Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-552 · 3 trials · 3 indications
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.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Cmax of ABBV-552 will be assessed.
Tmax of ABBV-552 will be assessed.
Terminal phase elimination rate constant (λz) of ABBV-552 will be assessed.
Terminal phase elimination half-life (t1/2) of ABBV-552 will be assessed.
AUCt of ABBV-552 will be assessed.
AUCinf of ABBV-552 will be assessed.
Amount of ABBV-552 excreted in the urine over the sampling period (Aeu) will be assessed.
Percent excreted = 100 × (Aeu/dose).
Renal clearance of ABBV-552 will be assessed.
Amount of ABBV-552 excreted in the feces over the sampling period (Aef) will be assessed.
Percent excreted = 100 × (Aef/dose).
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Maximum observed plasma concentration (Cmax) of ABBV-552.
The time to Cmax (Tmax) of ABBV-552.
AUCt of ABBV-552.
AUCinf of ABBV-552.
Apparent oral clearance (CL/F) of ABBV-552.
Apparent volume of distribution (Vz/F) of ABBV-552.
Dose-normalized Cmax of ABBV-552.
AUC of ABBV-552.
| 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. |
| ABBV-552 | EXPERIMENTAL | Participants will receive ABBV-552 on Day 1. |
| Arm 1: Healthy Japanese Participants | EXPERIMENTAL | Participants will receive ABBV-552 once a week for 21 Days. |
| Arm 2: Healthy Han Chinese Participants | EXPERIMENTAL | Participants will receive ABBV-552 once a week for 7 Days. |
| 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 small molecule being studied for the treatment of mild Alzheimer's Disease (AD). It is being developed by AbbVie Inc. (ABBV) and has completed a Phase 2 clinical trial in participants aged 50 to 90 years with mild Alzheimer's Disease.
ABBV-552 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. AbbVie is conducting clinical trials to evaluate the safety and efficacy of this investigational small molecule for Alzheimer's Disease.
ABBV-552 is in Phase 2 clinical development for Alzheimer's Disease. A Phase 2 study (NCT05771428) has been completed, evaluating the drug in 263 participants with mild Alzheimer's Disease. The drug is investigational and not yet approved by regulatory authorities.
ABBV-552 has been studied in three completed clinical trials: NCT05686980, a Phase 1 study in healthy adult Japanese and Han Chinese participants; NCT05771428, a Phase 2 study in participants with mild Alzheimer's Disease; and NCT06278766, a Phase 1 mass balance study in healthy male participants.
ABBV-552 is the primary name for this investigational drug. No alternative names have been disclosed in the clinical trial records. It is identified by its compound code ABBV-552 in all registered studies.