Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease

A Randomized, Double-Blind, Placebo and Active-Controlled Study to Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease

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: donepezil; Drug: ABT-126

Detailed Description

This is a Phase 2 study designed to evaluate the efficacy and safety of ABT-126 in approximately 410 adults with mild to moderate Alzheimer's disease. Subjects will be randomized to one of 5 treatment groups (ABT-126, donepezil or placebo) for a 24-week treatment period.

• Study Type: Interventional
• Enrollment (Actual): 438
• Phase: Phase 2

Contacts and Locations

Study Locations

• Poland
  • Gdynia, Poland, 81-361
    • Site Reference ID/Investigator# 62565
  • Poznan, Poland, 61-853
    • Site Reference ID/Investigator# 62563
  • Szczecin, Poland, 71-215
    • Site Reference ID/Investigator# 62562
• Russian Federation
  • Kazan, Russian Federation, 420012
    • Site Reference ID/Investigator# 60945
  • Kazan, Russian Federation, 420097
    • Site Reference ID/Investigator# 60955
  • Kirov, Russian Federation, 610014
    • Site Reference ID/Investigator# 60954
  • Moscow, Russian Federation, 119048
    • Site Reference ID/Investigator# 60951
  • Moscow, Russian Federation, 123995
    • Site Reference ID/Investigator# 60959
  • Novosibirsk, Russian Federation, 630064
    • Site Reference ID/Investigator# 60946
  • Saratov, Russian Federation, 410060
    • Site Reference ID/Investigator# 60950
  • St. Petersburg, Russian Federation, 190020
    • Site Reference ID/Investigator# 60947
  • St. Petersburg, Russian Federation, 190103
    • Site Reference ID/Investigator# 60958
  • St. Petersburg, Russian Federation, 192019
    • Site Reference ID/Investigator# 60949
  • St. Petersburg, Russian Federation, 198510
    • Site Reference ID/Investigator# 60952
• South Africa
  • Belville, South Africa, 7530
    • Site Reference ID/Investigator# 60911
  • Cape Town, South Africa, 7925
    • Site Reference ID/Investigator# 76073
  • George, South Africa, 6529
    • Site Reference ID/Investigator# 60912
  • Johannesburg, South Africa, 2196
    • Site Reference ID/Investigator# 60910
• Ukraine
  • Donetsk, Ukraine, 83037
    • Site Reference ID/Investigator# 60909
  • Kiev, Ukraine, 04112
    • Site Reference ID/Investigator# 60906
  • Poltava, Ukraine, 36006
    • Site Reference ID/Investigator# 60905
• United Kingdom
  • Bath, United Kingdom, BA1 3NG
    • Site Reference ID/Investigator# 60960
  • Blackburn, United Kingdom, BB2 3HH
    • Site Reference ID/Investigator# 60963
  • Glasgow, United Kingdom, G20 0XA
    • Site Reference ID/Investigator# 60962
  • London, United Kingdom, TW8 8DS
    • Site Reference ID/Investigator# 60961
• United States
  • Florida
    • Delray Beach, Florida, United States, 33445
      • Site Reference ID/Investigator# 56503
    • Tampa, Florida, United States, 33613
      • Site Reference ID/Investigator# 56518
    • West Palm Beach, Florida, United States, 33407
      • Site Reference ID/Investigator# 56514
  • Illinois
    • Elk Grove Village, Illinois, United States, 60007
      • Site Reference ID/Investigator# 62611
  • New York
    • Staten Island, New York, United States, 10312
      • Site Reference ID/Investigator# 56506
  • Pennsylvania
    • Jenkintown, Pennsylvania, United States, 19046
      • Site Reference ID/Investigator# 82994
  • Texas
    • Wichita Falls, Texas, United States, 76309
      • Site Reference ID/Investigator# 77636
  • Vermont
    • Bennington, Vermont, United States, 05201
      • Site Reference ID/Investigator# 56504

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 53 years to 88 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.
• The subject meets the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's disease.
• The subject has a Mini-Mental Status Examination (MMSE) total score of 10 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 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 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 is currently taking or has taken a medication for the treatment of Alzheimer's disease or dementia within 60 days prior to Screening Visit 1, or is participating in cognitive therapy for the treatment of Alzheimer's disease or dementia.
• 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.
• The subject has a known hypersensitivity or intolerance to donepezil that lead to discontinuation or a known reported history of donepezil treatment failure.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: sugar pill	Drug: placebo; Placebo Comparator
Active Comparator: donepezil	Drug: donepezil; Active Comparator
Experimental: ABT-126 Low Dose; low dose	Drug: ABT-126; low dose, middle dose, high dose
Experimental: ABT-126 Middle Dose; middle dose	Drug: ABT-126; low dose, middle dose, high dose
Experimental: ABT-126 high dose; high dose	Drug: ABT-126; low dose, middle dose, high dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Alzheimer's Disease Assessment Scale - cognitive subscale	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
Mini Mental Status Exam (MMSE)	Questionnaire which provides a quantitative measure of cognition	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
Wechsler Memory Scale-III (WMS-III) Working Memory Index	Assesses working memory	Measurements up through 24 weeks

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Gault LM, Lenz RA, Ritchie CW, Meier A, Othman AA, Tang Q, Berry S, Pritchett Y, Robieson WZ. ABT-126 monotherapy in mild-to-moderate Alzheimer's dementia: randomized double-blind, placebo and active controlled adaptive trial and open-label extension. Alzheimers Res Ther. 2016 Oct 18;8(1):44. doi: 10.1186/s13195-016-0210-1.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: February 3, 2012
• First Submitted That Met QC Criteria: February 3, 2012
• First Posted (Estimate): February 7, 2012

Study Record Updates

• Last Update Posted (Estimate): November 19, 2014
• Last Update Submitted That Met QC Criteria: November 6, 2014
• Last Verified: November 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; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Nootropic Agents; Cholinesterase Inhibitors; Donepezil
• Other Study ID Numbers: M10-985; 2011-002004-32 (EudraCT Number)