Evaluate the 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 to Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors

This is an efficacy and safety study evaluating a new treatment for subjects with mild to moderate Alzheimer's disease.

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: placebo; Drug: ABT-126; Drug: ABT-126

Detailed Description

This is a Phase 2 study designed to evaluate the efficacy and safety of ABT-126 in approximately 420 adults with mild to moderate Alzheimer's disease who are taking stable doses of acetylcholinesterase inhibitors. Subjects will be randomized to one of two ABT-126 dose arms or placebo for a 24-week treatment period.

• Study Type: Interventional
• Enrollment (Actual): 434
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Gatineau, Canada, J9A 1K7
    • Site Reference ID/Investigator# 71793
  • Montreal, Canada, H3T 1E2
    • Site Reference ID/Investigator# 71794
  • Peterborough, Canada, K9H 2P4
    • Site Reference ID/Investigator# 71798
  • Toronto, Canada, M3B 2S7
    • Site Reference ID/Investigator# 71795
  • Verdun, Canada, H4H 1R3
    • Site Reference ID/Investigator# 71796
• France
  • Dijon Cedex, France, 21033
    • Site Reference ID/Investigator# 71573
  • Limoges Cedex, France, 87042
    • Site Reference ID/Investigator# 77833
  • Paris, France, 75013
    • Site Reference ID/Investigator# 68706
  • Paris Cedex 10, France, 75475
    • Site Reference ID/Investigator# 68704
  • Toulouse Cedex 9, France, 31059
    • Site Reference ID/Investigator# 68705
• Germany
  • Berlin, Germany, 14050
    • Site Reference ID/Investigator# 68768
  • Freiburg, Germany, 79106
    • Site Reference ID/Investigator# 68764
  • Huettenberg, Germany, 35625
    • Site Reference ID/Investigator# 68767
  • Mittweida, Germany, 09648
    • Site Reference ID/Investigator# 69960
  • Munich, Germany, 81675
    • Site Reference ID/Investigator# 68765
  • Schwerin, Germany, 19053
    • Site Reference ID/Investigator# 69959
• Greece
  • Athens, Greece, 115 21
    • Site Reference ID/Investigator# 68730
  • Athens, Greece, 151 25
    • Site Reference ID/Investigator# 68732
  • Athens, Greece, 15123
    • Site Reference ID/Investigator# 68733
  • Haidari, Athens, Greece, 12462
    • Site Reference ID/Investigator# 68731
  • Thessaloniki, Greece, 56403
    • Site Reference ID/Investigator# 68729
  • Thessaloniki, Greece, 570 10
    • Site Reference ID/Investigator# 68735
• South Africa
  • Belville, South Africa, 7530
    • Site Reference ID/Investigator# 67586
  • Cape Town, South Africa, 7405
    • Site Reference ID/Investigator# 67582
  • George, South Africa, 6529
    • Site Reference ID/Investigator# 67584
  • Johannesburg, South Africa, 2196
    • Site Reference ID/Investigator# 67585
  • Rosebank, South Africa, 2196
    • Site Reference ID/Investigator# 67583
• United Kingdom
  • Bath, United Kingdom, BA1 3NG
    • Site Reference ID/Investigator# 67787
  • Glasgow, United Kingdom, G20 0XA
    • Site Reference ID/Investigator# 67784
  • London, United Kingdom, TW8 8DS
    • Site Reference ID/Investigator# 67786
  • Manchester, United Kingdom, M8 5RB
    • Site Reference ID/Investigator# 67785
  • Warrington, United Kingdom, WA2 8WA
    • Site Reference ID/Investigator# 67783
• United States
  • California
    • Fresno, California, United States, 93720
      • Site Reference ID/Investigator# 66528
    • Long Beach, California, United States, 90806
      • Site Reference ID/Investigator# 69602
    • San Francisco, California, United States, 94109-4841
      • Site Reference ID/Investigator# 66527
  • Connecticut
    • Hamden, Connecticut, United States, 06518
      • Site Reference ID/Investigator# 66530
  • Florida
    • Delray Beach, Florida, United States, 33445
      • Site Reference ID/Investigator# 66522
    • Orlando, Florida, United States, 32806
      • Site Reference ID/Investigator# 66524
    • Tampa, Florida, United States, 33613
      • Site Reference ID/Investigator# 66531
    • West Palm Beach, Florida, United States, 33407
      • Site Reference ID/Investigator# 66529
  • Illinois
    • Elk Grove Village, Illinois, United States, 60007
      • Site Reference ID/Investigator# 66526
  • New York
    • Staten Island, New York, United States, 10312
      • Site Reference ID/Investigator# 66525
  • Vermont
    • Bennington, Vermont, United States, 05201
      • Site Reference ID/Investigator# 66523

