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

Study Identifier
M22-721
CT.gov Identifier
NCT05291234
EudraCT Identifier
Not available
EUCTIS ID
2022-500691-59-00
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Alzheimer's Disease
    • Study Drug
  • ABBV-916
  • Placebo
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    50 - 90 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * 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 Criteria:
    * 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.

    Protocol 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 occasional forgetfulness such as misplacement of items, forgetting important dates or events, and may progress to noticeable memory loss, increased confusion and agitation, and eventually, loss of independence and non-responsiveness. This study will assess how safe and effective ABBV-916 is in treating early AD. Adverse events, change in disease activity, and how ABBV-916 moves through body of participants will be assessed.

    ABBV-916 is an investigational drug being developed for the treatment of early AD. This study is conducted in 2 stages. Stage A is a multiple ascending dose study. There is a 1 in 4 chance that participants are assigned to receive placebo. Stage B is a proof-of-concept study. In Stage B, there is a 1 in 5 chance that participants will be assigned to receive placebo. The first 6 months of this study are "double-blind," which means that neither the trial participant nor the study doctors know which treatments will be given. This will be followed by a 2-year extension period in which all participants will receive ABBV-916. Approximately 195 participants aged 50-90 years will be enrolled in about 90 sites across the world.

    Participants will receive intravenous (IV) doses of ABBV-916 or placebo once every 4 weeks (Q4W) for 24 weeks and will be followed for an additional 16 weeks. Participants will have the option of participating in a 2-year, open-label, Extension Period receiving IV ABBV-916.

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, magnetic resonance imaging (MRI), blood tests, checking for side effects and completing questionnaires.

    Study Locations

    Location
    Status
    Location
    Tucson Neuroscience Research /ID# 244957
    Tucson, Arizona, United States, 85710-6152
    Status
    Not applicable
    Location
    Irvine Clinical Research /ID# 239469
    Irvine, California, United States, 92614
    Status
    Not applicable
    Location
    Artemis Institute for Clinical Research - San Diego /ID# 244508
    San Diego, California, United States, 92103-2204
    Status
    Not applicable
    Location
    Pacific Research Network, Inc. /ID# 244083
    San Diego, California, United States, 92103
    Status
    Not applicable
    Location
    Syrentis Clinical Research /ID# 239682
    Santa Ana, California, United States, 92705
    Status
    Not applicable
    Location
    Aventura Neurological Associates /ID# 243892
    Aventura, Florida, United States, 33180
    Status
    Not applicable
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