Alzheimer's Disease
Conditions
Brief summary
This is a efficacy and safety study evaluating 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 260 adults with mild-to-moderate Alzheimer's disease (AD). Subjects will be randomized to one of the four treatment groups (ABT-126, donepezil, or placebo) for a 12-week Treatment Period. Acronyms are listed in the secondary outcome section, below, you will find a list of the acronyms defined: * MMSE - Mini Mental Status Exam * QoL-AD - Quality of Life - Alzheimer's Disease * CIBIC-plus - Clinician Interview-Based Impression of Change * NPI - Neuropsychiatric Inventory * CSDD - The Cornell Scale for depression in Dementia * ADCS-ADL - Alzheimer's Disease Cooperative Study - Activities of Daily Living
Interventions
DRUGPlacebo
Placebo intervention
DRUGABT-126
Experimental intervention
DRUGdonepezil
Active comparator intervention
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* The subject is a male or female between the ages of 55 and 90 years, inclusive, at Screening Visit 1. * The subject meets the NINCDS/ADRDA criteria for probable AD. * The subject has a Mini-Mental Status Examination (MMSE) total score of 10 to 24, inclusive, at Screening Visit 1. * The subject has a Modified Hachinski Ischemic Scale (MHIS) score of less than or equal to 4 at Screening Visit 1. * If female, subject must be postmenopausal for at least two years or surgically sterile * The subject has an identified, reliable, caregiver.
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 * The subject has a history of any significant neurologic disease other than AD. * In the opinion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness. * The subject has reported history of discontinuation of donepezil due to lack of efficacy. * The subject has a history of intolerance or adverse reaction to donepezil that led to discontinuation. * The subject has a known hypersensitivity to donepezil, piperidine derivatives, or any of the excipients in either donepezil hydrochloride or ABT-126 formulations. * Patient uses non-prescribed drugs of abuse or has a history of drug or alcohol abuse/dependence. * Subjects with AST and ALT values at Screening Visit 1 that are greater than or equal to 1.5-fold the upper limit of normal (ULN).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ADAS-Cog - Alzheimer's Disease Assessment Scale Cognition portion | Measurements up through 12 weeks. |
Secondary
| Measure | Time frame |
|---|---|
| MMSE, QoL-AD, CIBIC-plus, NPI, CSDD, ADAS-Cog (13 item) and ADCS-ADL. Note: Acronyms are fully defined in the area titled Detailed Description. | Measurements up through 12 weeks. |
Countries
Bulgaria, Czechia, Slovakia, South Africa, United Kingdom, United States
Outcome results
None listed