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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05771428 | Study to Assess Adverse Events, Change in Disease Activity and How Oral ABBV-552 Capsules Moves Through the Body of Participants Aged 50 to 90 Years With Mild Alzheimer's Disease | PHASE2 | COMPLETED | 263 | — | — | Jun 5, 2023 | Sep 12, 2024 | Oct 15, 2025 | 64 | United States, Australia +5 |
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...