| Characteristic | Placebo N = 861 |
Xanomeline Low Dose N = 841 |
Xanomeline High Dose N = 841 |
Overall N = 2541 |
|---|---|---|---|---|
| Age (years) | 75.2 (8.6); 76.0 [52.0, 89.0] | 75.7 (8.3); 77.5 [51.0, 88.0] | 74.4 (7.9); 76.0 [56.0, 88.0] | 75.1 (8.2); 77.0 [51.0, 89.0] |
| Age group (years) | ||||
| 18-64 | 14 (16%) | 8 (9.5%) | 11 (13%) | 33 (13%) |
| >64 | 72 (84%) | 76 (90%) | 73 (87%) | 221 (87%) |
| Sex | ||||
| Female | 53 (62%) | 50 (60%) | 40 (48%) | 143 (56%) |
| Male | 33 (38%) | 34 (40%) | 44 (52%) | 111 (44%) |
| Race | ||||
| AMERICAN INDIAN OR ALASKA NATIVE | 0 (0%) | 0 (0%) | 1 (1.2%) | 1 (0.4%) |
| BLACK OR AFRICAN AMERICAN | 8 (9.3%) | 6 (7.1%) | 9 (11%) | 23 (9.1%) |
| WHITE | 78 (91%) | 78 (93%) | 74 (88%) | 230 (91%) |
| Ethnicity | ||||
| HISPANIC OR LATINO | 3 (3.5%) | 6 (7.1%) | 3 (3.6%) | 12 (4.7%) |
| NOT HISPANIC OR LATINO | 83 (97%) | 78 (93%) | 81 (96%) | 242 (95%) |
| Treatment duration (days) | 149.5 (60.4); 182.0 [7.0, 210.0] | 97.3 (68.3); 81.0 [2.0, 212.0] | 98.2 (70.8); 76.0 [1.0, 200.0] | 115.2 (70.7); 132.0 [1.0, 212.0] |
| 1 Mean (SD); Median [Min, Max]; n (%) | ||||
| Continuous variables are summarised as mean (standard deviation); median [minimum, maximum]. | ||||
6 Demographic and baseline characteristics
The treatment groups were comparable at baseline. The mean age was 75.1 years and 143 subjects (56.3%) were female, with no clinically relevant imbalance between groups in age, sex, race or ethnicity.
6.1 Medical history
| Body system / preferred term | Placebo N = 861 |
Xanomeline Low Dose N = 841 |
Xanomeline High Dose N = 841 |
|---|---|---|---|
| Any medical history finding | 80 (93%) | 80 (95%) | 83 (99%) |
| Cardiac disorders | 17 (20%) | 23 (27%) | 17 (20%) |
| Myocardial infarction | 7 (8.1%) | 10 (12%) | 5 (6.0%) |
| Ear and labyrinth disorders | 16 (19%) | 12 (14%) | 22 (26%) |
| Deafness | 4 (4.7%) | 4 (4.8%) | 6 (7.1%) |
| Deafness bilateral | 0 (0%) | 1 (1.2%) | 5 (6.0%) |
| Hypoacusis | 5 (5.8%) | 3 (3.6%) | 4 (4.8%) |
| Tinnitus | 1 (1.2%) | 5 (6.0%) | 4 (4.8%) |
| Endocrine disorders | 7 (8.1%) | 10 (12%) | 8 (9.5%) |
| Hypothyroidism | 6 (7.0%) | 8 (9.5%) | 7 (8.3%) |
| Eye disorders | 26 (30%) | 26 (31%) | 28 (33%) |
| Cataract | 6 (7.0%) | 8 (9.5%) | 4 (4.8%) |
| Glaucoma | 7 (8.1%) | 6 (7.1%) | 6 (7.1%) |
| Hypermetropia | 2 (2.3%) | 3 (3.6%) | 6 (7.1%) |
| Macular degeneration | 5 (5.8%) | 1 (1.2%) | 2 (2.4%) |
| Gastrointestinal disorders | 29 (34%) | 29 (35%) | 28 (33%) |
| Constipation | 6 (7.0%) | 6 (7.1%) | 8 (9.5%) |
| Dyspepsia | 10 (12%) | 2 (2.4%) | 5 (6.0%) |
| General disorders and administration site conditions | 10 (12%) | 12 (14%) | 7 (8.3%) |
| Chest pain | 0 (0%) | 0 (0%) | 5 (6.0%) |
| Oedema peripheral | 7 (8.1%) | 7 (8.3%) | 1 (1.2%) |
| Infections and infestations | 16 (19%) | 15 (18%) | 14 (17%) |
| Pneumonia | 7 (8.1%) | 1 (1.2%) | 2 (2.4%) |
| Sinusitis | 5 (5.8%) | 4 (4.8%) | 3 (3.6%) |
| Investigations | 7 (8.1%) | 12 (14%) | 20 (24%) |
| Cardiac murmur | 3 (3.5%) | 3 (3.6%) | 7 (8.3%) |
| Metabolism and nutrition disorders | 12 (14%) | 8 (9.5%) | 16 (19%) |
| Diabetes mellitus | 1 (1.2%) | 1 (1.2%) | 7 (8.3%) |
| Hypercholesterolaemia | 7 (8.1%) | 4 (4.8%) | 5 (6.0%) |
| Musculoskeletal and connective tissue disorders | 37 (43%) | 41 (49%) | 40 (48%) |
| Arthritis | 14 (16%) | 19 (23%) | 14 (17%) |
| Osteoarthritis | 7 (8.1%) | 7 (8.3%) | 6 (7.1%) |
| Polyarthritis | 3 (3.5%) | 5 (6.0%) | 5 (6.0%) |
| Nervous system disorders | 20 (23%) | 17 (20%) | 24 (29%) |
| Dizziness | 3 (3.5%) | 5 (6.0%) | 8 (9.5%) |
| Headache | 9 (10%) | 9 (11%) | 11 (13%) |
| Reproductive system and breast disorders | 7 (8.1%) | 10 (12%) | 8 (9.5%) |
| Benign prostatic hyperplasia | 5 (5.8%) | 6 (7.1%) | 7 (8.3%) |
| Surgical and medical procedures | 45 (52%) | 59 (70%) | 55 (65%) |
| Appendicectomy | 8 (9.3%) | 4 (4.8%) | 11 (13%) |
| Cataract operation | 10 (12%) | 6 (7.1%) | 4 (4.8%) |
| Haemorrhoid operation | 0 (0%) | 2 (2.4%) | 5 (6.0%) |
| Hernia repair | 5 (5.8%) | 3 (3.6%) | 7 (8.3%) |
| Hysterectomy | 9 (10%) | 13 (15%) | 12 (14%) |
| Tonsillectomy | 7 (8.1%) | 8 (9.5%) | 6 (7.1%) |
| Transurethral prostatectomy | 1 (1.2%) | 5 (6.0%) | 3 (3.6%) |
| Vascular disorders | 22 (26%) | 20 (24%) | 27 (32%) |
| Hypertension | 21 (24%) | 16 (19%) | 25 (30%) |
| 1 n (%) | |||
| Subjects reporting more than one condition within a body system or preferred term are counted once. Percentages use the number of randomised subjects in each treatment group as denominator. The primary diagnosis of Alzheimer’s disease is recorded for every subject and is excluded, since it is the indication rather than a medical history finding. The overall row and the rows for each class count every subject with a qualifying record, including subjects whose only terms fall below the reporting threshold and are therefore not shown. | |||
Reported medical history was consistent with an elderly population and was distributed similarly across the treatment groups.