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...
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ABBV-916 is an investigational small molecule being developed for the treatment of Alzheimer's Disease (AD). It is designed to be administered intravenously and is being studied in adult participants aged 50 to 90 years with early Alzheimer's Disease.
ABBV-916 is being studied to assess its effect on brain amyloid plaque clearance in participants with early Alzheimer's Disease. The drug is administered intravenously, and its mechanism involves targeting amyloid plaques, which are a hallmark of Alzheimer's pathology.
ABBV-916 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.
ABBV-916 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness in treating early Alzheimer's Disease.
ABBV-916 has one completed Phase 2 clinical trial, identified as NCT05291234. This study assessed the safety of ABBV-916 and how it moves through the body and affects brain amyloid plaque clearance in 106 adult participants with early Alzheimer's Disease.
ABBV-916 is a unique investigational compound developed by AbbVie Inc. It is not known to be the same as any other marketed drug. It is being studied specifically for its potential to clear amyloid plaques in early Alzheimer's Disease.