Adults 55 to 85, any sex, with Alzheimer's Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline Over Time in CDR-SB ScorePrimary· Baseline, Week 24, Week 48, Week 72, Week 96
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.
Change to Week 24
Group
Value
95% CI
Placebo
0.60
± 0.125
ABBV-8E12 300 mg
0.66
± 0.129
ABBV-8E12 1000 mg
0.44
± 0.125
ABBV-8E12 2000 mg
0.63
± 0.130
Change to Week 48
Group
Value
95% CI
Placebo
1.06
± 0.155
ABBV-8E12 300 mg
1.15
± 0.161
ABBV-8E12 1000 mg
1.05
± 0.154
ABBV-8E12 2000 mg
0.99
± 0.161
Change to Week 72
Group
Value
95% CI
Placebo
1.90
± 0.213
ABBV-8E12 300 mg
1.88
± 0.220
ABBV-8E12 1000 mg
1.85
± 0.212
ABBV-8E12 2000 mg
1.81
± 0.219
Change to Week 96
Group
Value
95% CI
Placebo
2.54
± 0.271
ABBV-8E12 300 mg
2.47
± 0.277
ABBV-8E12 1000 mg
2.48
± 0.267
ABBV-8E12 2000 mg
2.70
± 0.279
Number of Participants With Treatment Emergent Adverse Events (TEAEs)Primary· From first dose of study drug up to last dose of study drug plus 20 weeks (up to Week 112)
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
Any TEAE
Group
Value
95% CI
Placebo
108
ABBV-8E12 300 mg
94
ABBV-8E12 1000 mg
108
ABBV-8E12 2000 mg
104
Severe TEAE
Group
Value
95% CI
Placebo
12
ABBV-8E12 300 mg
13
ABBV-8E12 1000 mg
14
ABBV-8E12 2000 mg
11
TEAE With a Reasonable Possibility to Study Drug
Group
Value
95% CI
Placebo
28
ABBV-8E12 300 mg
32
ABBV-8E12 1000 mg
31
ABBV-8E12 2000 mg
33
SAE
Group
Value
95% CI
Placebo
26
ABBV-8E12 300 mg
19
ABBV-8E12 1000 mg
22
ABBV-8E12 2000 mg
17
TEAE Leading to Discontinuation of Study Drug
Group
Value
95% CI
Placebo
4
ABBV-8E12 300 mg
6
ABBV-8E12 1000 mg
6
ABBV-8E12 2000 mg
4
Fatal TEAE
Group
Value
95% CI
Placebo
1
ABBV-8E12 300 mg
2
ABBV-8E12 1000 mg
2
ABBV-8E12 2000 mg
1
All Deaths
Group
Value
95% CI
Placebo
1
ABBV-8E12 300 mg
2
ABBV-8E12 1000 mg
2
ABBV-8E12 2000 mg
1
Maximum Observed Serum Concentration (Cmax) for ABBV-8E12 Over the Dosing Interval After the First and Fourth DosesSecondary· Day 1 (Dose 1): Pre-infusion, post-infusion (within 15 minutes), 1 and 2 hours post-infusion; Days 5 and 15. Day 85 (Dose 4): Pre-infusion (0 hour), post-infusion (within 15 minutes) and 1 and 2 hours post-infusion; Days 89 and 99.
First Dosing Interval
Group
Value
95% CI
ABBV-8E12 300 mg
108
± 28
ABBV-8E12 1000 mg
284
± 21
ABBV-8E12 2000 mg
528
± 27
Fourth Dosing Interval
Group
Value
95% CI
ABBV-8E12 300 mg
168
± 23
ABBV-8E12 1000 mg
426
± 20
ABBV-8E12 2000 mg
806
± 37
Time to Cmax (Tmax) for ABBV-8E12 Over the Dosing Interval After the First and Fourth DosesSecondary· Day 1 (Dose 1): Pre-infusion, post-infusion (within 15 minutes), 1 and 2 hours post-infusion; Days 5 and 15. Day 85 (Dose 4): Pre-infusion (0 hour), post-infusion (within 15 minutes) and 1 and 2 hours post-infusion; Days 89 and 99.
First Dosing Interval
Group
Value
95% CI
ABBV-8E12 300 mg
3
1.8 – 4.2
ABBV-8E12 1000 mg
2.5
1.3 – 4.2
ABBV-8E12 2000 mg
2.7
1.7 – 3.6
Fourth Dosing Interval
Group
Value
95% CI
ABBV-8E12 300 mg
2.4
1.1 – 4.1
ABBV-8E12 1000 mg
2.5
1.7 – 4.3
ABBV-8E12 2000 mg
2.3
1.7 – 3.6
Serum Concentration at the End of a Dose Interval (Ctrough) for ABBV-8E12 Over the Dosing Interval After the First and Fourth DosesSecondary· Day 1 (Dose 1): Pre-infusion, post-infusion (within 15 minutes), 1 and 2 hours post-infusion; Days 5 and 15. Day 85 (Dose 4): Pre-infusion (0 hour), post-infusion (within 15 minutes) and 1 and 2 hours post-infusion; Days 89 and 99.
