Clinical trial NCT01549834: Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-03-09
Enrollment: 434
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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 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.

Primary outcomes:
measure: Alzheimer's Disease Assessment Scale - cognitive subscale
timeFrame: Measurements up through 24 weeks
Secondary outcomes:
measure: Mini Mental Status Exam
timeFrame: Measurements up through 24 weeks
measure: Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
timeFrame: Measurements up through 24 weeks
measure: DEMentia Quality of Life (DEMQOL)
timeFrame: Measurements up through 24 weeks
measure: Clinician Interview-Based Impression of Change - plus (CIBIC-plus)
timeFrame: Measurements up through 24 weeks
measure: Neuropsychiatry Inventory (NPI)
timeFrame: Measurements up through 24 weeks
measure: Partner-Patient Questionnaire for Shared Activities (PPQSA)
timeFrame: Measurements up through 24 weeks
measure: Resource Use in Dementia (RUD-Lite)
timeFrame: Measurements up through 24 weeks
measure: EuroQol-5D Questionnaires
timeFrame: Measurements up through 24 weeks
measure: Wechsler Memory Scale-III (WMS-III) Working Memory Index
timeFrame: Measurements up through 18 weeks
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Site Reference ID/Investigator# 66528
state: California
city: Long Beach
country: United States
facility: Site Reference ID/Investigator# 69602
state: California
city: San Francisco
country: United States
facility: Site Reference ID/Investigator# 66527
state: California
city: Hamden
country: United States
facility: Site Reference ID/Investigator# 66530
state: Connecticut
city: Delray Beach
country: United States
facility: Site Reference ID/Investigator# 66522
state: Florida
city: Orlando
country: United States
facility: Site Reference ID/Investigator# 66524
state: Florida
city: Tampa
country: United States
facility: Site Reference ID/Investigator# 66531
state: Florida
city: West Palm Beach
country: United States
facility: Site Reference ID/Investigator# 66529
state: Florida
city: Elk Grove Village
country: United States
facility: Site Reference ID/Investigator# 66526
state: Illinois
city: Staten Island
country: United States
facility: Site Reference ID/Investigator# 66525
state: New York
city: Bennington
country: United States
facility: Site Reference ID/Investigator# 66523
state: Vermont
city: Gatineau
country: Canada
facility: Site Reference ID/Investigator# 71793
city: Montreal
country: Canada
facility: Site Reference ID/Investigator# 71794
city: Peterborough
country: Canada
facility: Site Reference ID/Investigator# 71798
city: Toronto
country: Canada
facility: Site Reference ID/Investigator# 71795
city: Verdun
country: Canada
facility: Site Reference ID/Investigator# 71796
city: Dijon Cedex
country: France
facility: Site Reference ID/Investigator# 71573
city: Limoges Cedex
country: France
facility: Site Reference ID/Investigator# 77833
city: Paris Cedex 10
country: France
facility: Site Reference ID/Investigator# 68704
city: Paris
country: France
facility: Site Reference ID/Investigator# 68706
city: Toulouse Cedex 9
country: France
facility: Site Reference ID/Investigator# 68705
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 68768
city: Freiburg
country: Germany
facility: Site Reference ID/Investigator# 68764
city: Huettenberg
country: Germany
facility: Site Reference ID/Investigator# 68767
city: Mittweida
country: Germany
facility: Site Reference ID/Investigator# 69960
city: Munich
country: Germany
facility: Site Reference ID/Investigator# 68765
city: Schwerin
country: Germany
facility: Site Reference ID/Investigator# 69959
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 68730
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 68732
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 68733
city: Haidari, Athens
country: Greece
facility: Site Reference ID/Investigator# 68731
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 68729
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 68735
city: Belville
country: South Africa
facility: Site Reference ID/Investigator# 67586
city: Cape Town
country: South Africa
facility: Site Reference ID/Investigator# 67582
city: George
country: South Africa
facility: Site Reference ID/Investigator# 67584
city: Johannesburg
country: South Africa
facility: Site Reference ID/Investigator# 67585
city: Rosebank
country: South Africa
facility: Site Reference ID/Investigator# 67583
city: Bath
country: United Kingdom
facility: Site Reference ID/Investigator# 67787
city: Glasgow
country: United Kingdom
facility: Site Reference ID/Investigator# 67784
city: London
country: United Kingdom
facility: Site Reference ID/Investigator# 67786
city: Manchester
country: United Kingdom
facility: Site Reference ID/Investigator# 67785
city: Warrington
country: United Kingdom
facility: Site Reference ID/Investigator# 67783
Study officials:
affiliation: AbbVie
name: Laura Gault, MD
role: STUDY_DIRECTOR
References:
citation: 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.