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 is a male or female between the ages of 55 and 90 years, inclusive, at Screening Visit 1. Main Inclusion (Continued):
• The subject meets the Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD.
• The subject must be receiving a stable dose of an AChEI (donepezil or rivastigmine) for at least 90 days prior to Screening Visit 1.
• The subject has a Mini-Mental Status Examination (MMSE) total score of 12 to 24, inclusive, at Screening Visit 1.
• The subject has a Cornell Scale for Depression in Dementia (CSDD) score ≤ 10 at Screening Visit 1.
• The subject has a Modified Hachinski Ischemic Scale (MHIS) score of ≤ 4 at Screening Visit 1.
• With the exception of a diagnosis of mild-to-moderate Alzheimer's disease 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 electrocardiogram (ECG).
• 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.

Exclusion Criteria:

• The subject has taken galantamine or memantine within 60 days prior to Screening Visit 1.
• The subject has received excluded concomitant medications.
• The subject has clinically significant abnormal laboratory values at Screening Visit 1 as determined by the investigator.
• The subject has a history of any significant neurologic disease other than Alzheimer's disease including Parkinson's disease, multi-infarct or vascular dementia, Huntington's disease, normal pressure hydrocephalus, progressive supranuclear palsy, multiple sclerosis, any seizures, mental retardation or a history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities.
• In the opinion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABT-126 Low Dose; low dose	Drug: ABT-126; Low Dose; Drug: ABT-126; High Dose
Experimental: ABT-126 High Dose; high dose	Drug: ABT-126; Low Dose; Drug: ABT-126; High Dose
Placebo Comparator: sugar pill; Placebo	Drug: placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alzheimer's Disease Assessment Scale - cognitive subscale	An assessment tool which focuses on cognitive function and memory	Measurements up through 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)	Caregiver-based assessment of activities of daily living	Measurements up through 24 weeks
DEMentia Quality of Life (DEMQOL)	Health-related quality of life measurement tool	Measurements up through 24 weeks
Clinician Interview-Based Impression of Change - plus (CIBIC-plus)	Measures a global impression of change in severity of dementia	Measurements up through 24 weeks
Neuropsychiatry Inventory (NPI)	Assesses the presence of psychopathology in subjects with Alzheimer's disease and other dementias	Measurements up through 24 weeks
Partner-Patient Questionnaire for Shared Activities (PPQSA)	Measures the extent to which mood and mental state interferes with the patient-partner relationship	Measurements up through 24 weeks
Resource Use in Dementia (RUD-Lite)	Brief measurement tool for resource utilization	Measurements up through 24 weeks
EuroQol-5D Questionnaires	Assesses patient's mobility, self-care, usual activity, pain/discomfort and anxiety/depression	Measurements up through 24 weeks
Mini Mental Status Exam	Questionnaire which provides a quantitative measure of cognition	Measurements up through 24 weeks
Wechsler Memory Scale-III (WMS-III) Working Memory Index	Assesses working memory	Measurements up through 18 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: March 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: March 7, 2012
• First Submitted That Met QC Criteria: March 7, 2012
• First Posted (Estimate): March 9, 2012

Study Record Updates

• Last Update Posted (Estimate): October 31, 2014
• Last Update Submitted That Met QC Criteria: October 24, 2014
• Last Verified: October 1, 2014

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: M11-793; 2011-004849-40 (EudraCT Number)