Alzheimer's Disease Education and Referral Center

ABT-126 in Subjects with Alzheimer's Disease on Acetylcholinesterase Inhibitors

ABT-126 in Subjects with Alzheimer's Disease on Acetylcholinesterase Inhibitors

Overall Status: 
Completed
Brief Description: 

This Phase II efficacy and safety study will evaluate the drug ABT-126 as a new treatment for people with mild to moderate Alzheimer's disease.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
55 Years
90 Years
Both
No
Inclusion Criteria: 

  • Meets NINCDS/ADRDA criteria for probable Alzheimer's disease
  • Taking stable dose of an acetylcholinesterase inhibitor (donepezil or rivastigmine) for at least 90 days prior to screening
  • Mini-Mental Status Examination (MMSE) total score of 12 to 24; Cornell Scale for Depression in Dementia (CSDD) score of 10 or less; Modified Hachinski Ischemic Scale (MHIS) score of 4 or less
  • Good general health, based on results of medical history, physical examination, vital signs, laboratory profile, and electrocardiogram
  • Caregiver who will provide support, ensure compliance with study medication and procedures, and provide accurate information about the subject's status during the study

Exclusion Criteria: 

  • Subject has taken galantamine or memantine within 60 days prior to screening
  • Clinically significant abnormal laboratory values at screening
  • 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, seizures
  • Mental retardation
  • History of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities
  • Clinically significant uncontrolled medical or psychiatric illness.

Detailed Description: 

This is a Phase II study designed to evaluate the efficacy and safety of ABT-126 in older adults with mild to moderate Alzheimer's disease who are taking stable doses of acetylcholinesterase inhibitors. Participants will be randomized to receive one of two ABT-126 doses or a placebo for a 24-week treatment period. Participants in this study may be eligible to take part in a related extension study; see NCT01690195 in ClinicalTrials.gov for details.

Central Contact Information: 

For more information about this clinical trial or the study sites, call or email the study contacts Alison Torres (847-938-2226; alison.torres@abbott.com) or Betty Prine (847-937-6928; betty.prine@abbott.com).

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 36.8638688, -119.7715563

Site Reference ID/Investigator# 66528
Fresno
California
93720
Name:
Phone:

Geolocation is 33.8065036, -118.1912538

Site Reference ID/Investigator# 69602
Long Beach
California
90806
Name:
Phone:

Geolocation is 37.7929789, -122.4212424

Site Reference ID/Investigator# 66527
San Francisco
California
94109-4841
Name:
Phone:

Geolocation is 41.4305881, -72.9106202

Site Reference ID/Investigator# 66530
Hamden
Connecticut
06518
Name:
Phone:

Geolocation is 26.4647478, -80.109357

Site Reference ID/Investigator# 66522
Delray Beach
Florida
33445
Name:
Phone:

Geolocation is 28.5085825, -81.3564411

Site Reference ID/Investigator# 66524
Orlando
Florida
32806
Name:
Phone:

Geolocation is 28.0869646, -82.4698603

Site Reference ID/Investigator# 66531
Tampa
Florida
33613
Name:
Phone:

Geolocation is 26.7619563, -80.1037721

Site Reference ID/Investigator# 66529
West Palm Beach
Florida
33407
Name:
Phone:

Geolocation is 42.0039178, -87.9703461

Site Reference ID/Investigator# 66526
Elk Grove Village
Illinois
60007
Name:
Phone:

Geolocation is 40.555548, -74.1827119

Site Reference ID/Investigator# 66525
Staten Island
New York
10312
Name:
Phone:

Geolocation is 42.878094, -73.1968001

Site Reference ID/Investigator# 66523
Bennington
Vermont
05201
Name:
Phone:

Geolocation is 45.4248921, -75.7406004

Site Reference ID/Investigator# 71793
Gatineau
None
J9A 1K7
Name:
Phone:

Geolocation is 45.4976084, -73.6292768

Site Reference ID/Investigator# 71794
Montreal
None
H3T 1E2
Name:
Phone:

Geolocation is 44.3073347, -78.3218108

Site Reference ID/Investigator# 71798
Peterborough
None
K9H 2P4
Name:
Phone:

Geolocation is 43.7585342, -79.3535081

Site Reference ID/Investigator# 71795
Toronto
None
M3B 2S7
Name:
Phone:

Geolocation is 45.4420201, -73.5800493

Site Reference ID/Investigator# 71796
Verdun
None
H4H 1R3
Name:
Phone:
Lead Sponsor: 
Agency
AbbVie (prior sponsor, Abbott)
Collaborator Sponsor: 
Facility Investigators: 
NameRoleAffiliation
Laura Gault, MD
Study Director
Abbott
Study Contact: 
NamePhoneEmail
Alison Torres
847-938-2226
Betty Prine
847-937-6928
Locations
 
 
ClinicalTrials.gov ID 
NCT01549834 (follow link to view full record on ct.gov in new window)
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 Start Date: 
March 2012
Study End Date: 
October 2013
Disease Stage: 
Early
Middle
Enrollment: 
420