Trial Outcomes & Findings for 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 (NCT NCT05771428)

Last Updated: 2025-10-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

263 participants

Primary outcome timeframe

Week 12

Results posted on

2025-10-15

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo for ABBV-552 once daily (QD) for 12 weeks.	ABBV-552: 1 mg Participants received 1 mg of ABBV-552 QD for 12 weeks.	ABBV-552: 5 mg Participants received 5 mg of ABBV-552 QD for 12 weeks.	ABBV-552: 15 mg Participants received 5 mg of ABBV-552 QD for 12 weeks.
Overall Study STARTED	66	65	66	66
Overall Study mITT Population	65	63	64	63
Overall Study COMPLETED	63	61	61	60
Overall Study NOT COMPLETED	3	4	5	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo for ABBV-552 once daily (QD) for 12 weeks.	ABBV-552: 1 mg Participants received 1 mg of ABBV-552 QD for 12 weeks.	ABBV-552: 5 mg Participants received 5 mg of ABBV-552 QD for 12 weeks.	ABBV-552: 15 mg Participants received 5 mg of ABBV-552 QD for 12 weeks.
Overall Study Adverse Event	0	1	1	1
Overall Study Withdrawal by Subject	3	2	1	4
Overall Study Other	0	1	2	1
Overall Study Randomized but Not Treated	0	0	1	0

Baseline Characteristics

Includes mITT participants with data available for analysis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=66 Participants Participants received placebo for ABBV-552 once daily (QD) for 12 weeks.	ABBV-552: 1 mg n=65 Participants Participants received 1 mg of ABBV-552 QD for 12 weeks.	ABBV-552: 5 mg n=65 Participants Participants received 5 mg of ABBV-552 QD for 12 weeks.	ABBV-552: 15 mg n=66 Participants Participants received 5 mg of ABBV-552 QD for 12 weeks.	Total n=262 Participants Total of all reporting groups
Age, Continuous	72.7 years STANDARD_DEVIATION 9.19 • n=66 Participants	73.5 years STANDARD_DEVIATION 7.33 • n=65 Participants	73.2 years STANDARD_DEVIATION 7.78 • n=65 Participants	73.1 years STANDARD_DEVIATION 7.60 • n=66 Participants	73.1 years STANDARD_DEVIATION 7.97 • n=262 Participants
Sex: Female, Male Female	30 Participants n=66 Participants	40 Participants n=65 Participants	43 Participants n=65 Participants	33 Participants n=66 Participants	146 Participants n=262 Participants
Sex: Female, Male Male	36 Participants n=66 Participants	25 Participants n=65 Participants	22 Participants n=65 Participants	33 Participants n=66 Participants	116 Participants n=262 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=66 Participants	25 Participants n=65 Participants	27 Participants n=65 Participants	22 Participants n=66 Participants	94 Participants n=262 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=66 Participants	40 Participants n=65 Participants	38 Participants n=65 Participants	44 Participants n=66 Participants	168 Participants n=262 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=66 Participants	0 Participants n=65 Participants	0 Participants n=65 Participants	0 Participants n=66 Participants	0 Participants n=262 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=66 Participants	1 Participants n=65 Participants	0 Participants n=65 Participants	0 Participants n=66 Participants	1 Participants n=262 Participants
Race (NIH/OMB) Asian	6 Participants n=66 Participants	3 Participants n=65 Participants	7 Participants n=65 Participants	10 Participants n=66 Participants	26 Participants n=262 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=66 Participants	0 Participants n=65 Participants	0 Participants n=65 Participants	0 Participants n=66 Participants	0 Participants n=262 Participants
Race (NIH/OMB) Black or African American	8 Participants n=66 Participants	5 Participants n=65 Participants	7 Participants n=65 Participants	7 Participants n=66 Participants	27 Participants n=262 Participants
Race (NIH/OMB) White	52 Participants n=66 Participants	55 Participants n=65 Participants	51 Participants n=65 Participants	47 Participants n=66 Participants	205 Participants n=262 Participants
Race (NIH/OMB) More than one race	0 Participants n=66 Participants	0 Participants n=65 Participants	0 Participants n=65 Participants	1 Participants n=66 Participants	1 Participants n=262 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=66 Participants	1 Participants n=65 Participants	0 Participants n=65 Participants	1 Participants n=66 Participants	2 Participants n=262 Participants
ADAS-Cog 14 Score at Baseline	24.10 units on a scale STANDARD_DEVIATION 8.260 • n=64 Participants • Includes mITT participants with data available for analysis.	22.99 units on a scale STANDARD_DEVIATION 8.573 • n=63 Participants • Includes mITT participants with data available for analysis.	23.24 units on a scale STANDARD_DEVIATION 7.780 • n=64 Participants • Includes mITT participants with data available for analysis.	23.82 units on a scale STANDARD_DEVIATION 8.273 • n=63 Participants • Includes mITT participants with data available for analysis.	23.54 units on a scale STANDARD_DEVIATION 8.188 • n=254 Participants • Includes mITT participants with data available for analysis.

PRIMARY outcome

Timeframe: Week 12

Population: mITT population includes participants who received at least 1 dose of study drug, have at least 1 post baseline assessment of ADAS-Cog 14, and have data available for analysis.

