Table 1.
Patient Characteristics at baseline by treatment assignment.
| Characteristics | Lithium (n=38) |
Placebo (n=39) |
|---|---|---|
| Age, mean (SD), years | 75.6 (8.3) | 74.3 (6.9) |
| Women, No. (%) | 23 (60.5) | 23 (59) |
| Race/Ethnicity, No. (%) | ||
| White, non-Hispanic | 30 (78.9) | 32 (82.1) |
| African American, non-Hispanic | 4 (10.5) | 3 (7.7) |
| Hispanic/Latino | 3 (7.9) | 2 (5.1) |
| Asian | 1 (2.6) | 2 (5.1) |
| Married, No. (%) | 24 (63.2) | 28 (71.8) |
| Spouse informant, No. (%) | 24 (63.2) | 28 (71.8) |
| Education, mean (SD), years | 13.3 (4.8) | 12.8 (3.8) |
| Agitation without psychosis, No. (%) | 16 (42.1) | 18 (46.2) |
| Agitation with psychosis, No. (%) | 22 (57.9) | 21 (53.8) |
| CGI severity for behavior, mean (SD) | 4.5 (1.0) | 4.7 (1.0) |
| CGI severity global, mean (SD) | 4.5 (0.8) | 4.6 (0.8) |
| NPI total score, mean (SD) | 44.9 (21.1) | 41.8 (18.6) |
| NPI agitation/aggression, mean (SD) | 7.7 (3.1) | 7.8 (2.9) |
| NPI delusions, mean (SD) | 5.5 (4.5) | 4.8 (4.6) |
| NPI hallucinations, mean (SD) | 1.9 (3.5) | 2.6 (4.1) |
| Young Mania Rating Scale (YMRS), mean (SD) | 10.6 (8.1) | 9.1 (5.5) |
| Mini Mental State Exam (MMSE), mean (SD) | 14.3 (5.9) | 14.5 (5.8) |
| Severe Impairment Battery (SIB), mean (SD) | 79.9 (16.3) | 79.1 (18.8) |
| Basic Activities of Daily Living (BADL), mean (SD) | 4.6 (1.7) | 4.4 (1.7) |
| Zarit Caregiver burden, mean (SD) | 38.2 (16.4) | 40.2 (13.7) |
| Concomitant medications, No. (%) | ||
| Cholinesterase inhibitors | 23 (60.5) | 29 (74.4) |
| Memantine | 17 (44.7) | 21 (53.8) |
| Antipsychotics | 14 (36.8) | 21 (53.8) |
| Antidepressants | 24 (63.2) | 25 (64.1) |
| Lorazepam, No. (%) | 1 (2.6) | 6 (15.4) |
| Cumulative Illness Rating Scale-Geriatric (mean (SD)) | 4.3 (3.3) | 4.0 (2.5) |
| Treatment Emergent Symptom Scale (mean (SD)) | 5.7 (5.9) | 5.5 (5.4) |
| Simpson-Angus scale, mean (SD) | 2.4 (2.5) | 2.7 (3.4) |
| Get up & go time seconds, mean (SD) | 18.6 (18.8) | 17.3 (15.0) |
| Creatinine, mg/dl, mean (SD) | 0.9 (0.2) | 0.9 (0.2) |
| eGFR, ml/min/1.73m2, mean (SD), >60 counts as 60 | 58.9 (2.9) | 58.2 (3.6) |
| Thyroid disease, No. (%) | 10 (26.3) | 5 (12.8) |
| Apolipoprotein E ε4 positive, n (%)* | 22 (61.1) | 24 (61.5) |
CGI: Clinical Global Impression: range 1–7 (higher scores indicate greater severity). NPI: Neuropsychiatric Inventory: range 0–144 (higher score indicates greater symptoms). NPI domain (agitation/aggression, delusions, hallucinations): range 0–12 (higher scores indicate greater symptoms). Young Mania Rating Scale: range 0–60 (higher scores indicate greater symptoms). Mini Mental State Exam: range 0–30 (higher scores indicate better cognition). Severe Impairment Battery: range 0–100 (higher scores indicate better cognition). Basic Activities of Daily Living: range 0–6 (higher scores indicate better functioning). Zarit Caregiver Burden Interview: range 0–88 (higher scores indicate greater burden). CIRS-G: Cumulative Illness Rating Scale-Geriatric: range 0–48 (higher scores indicate more medical illnesses). Treatment Emergent Symptom Scale: range 0–26 (higher scores indicate more somatic symptoms). Simpson Angus Scale for Extrapyramidal Signs: range 0–40 (higher scores indicate increased severity of signs). eGFR: estimated Glomerular Filtration Rate: range 0–60 (higher scores indicate better kidney function).
2 participants in the lithium group had missing values.