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A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of ABBV-916 in Subjects with Early Alzheimer's Disease
EU CTIS ID: 2022-500691-59-00
What this study is testing
Primary objective: To evaluate the safety, tolerability, and amyloid reduction associated with ABBV-916 after repeated intravenous administrations in subjects with early AD.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult male or female, 50 to 90 years of age, inclusive, at time of consent.
- Subjects must have, in the investigator's opinion, adequate premorbid literacy, visual or auditory acuity to complete the required neuropsychological testing.
- Subjects will have an MMSE score of 20 to 28 (inclusive) at Screening, a blood-based biomarker result with a value consistent with amyloid PET positivity, and amyloid PET scan results consistent with amyloid pathology (as determined by visual assessment and a centiloid value of 37 or higher).
You likely can't join if
- Subject must not have any elective surgery from 2 weeks prior to randomization or anticipated to be performed through the end of the study.
- Subject must not be currently enrolled in another clinical study or previously enrolled in this study.
- Subject's screening MRI must not show evidence of or significant abnormality that would suggest another potential etiology for progressive dementia or a clinically significant finding that may impact the subject's ability to safely participate in the study.
- Subjects must not have hypersensitivity to mAb treatments, protein derived from a mAb, or immunoglobulin therapy.
- Subject must not have a history of drug or alcohol abuse within 2 years prior to study drug administration.
- Subject must not have known history of, or positive Screening test result for hepatitis C virus or hepatitis B virus, human immunodeficiency virus (HIV) or other immunodeficiencies.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- Canada
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; Canada; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.