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Also known as Tilavonemab
ABBV-8E12 · 2 trials · 2 indications
The CDR-SB is a numeric scale used to quantify the severity of symptoms of dementia. A qualified health professional assesses a participant's cognitive and functional performance in 6 areas: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The CDR scale gives a score from 0 to 3 for each of the 6 areas, with a lower value being desirable. The sum of these 6 areas, the CDR-SB score, can range from 0 to 18, with a lower value being desirable.
A TEAE was defined as an adverse event (AE) that began on or after the first study drug dose date and no more than 20 weeks after the last dose of study drug. An adverse event (AE) was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. Serious AEs (SAEs) were defined as an event that results in death, is life-threatening, results in hospitalization or prolongs hospitalization, is a congenital abnormality, results in persistent or significant disability/incapacity, or is an important medical event. Events were rated in severity as mild, moderate, or severe, and were categorized as having a reasonable possibility or no reasonable possibility of relationship to study drug.
Adverse events and serious adverse events will be monitored throughout the dosing period and for approximately 20 weeks after the last dose.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo for ABBV-8E12 every 4 weeks for 96 weeks |
| ABBV-8E12 300 mg | EXPERIMENTAL | ABBV-8E12 300 mg every 4 weeks for 96 weeks |
| ABBV-8E12 1000 mg | EXPERIMENTAL | ABBV-8E12 1000 mg every 4 weeks for 96 weeks |
| ABBV-8E12 2000 mg | EXPERIMENTAL | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
| ABBV-8E12 | EXPERIMENTAL | ABBV-8E12 administered by intravenous (IV) infusion. |
| Name | Type | Description |
|---|---|---|
| ABBV-8E12 | DRUG | ABBV-8E12 solution for IV infusion |
| placebo for ABBV-8E12 | DRUG | placebo solution for intravenous (IV) infusion |
Inclusion Criteria: * Subject who meets the National Institute on Aging and the Alzheimer's Association (NIA-AA) clinical criteria for mild cognitive impairment or probable AD, and have: * Clinical Dementia Rating (CDR)-Global Score of 0.5 * Mini-Mental State Examination (MMSE) score of 22 to ...
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ABBV-8E12 is an investigational small molecule being developed for Alzheimer's Disease and Progressive Supranuclear Palsy (PSP). It is in Phase 2 clinical development for early Alzheimer's Disease and has been studied in PSP. The drug is not approved and remains under clinical investigation.
ABBV-8E12 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting clinical trials to evaluate the drug's efficacy and safety in neurological conditions.
ABBV-8E12 is in Phase 2 clinical development for early Alzheimer's Disease. A Phase 1 extension study for Progressive Supranuclear Palsy has also been completed. The drug is investigational and has not received FDA approval.
ABBV-8E12 has been studied in two completed trials. NCT02880956 was a Phase 2, randomized, double-blind, placebo-controlled study in 453 participants with early Alzheimer's Disease. NCT03413319 was a Phase 1 extension study in 3 patients with Progressive Supranuclear Palsy.
ABBV-8E12 is associated with the compound previously known as C2N-8E12, as indicated by the extension study title referencing study C2N-8E12-WW-104. The drug is being developed by AbbVie under the name ABBV-8E12.