Table 1.
Baseline demographics and clinical characteristics
| Placebo | PIM 34 mg | Total | |
| (N = 392) | (N = 392) | (N = 784) | |
| Sex (female), n (%)a | 213 (54.3) | 240 (61.2) | 453 (57.8) |
| Age, mean (SE) | 72.1 (0.36) | 72.7 (0.35) | 72.4 (0.25) |
| Age categories at screening (y), n (%)a | |||
| <65 | 64 (16.3) | 54 (13.8) | 118 (15.1) |
| 65 to 74 | 187 (47.7) | 169 (43.1) | 356 (45.4) |
| 75 to 84 | 121 (30.9) | 151 (38.5) | 272 (34.7) |
| ≥85 | 20 (5.1) | 18 (4.6) | 38 (4.8) |
| Dementia subtype, n (%) | |||
| Alzheimer’s disease | 260 (66.3) | 276 (70.4) | 536 (68.4) |
| Vascular dementia | 80 (20.4) | 71 (18.1) | 151 (19.3) |
| Parkinson’s diseaseb,c | 37 (9.4) | 35 (8.9) | 72 (9.2)d |
| Without dementia | 13 (3.3) | 16 (4.1) | 29 (3.7) |
| With dementia | 24 (6.1) | 16 (4.1) | 40 (5.1) |
| Frontotemporal dementia | 9 (2.3) | 8 (2.0) | 17 (2.2) |
| Dementia with Lewy bodies | 6 (1.5) | 5 (1.3) | 11 (1.4) |
| Race (White), n (%)a | 367 (93.6) | 368 (93.9) | 735 (93.8) |
| Ethnicity, n (%)a | |||
| Hispanic or Latino | 124 (31.6) | 120 (30.6) | 244 (31.1) |
| Not Hispanic or Latino | 268 (68.4) | 272 (69.4) | 540 (68.9) |
| Region, n (%)a | |||
| North America | 123 (31.4) | 123 (31.4) | 246 (31.4) |
| Europe | 250 (63.8) | 250 (63.8) | 500 (63.8) |
| Rest of the world | 19 (4.8) | 19 (4.8) | 38 (4.8) |
| MMSE, mean (SE) | 18.6 (0.23) | 18.4 (0.24) | 18.5 (0.17) |
| CGI-S, mean (SE) | 4.5 (0.03) | 4.6 (0.03) | 4.6 (0.02) |
| EQ-5D-5L visual analog scale, mean (SE) | 52.7 (0.92) | 54.6 (0.94) | 53.6 (0.66) |
| ESRS-A, mean (SE) | 6.1 (0.56) | 5.9 (0.53) | 6.0 (0.38) |
| SDI, mean (SE) | 1.3 (0.08) | 1.2 (0.07) | 1.2 (0.05) |
| QTcF, mean (SE) | 407.9 (0.92) | 409.5 (0.87) | – |
| Ever had suicidal ideation or behavior, assessed with C-SSRS or GCAS, yes, n (%)a | 6 (1.7) | 6 (1.6) | 12 (1.7) |
an = subjects with non-missing data in the given treatment group and was used as the denominator for calculating percentages. bThree subjects have Parkinson’s disease but do not have Parkinson’s disease as the primary cause of dementia. cIncludes Parkinson’s disease subjects with and without dementia. dThe proportions were balanced across pimavanserin and placebo. CGI-S, Clinical Global Impression-Severity; C-SSRS, Columbia-Suicide Severity Rating Scale; ESRS-A, Extrapyramidal Symptom Rating Scale-Abbreviated; EQ-5D-5L, 5-level version of EQ-5D-5L; GCAS, Global Clinician Assessment of Suicidality; MMSE, Mini-Mental State Examination; PIM, pimavanserin; QTcF, corrected QT interval using Fridericia’s correction method; SDI, Sleep Disturbances Inventory.