ABT-126 in Subjects with Mild to Moderate Alzheimer's Disease
ABT-126 in Subjects with Mild to Moderate Alzheimer's Disease
Overall Status:
Recruiting
Brief Description:
This study will evaluate the efficacy and safety of the experimental drug ABT-126 as a new treatment for people with mild to moderate Alzheimer's disease. The effects of three different doses of ABT-126 will be compared to the effects of donepezil and a placebo.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
55 Years | 90 Years | Both | No |
Inclusion Criteria:
- Diagnosis of probable Alzheimer's disease
- Mini-Mental Status Examination (MMSE) score of 10-24, inclusive
- Cornell Scale for Depression in Dementia (CSDD) score of 10 or less
- Modified Hachinski Ischemic Scale (MHIS) score of 4 or less
- With the exception of Alzheimer's and stable medical conditions, good general health, based on the results of medical history, physical examination, vital signs, laboratory profile, and electrocardiogram
- Reliable caregiver who can provide support and ensure compliance with the study medication and procedures, and provide accurate information about the participant's status during the study
Exclusion Criteria:
- Currently taking or has taken medication for the treatment of Alzheimer's disease or dementia within 60 days prior to screening
- Participating in cognitive therapy for the treatment of Alzheimer's or dementia
- Clinically significant abnormal laboratory values at initial screening
- History of any significant neurologic disease other than Alzheimer's, 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
- Any clinically significant uncontrolled medical or psychiatric illness
- Known hypersensitivity or intolerance to donepezil that led to discontinuation or a known history of donepezil treatment failure
Detailed Description:
This Phase II study is designed to evaluate the efficacy and safety of the experimental drug ABT-126. Participants will receive one of three different doses of the drug (low, middle, and high); donepezil, an approved Alzheimer's disease treatment; or a placebo. The treatment period will last 24 weeks. Participants may be eligible to particpate in an extension study; see NCT01676935.
Central Contact Information:
For more information about this study or the participating sites, contact Alison Torres, 847-938-2226, alison.torres@abbott.com or Lindsey Bensman, 847-935-1821, lindsey.bensman@abbott.com
Locations:
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 41.4305881, -72.9106202 | Hamden | Connecticut | 06518 | Withdrawn | Name: Phone: | |
Geolocation is 26.4647478, -80.109357 | Delray Beach | Florida | 33445 | 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 40.0959438, -75.1251743 | Jenkintown | Pennsylvania | 19046 | Recruiting | Name: Phone: | |
Geolocation is 33.8954726, -98.544636 | Wichita Falls | Texas | 76309 | Recruiting | Name: Phone: | |
Geolocation is 42.878094, -73.1968001 | Bennington | Vermont | 05201 | 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 |
Locations
ClinicalTrials.gov ID
NCT01527916 (follow link to view full record on ct.gov in new window)
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 Start Date:
February 2012
Study End Date:
November 2013
Disease Stage:
Early
Middle
Enrollment:
410