First Dosing Interval
Group
Value
95% CI
ABBV-8E12 300 mg
28.6
± 22
ABBV-8E12 1000 mg
75.1
± 33
ABBV-8E12 2000 mg
163
± 26
Fourth Dosing Interval
Group
Value
95% CI
ABBV-8E12 300 mg
56.4
± 25
ABBV-8E12 1000 mg
182
± 29
ABBV-8E12 2000 mg
320
± 36
Half-Life (T1/2) for ABBV-8E12 Over the Dosing Interval After the First and Fourth DosesSecondary· Day 1 (Dose 1): Pre-infusion, post-infusion (within 15 minutes), 1 and 2 hours post-infusion; Days 5 and 15. Day 85 (Dose 4): Pre-infusion (0 hour), post-infusion (within 15 minutes) and 1 and 2 hours post-infusion; Days 89 and 99.
Harmonic mean is presented in the data table.
First Dosing Interval
Group
Value
95% CI
ABBV-8E12 300 mg
22.0
± 17.2
ABBV-8E12 1000 mg
19.4
± 8.87
ABBV-8E12 2000 mg
33.2
± 10.5
Fourth Dosing Interval
Group
Value
95% CI
ABBV-8E12 300 mg
19.6
± 6.09
ABBV-8E12 1000 mg
24.0
± 16.6
ABBV-8E12 2000 mg
37.5
± 13.5
Area Under the Concentration-Time Curve From Dosing (Time 0) to Day 28 (AUC0-28) for ABBV-8E12 Over the Dosing Interval After the First and Fourth DosesSecondary· Day 1 (Dose 1): pre-infusion, up to Day 29 (trough level before Dose 2). Day 85 (Dose 4): pre-infusion, up to Day 113 (trough level before Dose 5). See Outcome Measure description above for complete time point details.
* The AUC0-28 for Dose 1 included the following timepoints: pre-infusion, post-infusion (within 15 min), 1 and 2 hours post-infusion, Day 5, Day 15 and Day 29 (trough level before Dose 2).
* The AUC0-28 for Dose 4 included the following timepoints: Day 85 pre-infusion, post-infusion (within 15 min), 1 and 2 hours post-infusion, Day 89, Day 99 and Day 113 (trough level before Dose 5).
First Dosing Interval
Group
Value
95% CI
ABBV-8E12 300 mg
2520
± 28
ABBV-8E12 1000 mg
6090
± 37
ABBV-8E12 2000 mg
14800
± 25
Fourth Dosing Interval
Group
Value
95% CI
ABBV-8E12 300 mg
4230
± 33
ABBV-8E12 1000 mg
13100
± 36
ABBV-8E12 2000 mg
30200
± 36
Cmax/Dose for ABBV-8E12 Over the Dosing Interval After the First and Fourth DosesSecondary· Day 1 (Dose 1): Pre-infusion, post-infusion (within 15 minutes), 1 and 2 hours post-infusion; Days 5 and 15. Day 85 (Dose 4): Pre-infusion (0 hour), post-infusion (within 15 minutes) and 1 and 2 hours post-infusion; Days 89 and 99.
First Dosing Interval
Group
Value
95% CI
ABBV-8E12 300 mg
0.359
± 28
ABBV-8E12 1000 mg
0.284
± 21
ABBV-8E12 2000 mg
0.264
± 27
Fourth Dosing Interval
Group
Value
95% CI
ABBV-8E12 300 mg
0.561
± 23
ABBV-8E12 1000 mg
0.426
± 20
ABBV-8E12 2000 mg
0.403
± 37
AUC0-28/Dose for ABBV-8E12 Over the Dosing Interval After the First and Fourth DosesSecondary· Day 1 (Dose 1): pre-infusion, up to Day 29 (trough level before Dose 2). Day 85 (Dose 4): pre-infusion, up to Day 113 (trough level before Dose 5). See Outcome Measure description above for complete time point details.
* The AUC0-28/dose for Dose 1 included the following timepoints: pre-infusion, post-infusion (within 15 min), 1 and 2 hours post-infusion, Day 5, Day 15 and Day 29 (trough level before Dose 2).
