- Study Director: Peter Ljubenkov, MD
- Sponsor: AbbVie
- Status: Active, not recruiting
- Official Study Title: A Phase 2 Multiple Dose, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Subjects With Early Alzheimer’s Disease
- ClinicalTrials.gov Identifier: NCT02880956
- Conditions Studied: Alzheimer’s disease (AD)
- Intervention: ABBV-8E12 and placebo
- Phase: Phase 2
- Duration of Participation: Up to 128 weeks
Purpose of the Study
This study seeks to evaluate the efficacy and safety of ABBV-8E12 in subjects with early Alzheimer’s disease.
Eligibility
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.
What to Expect
Testing: Neurological and physical examinations, MRIs, PET scans, lumbar puncture, cognitive testing and neuropsychiatric assessments, EKGs, blood and urine specimen collection, and vital signs
The Frequency of Visits: Every 4 weeks during double-blind treatment period
Materials Needed Before Evaluation: Prior to participating in the trial, the patient will need a confirmed diagnosis of mild cognitive impairment (MCI) or Alzheimer’s disease.
Costs: No costs will be charged for any of the study procedures. Parking will be validated at UCSF public garages for all study visits, and participants will be reimbursed up to $225 during the screening process and up to $175 for other scheduled visits to help defray any incidental expenses incurred in the course of participating in this study.
Contact Information
Coordinator: Maryellen Barillas – [email protected], 415.476.2941
Clinical Trials Nurse: Mary Koestler, RN, PhD, CCRC – [email protected], 415.476.0661