A Study to Assess Safety of ABBV-916 and How Intravenous ABBV-916 Moves Through Body and Affects Brain Amyloid Plaque Clearance in Adult Participants (Aged 50-90 Years) With Early Alzheimer's Disease

Lead Sponsor

AbbVie

Age

50 - 90 years

Sex

ALL

Healthy Volunteers

No

•Diagnosis of Stage 3 or Stage 4 Alzheimer's disease (AD) based on the 2018 National Institute on Aging (NIA)-Alzheimer's Association (AA) Research Framework Criteria.
•* Mini-Mental State Examination (MMSE) score of 20 to 28, inclusive, at Screening.
•* Blood-based biomarker results with a value consistent with amyloid positron emission tomography (PET) positivity. The biomarker will be chosen by the sponsor and described in the Laboratory Manual. Biomarker results will not be required for eligibility if the participant has a positive Amyloid PET scan meeting the central reader criteria.
•Amyloid PET scan results consistent with amyloid pathology.
•Stage B: Participants must have a study partner who spends a minimum average of 10 hours per week with the participant.

•Significant pathological findings on brain MRI at screening including, but not limited to, evidence of vasogenic edema, 4 or more microhemorrhages, any macrohemorrhages, any superficial siderosis, or severe white matter disease.
•Any anticoagulants or have a bleeding disorder that is not adequately controlled.

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