A Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Subjects With Early Alzheimer's Disease

• Status: Completed
• Trial end date: 2021-07-05
• Target enrollment: 0
• Participant gender: All

Summary

This study seeks to evaluate the efficacy and safety of ABBV-8E12 in subjects with Early Alzheimer's Disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Tilavonemab

Criteria

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.