A Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Participants With Early Alzheimer's Disease
Purpose
This study seeks to evaluate the efficacy and safety of ABBV-8E12 in participants with early Alzheimer's disease (AD).
Condition
- Alzheimer's Disease
Eligibility
- Eligible Ages
- Between 55 Years and 85 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Subject who meets the National Institute on Aging and the Alzheimer's Association (NIA-AA) clinical criteria for mild cognitive impairment or probable AD, and have: - Clinical Dementia Rating (CDR)-Global Score of 0.5 - Mini-Mental State Examination (MMSE) score of 22 to 30, inclusive - Repeatable Battery for the Assessment of Neuropsychological Status-Delayed Memory Index (RBANS - DMI) score of 85 or lower - Subject has a positive amyloid positron emission tomography (PET) scan. - Subject has a Modified Hachinski Ischemic Scale (MHIS) score of ≤ 4. - The subject has an identified, reliable, study partner (e.g., family member). - If using medications to treat symptoms related to AD, doses must be stable for at least 12 weeks prior to randomization.
Exclusion Criteria
- Subject has any contraindications or inability to tolerate brain magnetic resonance imaging (MRI), PET scans or lumbar puncture. - Subject has evidence of any other clinically significant neurological disorder other than early AD. - In the opinion of the investigator, the subject has any clinically significant or uncontrolled medical or psychiatric illness, or has had an infection requiring medical intervention in the past 30 days. - Subject has had a myocardial infarction, unstable angina, stroke, transient ischemic attack or required intervention for any of these conditions within 6 months of Screening.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Placebo |
Placebo for ABBV-8E12 every 4 weeks for 96 weeks |
|
|
Experimental ABBV-8E12 300 mg |
ABBV-8E12 300 mg every 4 weeks for 96 weeks |
|
|
Experimental ABBV-8E12 1000 mg |
ABBV-8E12 1000 mg every 4 weeks for 96 weeks |
|
|
Experimental ABBV-8E12 2000 mg |
ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
More Details
- Status
- Completed
- Sponsor
- AbbVie