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Table 1 Patient demographics and baseline characteristics (pooled analysis)

From: Evaluation of the efficacy, safety and tolerability of orally administered BI 409306, a novel phosphodiesterase type 9 inhibitor, in two randomised controlled phase II studies in patients with prodromal and mild Alzheimer’s disease

  BI 409306
10 mg QD
(n = 77)
BI 409306
25 mg QD
(n = 74)
BI 409306
50 mg QD
(n = 76)
BI 409306
25 mg BID
(n = 76)
Placebo
(n = 149)
Male, n (%) 41 (53.2) 32 (43.2) 42 (55.3) 33 (43.4) 73 (49.0)
Age (years), mean (SD) 73.3 (7.7) 74.2 (7.8) 73.1 (6.1) 74.0 (8.4) 73.5 (7.4)
Race, n (%)
 Asian 1 (1.3) 0 (0) 1 (1.3) 0 (0) 0 (0)
 Black or African American 0 (0) 0 (0) 0 (0) 0 (0) 3 (2.0)
 White 76 (98.7) 74 (100.0) 75 (98.7) 76 (100.0) 146 (98.0)
Body mass index, (kg/m2), mean (SD) 26.0 (3.4) 27.2 (5.2) 26.7 (3.7) 25.5 (3.9) 26.2 (4.1)
Smoking status, n (%)
 Never smoked 38 (49.4) 47 (63.5) 43 (56.6) 44 (57.9) 79 (53.0)
 Ex-smoker 30 (39.0) 24 (32.4) 30 (39.5) 25 (32.9) 61 (40.9)
 Current smoker 9 (11.7) 3 (4.1) 3 (3.9) 7 (9.2) 9 (6.0)
Alcohol status, n (%)
 Non-drinker 36 (46.8) 30 (40.5) 29 (38.2) 37 (48.7) 72 (48.3)
 Drinks—no interference 41 (53.2) 44 (59.5) 47 (61.8) 39 (51.3) 77 (51.7)
 Drinks—possible interference 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)
ApoE e4-positive, n (%)
 e3/e4 29 (37.7) 25 (33.8) 32 (42.1) 22 (28.9) 62 (41.6)
 e4/e4 5 (6.5) 8 (10.8) 7 (9.2) 11 (14.5) 15 (10.1)
NTB total
n 71 67 73 67 134
 Mean (SD) 0.05 (0.66) − 0.12 (0.61) 0.01 (0.67) 0.05 (0.65) − 0.03 (0.66)
 Median (range) 0.01 (−1.7–1.8) − 0.09 (− 1.6–1.6) − 0.03 (− 1.2–1.7) 0.12 (− 1.5–1.9) 0.05 (− 1.7–2.1)
ADAS-Cog11 total
n 70 66 69 69 129
 Mean (SD) 16.90 (7.79) 19.23 (7.70) 17.45 (8.05) 19.43 (8.7) 18.52 (8.31)
 Median (range) 16.33 (2.3–41.0) 19.00 (4.0–38.0) 15.67 (3.0–39.7) 17.33 (6.0–49.7) 17.00 (2.7–41.7)
CDR-SB total
n 75 73 76 74 148
 Mean (SD) 4.75 (2.13) 4.76 (2.23) 4.70 (2.17) 5.18 (2.78) 4.91 (2.43)
 Median (range) 4.50 (0.5–12.0) 4.50 (1.0–10.0) 4.50 (0.5–10.0) 5.00 (0.5–14.0) 4.50 (0.5–14.0)
  1. ADAS-Cog11 Alzheimer’s Disease Assessment Scale-cognitive subscale, ApoE e4 apolipoprotein E e4 allele, BID twice daily, CDR-SB Clinical Dementia Rating scale-Sum of Boxes, NTB Neuropsychological Test Battery, QD once daily, SD standard deviation