Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05291234 | 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 | PHASE2 | COMPLETED | 106 | — | — | Aug 15, 2022 | Nov 19, 2025 | Dec 10, 2025 | 32 | United States |
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Cmax of ABBV-916 will be determined.
Tmax of ABBV-916 will be determined.
Apparent terminal phase elimination rate constant (β) of ABBV-916 will be determined.
T1/2 of ABBV-916 will be determined.
Ctrough of ABBV-916 will be determined.
AUC of ABBV-916 will be determined.
The central value for ratio of ABBV-916 concentration in cerebrospinal fluid (CSF) to that in serum will be estimated for evaluation of the fraction of ABBV-916 crossing the blood brain barrier.
Antidrug antibody (ADA) classification and titers for positive ADA samples will be determined.
Change from baseline in brain amyloid plaque deposition (amyloid centiloid value) is measured by amyloid positron emission tomography (PET) scan.
| Arm | Type | Description |
|---|---|---|
| Stage A: ABBV-916 | EXPERIMENTAL | Participants will receive ABBV-916 for 24 weeks. Participants at the end of 24 weeks will have the option of participating in the 2-year Extension Period. |
| Stage A: Placebo for ABBV-916 | PLACEBO_COMPARATOR | Participants will receive Placebo for 24 weeks. Participants at the end of 24 weeks will have the option of participating in the 2-year Extension Period. |
| Stage B: ABBV-916 Dose A | EXPERIMENTAL | Participants will receive ABBV-916 Dose A for 24 weeks. Participants at the end of 24 weeks will have the option of participating in the 2-year Extension Period. |
| Stage B: Placebo for ABBV-916 | PLACEBO_COMPARATOR | Participants will receive Placebo for 24 weeks. Participants at the end of 24 weeks will have the option of participating in the 2-year Extension Period. |
| Stage B: ABBV-916 Dose B | EXPERIMENTAL | Participants will receive ABBV-916 Dose B for 24 weeks. Participants at the end of 24 weeks will have the option of participating in the 2-year Extension Period. |
| Name | Type | Description |
|---|---|---|
| ABBV-916 | DRUG | Intravenous administration |
| Placebo | DRUG | Intravenous administration |
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 biomarke...