ABT-126 in Subjects with Alzheimer's Disease on Acetylcholinesterase Inhibitors
ABT-126 in Subjects with Alzheimer's Disease on Acetylcholinesterase Inhibitors
Overall Status:
Recruiting
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 Age | Max Age | Gender | Healthy 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 | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 36.8638688, -119.7715563 | Fresno | California | 93720 | Completed | Name: Phone: | |
Geolocation is 33.8065036, -118.1912538 | Long Beach | California | 90806 | Recruiting | Name: Phone: | |
Geolocation is 37.7929789, -122.4212424 | San Francisco | California | 94109-4841 | Recruiting | Name: Phone: | |
Geolocation is 41.4305881, -72.9106202 | Hamden | Connecticut | 06518 | Recruiting | Name: Phone: | |
Geolocation is 26.4647478, -80.109357 | Delray Beach | Florida | 33445 | Recruiting | Name: Phone: | |
Geolocation is 28.5085825, -81.3564411 | Orlando | Florida | 32806 | Recruiting | Name: Phone: | |
Geolocation is 28.0869646, -82.4698603 | Tampa | Florida | 33613 | Completed | Name: Phone: | |
Geolocation is 26.7619563, -80.1037721 | West Palm Beach | Florida | 33407 | Recruiting | Name: Phone: | |
Geolocation is 42.0039178, -87.9703461 | Elk Grove Village | Illinois | 60007 | Recruiting | Name: Phone: | |
Geolocation is 40.555548, -74.1827119 | Staten Island | New York | 10312 | Recruiting | Name: Phone: | |
Geolocation is 42.878094, -73.1968001 | Bennington | Vermont | 05201 | Recruiting | Name: Phone: | |
Geolocation is 45.4248921, -75.7406004 | Gatineau | None | J9A 1K7 | Recruiting | Name: Phone: | |
Geolocation is 45.4976084, -73.6292768 | Montreal | None | H3T 1E2 | Recruiting | Name: Phone: | |
Geolocation is 44.3073347, -78.3218108 | Peterborough | None | K9H 2P4 | Recruiting | Name: Phone: | |
Geolocation is 43.7585342, -79.3535081 | Toronto | None | M3B 2S7 | Recruiting | Name: Phone: | |
Geolocation is 45.4420201, -73.5800493 | Verdun | None | H4H 1R3 | Recruiting | Name: Phone: |
Lead Sponsor:
| Agency |
|---|
AbbVie (prior sponsor, Abbott) |
Collaborator Sponsor:
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Laura Gault, MD | Study Director | Abbott |
Study Contact:
| Name | Phone | |
|---|---|---|
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
