Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-552 · 1 trial · 1 indication
The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 \[1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task\] and includes 3 additional tasks \[12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning\], for increased sensitivity in mild cognitive impairment (MCI) patients. The Total Score of the ADAS-Cog-14 ranges from 0 to 90, with a higher score representing greater impairment.
| Arm | Type | Description |
|---|---|---|
| ABBV-552: 1 mg | EXPERIMENTAL | Participants will receive 1 mg of ABBV-552 once daily (QD) for 12 weeks. |
| ABBV-552: 5 mg | EXPERIMENTAL | Participants will receive 5 mg of ABBV-552 QD for 12 weeks. |
| ABBV-552: 15 mg | EXPERIMENTAL | Participants will receive 5 mg of ABBV-552 QD for 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo for ABBV-552 QD for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| ABBV-552 | DRUG | Oral Capsule |
| Placebo for ABBV-552 | DRUG | Oral Capsule |
Inclusion Criteria: * Diagnosis of probable Alzheimer's disease according to the National Institute of Aging-Alzheimer's Association (NIA-AA) (2011) criteria. * Mini-Mental State Examination (MMSE) score of 20 to 26, a Clinical Dementia Rating (CDR) global score of 0.5 or 1.0, with a CDR memory sco...
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ABBV-552 is an investigational oral small molecule being developed by AbbVie Inc. for Alzheimer's disease. It is a capsule formulation that has been studied in a Phase 2 clinical trial in participants with mild Alzheimer's disease. It is not approved for any indication and remains in clinical development.
ABBV-552 is being studied for the treatment of mild Alzheimer's disease. The Phase 2 trial enrolled participants aged 50 to 90 years with mild Alzheimer's disease. It is an investigational therapy and has not been approved for use in Alzheimer's disease or any other condition.
ABBV-552 is developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical program evaluating the oral small molecule in Alzheimer's disease.
ABBV-552 is in Phase 2 development. One Phase 2 trial, NCT05771428, has been completed. The study was randomized, double-blind, and placebo-controlled, enrolling 263 participants with mild Alzheimer's disease across the United States, Australia, Germany, Japan, New Zealand, Spain, and the United Kingdom.
ABBV-552 has been evaluated in one Phase 2 trial, NCT05771428, titled a study to assess adverse events, change in disease activity, and how oral ABBV-552 capsules move through the body of participants aged 50 to 90 years with mild Alzheimer's disease. The trial is completed and enrolled 263 participants.
ABBV-552 is not approved; it is an investigational small molecule still in clinical development. Its only recorded trial, the Phase 2 study NCT05771428 in mild Alzheimer's disease, has been completed. No regulatory approval has been granted for ABBV-552 in Alzheimer's disease or any other indication.