzheimer's Disease | Preclinical Alzheimer's DiseaseUnited States
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Novoic LimitedRecruitingAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited States
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Novoic LimitedRecruitingAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited Kingdom
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Novoic LimitedCompletedAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited States
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Novoic LimitedCompletedAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited Kingdom
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Novoic LimitedRecruitingAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited Kingdom
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Novoic LimitedRecruitingAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's Disease | Normal CognitionUnited States
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University Hospital, BordeauxMinistry for Health and Solidarity, FranceCompletedAlzheimer's Disease (AD) | Alzheimer's Disease (AD) Related DisordersFrance
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University of Colorado, DenverNational Institute on Aging (NIA)Active, not recruitingSuspected Typical Alzheimer's Disease (AD) | Suspected Atypical Alzheimer's Disease (AD)United States
Clinical Trials on ABT-126
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AbbottCompleted
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AbbottCompleted
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AbbVieTerminatedSchizophreniaUnited States, Russian Federation, United Kingdom
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AbbVie (prior sponsor, Abbott)CompletedSchizophreniaUnited States
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AbbVie (prior sponsor, Abbott)CompletedCognitive Deficits in SchizophreniaUnited States
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AbbVie (prior sponsor, Abbott)CompletedSchizophreniaUnited States, Russian Federation, United Kingdom
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AbbottCompleted
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AbbottCompletedHealthyUnited States
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AbbVie (prior sponsor, Abbott)TerminatedAlzheimer's DiseaseUnited States, Canada, France, Germany, Greece, South Africa, United Kingdom
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AbbottCompletedAlzheimer's DiseaseUnited States