Outcome measures

Outcome measures
Measure	Placebo n=58 Participants Participants received placebo for ABBV-552 once daily (QD) for 12 weeks.	ABBV-552: 1 mg n=56 Participants Participants received 1 mg of ABBV-552 QD for 12 weeks.	ABBV-552: 5 mg n=58 Participants Participants received 5 mg of ABBV-552 QD for 12 weeks.	ABBV-552: 15 mg n=59 Participants Participants received 5 mg of ABBV-552 QD for 12 weeks.
Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 14) Score at Week 12	-1.26 score on a scale Standard Error 0.660	-1.28 score on a scale Standard Error 0.668	-1.68 score on a scale Standard Error 0.658	-1.01 score on a scale Standard Error 0.655

Adverse Events

Placebo

Serious events: 3 serious events

Other events: 15 other events

Deaths: 0 deaths

ABBV-552: 1 mg

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

ABBV-552: 5 mg

Serious events: 2 serious events

Other events: 19 other events

Deaths: 1 deaths

ABBV-552: 15 mg

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=66 participants at risk Participants received placebo for ABBV-552 once daily (QD) for 12 weeks.	ABBV-552: 1 mg n=65 participants at risk Participants received 1 mg of ABBV-552 QD for 12 weeks.	ABBV-552: 5 mg n=66 participants at risk Participants received 5 mg of ABBV-552 QD for 12 weeks.	ABBV-552: 15 mg n=66 participants at risk Participants received 15 mg of ABBV-552 QD for 12 weeks.
Cardiac disorders ANGINA PECTORIS	0.00% 0/66 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	1.5% 1/65 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	0.00% 0/66 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	0.00% 0/66 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.
Cardiac disorders ATRIAL FIBRILLATION	0.00% 0/66 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	1.5% 1/65 • Number of events 2 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	0.00% 0/66 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	0.00% 0/66 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.
Congenital, familial and genetic disorders BRUGADA SYNDROME	1.5% 1/66 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	0.00% 0/65 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	0.00% 0/66 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	0.00% 0/66 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.
Ear and labyrinth disorders VERTIGO POSITIONAL	0.00% 0/66 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	0.00% 0/65 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	0.00% 0/66 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	1.5% 1/66 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.
Gastrointestinal disorders LOWER GASTROINTESTINAL HAEMORRHAGE	0.00% 0/66 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	0.00% 0/65 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	1.5% 1/66 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	0.00% 0/66 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.
General disorders PYREXIA	0.00% 0/66 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	0.00% 0/65 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	0.00% 0/66 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	1.5% 1/66 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.
Injury, poisoning and procedural complications ROAD TRAFFIC ACCIDENT	0.00% 0/66 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	0.00% 0/65 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	1.5% 1/66 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	0.00% 0/66 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.
Musculoskeletal and connective tissue disorders ARTHRALGIA	1.5% 1/66 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	0.00% 0/65 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	0.00% 0/66 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	0.00% 0/66 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.
Musculoskeletal and connective tissue disorders RHABDOMYOLYSIS	1.5% 1/66 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	0.00% 0/65 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	0.00% 0/66 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	0.00% 0/66 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.
Nervous system disorders ISCHAEMIC STROKE	0.00% 0/66 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	1.5% 1/65 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	0.00% 0/66 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	0.00% 0/66 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.

Other adverse events

Other adverse events
Measure	Placebo n=66 participants at risk Participants received placebo for ABBV-552 once daily (QD) for 12 weeks.	ABBV-552: 1 mg n=65 participants at risk Participants received 1 mg of ABBV-552 QD for 12 weeks.	ABBV-552: 5 mg n=66 participants at risk Participants received 5 mg of ABBV-552 QD for 12 weeks.	ABBV-552: 15 mg n=66 participants at risk Participants received 15 mg of ABBV-552 QD for 12 weeks.
Gastrointestinal disorders DIARRHOEA	0.00% 0/66 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	1.5% 1/65 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	7.6% 5/66 • Number of events 5 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	3.0% 2/66 • Number of events 2 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.
General disorders FATIGUE	3.0% 2/66 • Number of events 2 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	4.6% 3/65 • Number of events 4 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	3.0% 2/66 • Number of events 3 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	10.6% 7/66 • Number of events 7 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.
Infections and infestations NASOPHARYNGITIS	3.0% 2/66 • Number of events 3 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	3.1% 2/65 • Number of events 2 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	1.5% 1/66 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	6.1% 4/66 • Number of events 4 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	1.5% 1/66 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	6.2% 4/65 • Number of events 5 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	3.0% 2/66 • Number of events 2 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	4.5% 3/66 • Number of events 4 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.
Infections and infestations URINARY TRACT INFECTION	4.5% 3/66 • Number of events 3 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	9.2% 6/65 • Number of events 6 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	0.00% 0/66 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	0.00% 0/66 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.
Injury, poisoning and procedural complications FALL	7.6% 5/66 • Number of events 7 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	3.1% 2/65 • Number of events 2 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	3.0% 2/66 • Number of events 2 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	3.0% 2/66 • Number of events 2 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.
Nervous system disorders DIZZINESS	4.5% 3/66 • Number of events 3 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	3.1% 2/65 • Number of events 2 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	6.1% 4/66 • Number of events 4 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	12.1% 8/66 • Number of events 8 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.
Nervous system disorders HEADACHE	3.0% 2/66 • Number of events 2 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	3.1% 2/65 • Number of events 2 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	6.1% 4/66 • Number of events 4 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	3.0% 2/66 • Number of events 2 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.
Nervous system disorders SOMNOLENCE	0.00% 0/66 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	0.00% 0/65 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	6.1% 4/66 • Number of events 4 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.	1.5% 1/66 • Number of events 2 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.

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