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 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

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.

Study Overview

• Status: Terminated
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: ABT-126

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.

• Study Type: Interventional
• Enrollment (Actual): 343
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Gatineau, Canada, J9A 1K7
    • Site Reference ID/Investigator# 84173
  • Montreal, Canada, H3T 1E2
    • Site Reference ID/Investigator# 84174
  • Peterborough, Canada, K9H 2P4
    • Site Reference ID/Investigator# 84177
  • Toronto, Canada, M3B 2S7
    • Site Reference ID/Investigator# 84175
  • Verdun, Canada, H4H 1R3
    • Site Reference ID/Investigator# 84176
• France
  • Dijon Cedex, France, 21033
    • Site Reference ID/Investigator# 84376
  • Limoges Cedex, France, 87042
    • Site Reference ID/Investigator# 84373
  • Paris, France, 75013
    • Site Reference ID/Investigator# 84377
  • Paris Cedex 10, France, 75475
    • Site Reference ID/Investigator# 84374
  • Toulouse Cedex 9, France, 31059
    • Site Reference ID/Investigator# 84375
• Germany
  • Berlin, Germany, 14050
    • Site Reference ID/Investigator# 84382
  • Freiburg, Germany, 79106
    • Site Reference ID/Investigator# 84380
  • Huettenberg, Germany, 35625
    • Site Reference ID/Investigator# 84383
  • Mittweida, Germany, 09648
    • Site Reference ID/Investigator# 84379
  • Munich, Germany, 81675
    • Site Reference ID/Investigator# 84381
  • Schwerin, Germany, 19053
    • Site Reference ID/Investigator# 84378
• Greece
  • Athens, Greece, 115 21
    • Site Reference ID/Investigator# 84385
  • Athens, Greece, 151 25
    • Site Reference ID/Investigator# 84388
  • Athens, Greece, 15123
    • Site Reference ID/Investigator# 84389
  • Haidari, Athens, Greece, 12462
    • Site Reference ID/Investigator# 84386
  • Thessaloniki, Greece, 570 10
    • Site Reference ID/Investigator# 84390
• South Africa
  • Belville, South Africa, 7530
    • Site Reference ID/Investigator# 84395
  • Cape Town, South Africa, 7405
    • Site Reference ID/Investigator# 84391
  • George, South Africa, 6529
    • Site Reference ID/Investigator# 84393
  • Johannesburg, South Africa, 2196
    • Site Reference ID/Investigator# 84394
  • Rosebank, South Africa, 2196
    • Site Reference ID/Investigator# 84392
• United Kingdom
  • Bath, United Kingdom, BA1 3NG
    • Site Reference ID/Investigator# 84398
  • Glasgow, United Kingdom, G20 0XA
    • Site Reference ID/Investigator# 84397
  • London, United Kingdom, TW8 8DS
    • Site Reference ID/Investigator# 84400
  • Manchester, United Kingdom, M8 5RB
    • Site Reference ID/Investigator# 84399
• United States
  • California
    • Long Beach, California, United States, 90806
      • Site Reference ID/Investigator# 84185
    • San Francisco, California, United States, 94109-4841
      • Site Reference ID/Investigator# 84183
  • Connecticut
    • Hamden, Connecticut, United States, 06518
      • Site Reference ID/Investigator# 84187
  • Florida
    • Delray Beach, Florida, United States, 33445
      • Site Reference ID/Investigator# 84178
    • Orlando, Florida, United States, 32806
      • Site Reference ID/Investigator# 84180
    • West Palm Beach, Florida, United States, 33407
      • Site Reference ID/Investigator# 84186
  • Illinois
    • Elk Grove Village, Illinois, United States, 60007
      • Site Reference ID/Investigator# 84182
  • New York
    • Staten Island, New York, United States, 10312
      • Site Reference ID/Investigator# 84181
  • Vermont
    • Bennington, Vermont, United States, 05201
      • Site Reference ID/Investigator# 84179

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABT-126; ABT-126 Open-label dose	Drug: ABT-126; See arm description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Monitor each subject for clinical and laboratory evidence of adverse events on a routine basis throughout the study	Assessments up through 28 weeks
Laboratory Data	Assessments include hematology, clinical chemistry, urinalysis and urine drug/alcohol screens	Assessments up through 28 weeks
Vital Signs	Assessments include pulse, blood pressure and oral body temperature	Assessments up through 28 weeks
Physical examinations	An examination of bodily functions and physical condition	Assessments up through 28 weeks
Brief Neurological examination	Assessments include cranial nerves, motor and sensory system, reflexes, coordination, gait and station	Assessments up through 28 weeks
Brief Psychiatric assessments	Assessments include mood, anxiety, psychosis or delusions, agitation, homicidal thoughts or behaviors	Assessments up through 28 weeks
Columbia-Suicide Severity Rating Scale	The scale is designed to assess suicidal behavior and ideation	Assessments up through 28 weeks
Cornell Scale for Depression in Dementia	Assesses the signs and symptoms of major depression in patients with dementia	Assessments up through 28 weeks
Electrocardiogram	Measurements include heart rate, RR interval, PR interval, QRS duration and QT intervals	Assessments up through 28 weeks

Collaborators and Investigators

• Sponsor: AbbVie (prior sponsor, Abbott)
• Investigators: Study Director: Laura Gault, MD, AbbVie

Publications and helpful links

General Publications

• Florian H, Meier A, Gauthier S, Lipschitz S, Lin Y, Tang Q, Othman AA, Robieson WZ, Gault LM. Efficacy and Safety of ABT-126 in Subjects with Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors: A Randomized, Double-Blind, Placebo-Controlled Study. J Alzheimers Dis. 2016;51(4):1237-47. doi: 10.3233/JAD-150978.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: September 19, 2012
• First Submitted That Met QC Criteria: September 19, 2012
• First Posted (Estimate): September 21, 2012

Study Record Updates

• Last Update Posted (Actual): August 2, 2021
• Last Update Submitted That Met QC Criteria: July 29, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: M11-428; 2012-000537-39 (EudraCT Number)