Clinical trial NCT01527916: Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-02-07
Enrollment: 438
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 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.

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.
* 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.

Primary outcomes:
measure: Alzheimer's Disease Assessment Scale - cognitive subscale
timeFrame: Measurements up through 24 weeks
Secondary outcomes:
measure: Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
timeFrame: Measurements up through 24 weeks
measure: Mini Mental Status Exam (MMSE)
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 24 weeks
Other outcomes:
Locations:
city: Delray Beach
country: United States
facility: Site Reference ID/Investigator# 56503
state: Florida
city: Tampa
country: United States
facility: Site Reference ID/Investigator# 56518
state: Florida
city: West Palm Beach
country: United States
facility: Site Reference ID/Investigator# 56514
state: Florida
city: Elk Grove Village
country: United States
facility: Site Reference ID/Investigator# 62611
state: Illinois
city: Staten Island
country: United States
facility: Site Reference ID/Investigator# 56506
state: New York
city: Jenkintown
country: United States
facility: Site Reference ID/Investigator# 82994
state: Pennsylvania
city: Wichita Falls
country: United States
facility: Site Reference ID/Investigator# 77636
state: Texas
city: Bennington
country: United States
facility: Site Reference ID/Investigator# 56504
state: Vermont
city: Gdynia
country: Poland
facility: Site Reference ID/Investigator# 62565
city: Poznan
country: Poland
facility: Site Reference ID/Investigator# 62563
city: Szczecin
country: Poland
facility: Site Reference ID/Investigator# 62562
city: Kazan
country: Russian Federation
facility: Site Reference ID/Investigator# 60945
city: Kazan
country: Russian Federation
facility: Site Reference ID/Investigator# 60955
city: Kirov
country: Russian Federation
facility: Site Reference ID/Investigator# 60954
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 60951
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 60959
city: Novosibirsk
country: Russian Federation
facility: Site Reference ID/Investigator# 60946
city: Saratov
country: Russian Federation
facility: Site Reference ID/Investigator# 60950
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 60947
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 60958
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 60949
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 60952
city: Belville
country: South Africa
facility: Site Reference ID/Investigator# 60911
city: Cape Town
country: South Africa
facility: Site Reference ID/Investigator# 76073
city: George
country: South Africa
facility: Site Reference ID/Investigator# 60912
city: Johannesburg
country: South Africa
facility: Site Reference ID/Investigator# 60910
city: Donetsk
country: Ukraine
facility: Site Reference ID/Investigator# 60909
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 60906
city: Poltava
country: Ukraine
facility: Site Reference ID/Investigator# 60905
city: Bath
country: United Kingdom
facility: Site Reference ID/Investigator# 60960
city: Blackburn
country: United Kingdom
facility: Site Reference ID/Investigator# 60963
city: Glasgow
country: United Kingdom
facility: Site Reference ID/Investigator# 60962
city: London
country: United Kingdom
facility: Site Reference ID/Investigator# 60961
Study officials:
affiliation: AbbVie
name: Laura Gault, MD
role: STUDY_DIRECTOR
References:
citation: 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.