Status:
COMPLETED
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
Conditions:
Alzheimer's Disease (AD)
Eligibility:
All Genders
50-90 years
Phase:
PHASE2
Brief Summary
Alzheimer's disease (AD) is a progressive, irreversible neurological disorder and is the most common cause of dementia in the elderly population. Clinical symptoms of the disease may begin with occasi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2025
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT05291234
Start Date
August 15 2022
End Date
November 19 2025
Last Update
December 10 2025
Active Locations (32)
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1
Tucson Neuroscience Research /ID# 244957
Tucson, Arizona, United States, 85710-6152
2
Irvine Clinical Research /ID# 239469
Irvine, California, United States, 92614
3
Artemis Institute for Clinical Research - San Diego /ID# 244508
San Diego, California, United States, 92103-2204
4
Pacific Research Network, Inc. /ID# 244083
San Diego, California, United States, 92103