From: Long-term treatment with active Aβ immunotherapy with CAD106 in mild Alzheimer’s disease
Core studies | Extension studies | |||||
---|---|---|---|---|---|---|
CAD106 (2201) | CAD106 (2202) | CAD106 (pooled) | Placebo (pooled) | CAD106 total (pooled) | ||
N = 22 (all s.c.) | N = 25 (n = 9 s.c.; n = 16 i.m.) | N = 47 | N = 11 | N = 45 | ||
Deaths | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (2.2) | |
SAEs | 4 (18.2) | 5 (20.0) | 9 (19.1) | 4 (36.4) | 6 (13.3) | |
Intracerebral hemorrhage | 1 (4.5)** | 0 (0.0) | 1 (2.1) | 0 (0.0) | 0 (0.0) | |
Discontinuations due to (S)AEs | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (4.4) | |
Amyloid-related imaging abnormalities* | 1 (4.5) | 0 (0.0) | 1 (2.1) | 1 (9.1) | 2 (4.4) | |
With hemorrhage | 1 (4.5)** | 0 (0.0) | 1 (2.1) | 1 (9.1) | 2 (4.4) | |
Any primary system organ class, n (%) | 15 (68.2) | 20 (80.0) | 35 (74.5) | 7 (63.6) | 37 (82.2) | |
Cardiac disorders | 3 (13.6) | 3 (12.0) | 6 (12.8) | 0 (0.0) | 7 (15.6) | |
Gastrointestinal disorders | 6 (27.3) | 2 (8.0) | 8 (17.0) | 2 (18.2) | 15 (33.3) | |
Diarrhea | 3 (13.6) | 0 (0.0) | 3 (6.4) | 0 (0.0) | 6 (13.3) | |
General disorders and administration site conditions | 6 (27.3) | 8 (32.0) | 14 (29.8) | 2 (18.2) | 9 (20.0) | |
Pyrexia | 1 (4.5) | 3 (12.0) | 4 (8.5) | 1 (9.1) | 0 (0.0) | |
Fatigue | 1 (4.5) | 2 (8.0) | 3 (6.4) | 1 (9.1) | 6 (13.3) | |
Infections and infestations | 8 (36.4) | 3 (12.0) | 11 (23.4) | 3 (27.3) | 16 (35.6) | |
Nasopharyngitis | 2 (9.1) | 0 (0.0) | 2 (4.3) | 0 (0.0) | 6 (13.3) | |
Injury, poisoning and procedural complications | 0 (0.0) | 5 (20.0) | 5 (10.6) | 2 (18.2) | 9 (20.0) | |
Fall | 0 (0.0) | 3 (12.0) | 3 (6.4) | 1 (9.1) | 3 (6.7) | |
Investigations | 4 (18.2) | 2 (8.0) | 6 (12.8) | 2 (18.2) | 4 (8.9) | |
Musculoskeletal and connective tissue disorders | 6 (27.3) | 3 (12.0) | 9 (19.1) | 1 (9.1) | 9 (20.0) | |
Back pain | 1 (4.5) | 3 (12.0) | 4 (8.5) | 0 (0.0) | 3 (6.7) | |
Nervous system disorders | 4 (18.2) | 6 (24.0) | 10 (21.3) | 2 (18.2) | 11 (24.4) | |
Headache | 2 (9.1) | 4 (16.0) | 6 (12.8) | 0 (0.0) | 6 (13.3) | |
Psychiatric disorders | 2 (9.1) | 6 (24.0) | 8 (17.0) | 4 (36.4) | 15 (33.3) | |
Confusional state | 0 (0.0) | 3 (12.0) | 3 (6.4) | 0 (0.0) | 3 (6.7) | |
Depression | 1 (4.5) | 2 (8.0) | 3 (6.4) | 0 (0.0) | 6 (13.3) | |
Renal and urinary disorders | 2 (9.1) | 4 (16.0) | 6 (12.8) | 1 (9.1) | 4 (8.9) | |
Skin and subcutaneous tissue disorders | 0 (0.0) | 6 (24.0) | 6 (12.8) | 1 (9.1) | 7 (15.6) |