This is a Safety and Tolerability Study Evaluating a New Treatment for Subjects With Mild to Moderate Alzheimer's Disease

This study has been terminated.
(Data obtained from the M11-427 study is not critical to the continued evaluation of ABT-126.)
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01676935
First received: August 29, 2012
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

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.


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 Subjects With Mild-to-Moderate Alzheimer's Disease: An Open-Label Extension Study for Subjects Completing Study M10-985

Resource links provided by NLM:


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


Enrollment: 349
Study Start Date: August 2012
Study Completion Date: March 2014
Primary Completion Date: March 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 M10-985. Up to 410 subjects may participate at approximately 30 sites in several 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 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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01676935

Locations
United States, Florida
Site Reference ID/Investigator# 73493
Delray Beach, Florida, United States, 33445
Site Reference ID/Investigator# 73496
West Palm Beach, Florida, United States, 33407
United States, Illinois
Site Reference ID/Investigator# 73495
Elk Grove Village, Illinois, United States, 60007
United States, New York
Site Reference ID/Investigator# 73494
Staten Island, New York, United States, 10312
United States, Texas
Site Reference ID/Investigator# 97035
Wichita Falls, Texas, United States, 76309
Poland
Site Reference ID/Investigator# 73514
Poznan, Poland, 61-853
Site Reference ID/Investigator# 73515
Szczecin, Poland, 71-215
Russian Federation
Site Reference ID/Investigator# 73516
Kazan, Russian Federation, 420012
Site Reference ID/Investigator# 73525
Kazan, Russian Federation, 420097
Site Reference ID/Investigator# 73523
Kirov, Russian Federation, 610014
Site Reference ID/Investigator# 73519
Moscow, Russian Federation, 123995
Site Reference ID/Investigator# 73521
Moscow, Russian Federation, 119048
Site Reference ID/Investigator# 73517
Novosibirsk, Russian Federation, 630064
Site Reference ID/Investigator# 73520
Saratov, Russian Federation, 410060
Site Reference ID/Investigator# 73522
St. Petersburg, Russian Federation, 198510
Site Reference ID/Investigator# 73524
St. Petersburg, Russian Federation, 190103
Site Reference ID/Investigator# 84615
St. Petersburg, Russian Federation, 192019
Site Reference ID/Investigator# 73518
St. Petersburg, Russian Federation, 190020
South Africa
Site Reference ID/Investigator# 73507
Belville, South Africa, 7530
Site Reference ID/Investigator# 84614
Cape Town, South Africa, 7925
Site Reference ID/Investigator# 73505
George, South Africa, 6529
Site Reference ID/Investigator# 73506
Johannesburg, South Africa, 2196
Ukraine
Site Reference ID/Investigator# 73533
Donetsk, Ukraine, 83037
Site Reference ID/Investigator# 73534
Kiev, Ukraine, 04112
Site Reference ID/Investigator# 73535
Poltava, Ukraine, 36006
United Kingdom
Site Reference ID/Investigator# 73502
Bath, United Kingdom, BA1 3NG
Site Reference ID/Investigator# 73503
Blackburn, United Kingdom, BB2 3HH
Site Reference ID/Investigator# 73501
Glasgow, United Kingdom, G20 0XA
Site Reference ID/Investigator# 73504
London, United Kingdom, TW8 8DS
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: NCT01676935     History of Changes
Other Study ID Numbers: M11-427, 2011-004780-75
Study First Received: August 29, 2012
Last Updated: March 21, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Russia: FSI Scientific Center of Expertise of Medical Application
Ukraine: State Pharmacological Center - Ministry of Health
South Africa: Medicines Control Council
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

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

ClinicalTrials.gov processed this record on September 22, 2014