Safety and Tolerability Study Evaluating a New Treatment for Subjects With Mild to Moderate Alzheimer's Disease - Full Text View

Purpose

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.

Condition	Intervention	Phase
Alzheimer's Disease	Drug: ABT-126	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Long-Term Safety and Tolerability of ABT-126 in Adults With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors: An Open-Label Extension Study for Subjects Completing Study M11-793

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia

U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:

Adverse Events [ Time Frame: Assessments up through 28 weeks ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Assessments include hematology, clinical chemistry, urinalysis and urine drug/alcohol screens
Vital Signs [ Time Frame: Assessments up through 28 weeks ] [ Designated as safety issue: Yes ]
Assessments include pulse, blood pressure and oral body temperature
Physical examinations [ Time Frame: Assessments up through 28 weeks ] [ Designated as safety issue: Yes ]
An examination of bodily functions and physical condition
Brief Neurological examination [ Time Frame: Assessments up through 28 weeks ] [ Designated as safety issue: Yes ]
Assessments include cranial nerves, motor and sensory system, reflexes, coordination, gait and station
Brief Psychiatric assessments [ Time Frame: Assessments up through 28 weeks ] [ Designated as safety issue: Yes ]
Assessments include mood, anxiety, psychosis or delusions, agitation, homicidal thoughts or behaviors
Columbia-Suicide Severity Rating Scale [ Time Frame: Assessments up through 28 weeks ] [ Designated as safety issue: Yes ]
The scale is designed to assess suicidal behavior and ideation
Cornell Scale for Depression in Dementia [ Time Frame: Assessments up through 28 weeks ] [ Designated as safety issue: Yes ]
Assesses the signs and symptoms of major depression in patients with dementia
Electrocardiogram [ Time Frame: Assessments up through 28 weeks ] [ Designated as safety issue: Yes ]
Measurements include heart rate, RR interval, PR interval, QRS duration and QT intervals

Estimated Enrollment:	350
Study Start Date:	September 2012
Estimated Study Completion Date:	May 2014
Estimated Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ABT-126 ABT-126 Open-label dose	Drug: ABT-126 See arm description

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.

Eligibility

Ages Eligible for Study:	55 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01690195

Contacts

Contact: Wendy Plyman, BA	847-938-2171	wendy.plyman@abbvie.com
Contact: Betty Prine, BS	847-937-6928	betty.prine@abbvie.com

Show 32 Study Locations

Sponsors and Collaborators

AbbVie (prior sponsor, Abbott)

Investigators

Study Director:

Laura Gault, MD

AbbVie

More Information

No publications provided

Responsible Party:	AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:	NCT01690195 History of Changes
Other Study ID Numbers:	M11-428, 2012-000537-39
Study First Received:	September 19, 2012
Last Updated:	March 6, 2013
Health Authority:	United States: Food and Drug Administration South Africa: Medicines Control Council United Kingdom: Medicines and Healthcare Products Regulatory Agency Canada: Health Canada France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Greece: National Organization of Medicines

Additional relevant MeSH terms:

Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders

Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013