Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-916 · 1 trial · 1 indication
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...
Top 20 of 30 competitors
ABBV-916 is an investigational small molecule being developed by AbbVie Inc. for Alzheimer's disease. It is a Phase 2 candidate studied in adults aged 50 to 90 with early Alzheimer's disease. It is not yet approved for any use and remains in clinical development.
ABBV-916 is being studied for the treatment of early Alzheimer's disease in adults aged 50 to 90. The Phase 2 study enrolled participants with early Alzheimer's disease and assessed brain amyloid plaque clearance. It is an investigational therapy and has not been approved for treating Alzheimer's disease.
ABBV-916 is developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the Phase 2 clinical program evaluating the small molecule in early Alzheimer's disease.
ABBV-916 is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The drug is investigational and has not received FDA approval for Alzheimer's disease or any other indication.
ABBV-916 has been evaluated in one Phase 2 trial, NCT05291234, titled a study to assess safety of ABBV-916 and how intravenous ABBV-916 moves through the body and affects brain amyloid plaque clearance in adults aged 50 to 90 with early Alzheimer's disease. The trial was completed and enrolled 106 participants in the United States.
The Phase 2 trial NCT05291234 was a randomized, double-blind, placebo-controlled study of intravenous ABBV-916 in 106 adults aged 50 to 90 with early Alzheimer's disease. It enrolled biomarker-selected participants, did not include healthy volunteers, and was conducted in the United States. The trial has been completed.