* The AUC0-28/dose for Dose 4 included the following timepoints: Day 85 pre-infusion, post-infusion (within 15 min), 1 and 2 hours post-infusion, Day 89, Day 99 and Day 113 (trough level before Dose 5).
First Dosing Interval
Group
Value
95% CI
ABBV-8E12 300 mg
8.40
± 28
ABBV-8E12 1000 mg
6.09
± 37
ABBV-8E12 2000 mg
7.41
± 25
Fourth Dosing Interval
Group
Value
95% CI
ABBV-8E12 300 mg
14.1
± 33
ABBV-8E12 1000 mg
13.1
± 36
ABBV-8E12 2000 mg
15.1
± 36
Change From Baseline Over Time in Alzheimer's Disease Assessment Scale (14-Item) Cognition Portion (ADAS-Cog-14) Total ScoreSecondary· Baseline, Week 24, Week 48, Week 72, Week 96
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 increa
Change at Week 24
Group
Value
95% CI
Placebo
1.82
± 0.492
ABBV-8E12 300 mg
1.42
± 0.498
ABBV-8E12 1000 mg
0.56
± 0.480
ABBV-8E12 2000 mg
1.86
± 0.503
Change at Week 48
Group
Value
95% CI
Placebo
4.50
± 0.621
ABBV-8E12 300 mg
3.51
± 0.642
ABBV-8E12 1000 mg
3.42
± 0.605
ABBV-8E12 2000 mg
4.03
± 0.647
Change at Week 72
Group
Value
95% CI
Placebo
5.26
± 0.718
ABBV-8E12 300 mg
4.78
± 0.730
ABBV-8E12 1000 mg
5.00
± 0.706
ABBV-8E12 2000 mg
6.37
± 0.738
Change at Week 96
Group
Value
95% CI
Placebo
8.43
± 0.898
ABBV-8E12 300 mg
7.99
± 0.891
ABBV-8E12 1000 mg
7.84
± 0.872
ABBV-8E12 2000 mg
9.46
± 0.935
Change From Baseline Over Time in ADAS-Cog-14 Comprehension of Spoken Language ScoreSecondary· Baseline, Week 24, Week 48, Week 72, Week 96
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 increa
Change at Week 24
Group
Value
95% CI
Placebo
0.01
± 0.038
ABBV-8E12 300 mg
0.03
± 0.038
ABBV-8E12 1000 mg
0.04
± 0.037
ABBV-8E12 2000 mg
0.08
± 0.039
Change at Week 48
Group
Value
95% CI
Placebo
0.03
± 0.044
ABBV-8E12 300 mg
0.09
± 0.046
ABBV-8E12 1000 mg
0.07
± 0.044
ABBV-8E12 2000 mg
0.12
± 0.046
Change at Week 72
Group
Value
95% CI
Placebo
0.17
± 0.064
ABBV-8E12 300 mg
0.11
± 0.066
ABBV-8E12 1000 mg
0.14
± 0.064
ABBV-8E12 2000 mg
0.31
± 0.066
Change at Week 96
Group
Value
95% CI
Placebo
0.30
± 0.083
ABBV-8E12 300 mg
0.26
± 0.083
ABBV-8E12 1000 mg
0.19
± 0.080
ABBV-8E12 2000 mg
0.29
± 0.085
Change From Baseline Over Time in ADAS-Cog-14 Constructional Praxis ScoreSecondary· Baseline, Week 24, Week 48, Week 72, Week 96
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 increa
Change at Week 24
Group
Value
95% CI
Placebo
0.11
± 0.057
ABBV-8E12 300 mg
0.05
± 0.058
ABBV-8E12 1000 mg
-0.02
± 0.056
ABBV-8E12 2000 mg
0.09
± 0.059
Change at Week 48
Group
Value
95% CI
Placebo
0.07
± 0.073
ABBV-8E12 300 mg
0.23
± 0.077
ABBV-8E12 1000 mg
0.17
± 0.072
ABBV-8E12 2000 mg
0.20
± 0.077
Change at Week 72
Group
Value
95% CI
Placebo
0.25
± 0.069
ABBV-8E12 300 mg
0.22
± 0.072
ABBV-8E12 1000 mg
0.16
± 0.070
ABBV-8E12 2000 mg
0.16
± 0.071
Change at Week 96
Group
Value
95% CI
Placebo
0.41
± 0.089
ABBV-8E12 300 mg
0.25
± 0.089
ABBV-8E12 1000 mg
0.026
± 0.086
ABBV-8E12 2000 mg
0.33
± 0.092
Adverse events — posted to ClinicalTrials.gov
Time frame: From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie
Last refreshed: 26 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02880956.