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Table 2 Summary of change from baseline to week 12 in primary, secondary and further endpoints from the pooled analysis (mixed-model repeated measurement)

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

Endpoints BI 409306
10 mg QD
(n = 67)
BI 409306
25 mg QD
(n = 63)
BI 409306
50 mg QD
(n = 67)
BI 409306
25 mg BID
(n = 63)
Placebo
(n = 122)
Primary endpoint
 NTB total z-score
  Adjusted mean (SE) change from baseline 0.20 (0.046) 0.19 (0.048) 0.19 (0.046) 0.10 (0.047) 0.19 (0.035)
  p value* 0.87 0.95 0.93 0.13
Secondary endpoints
 CDR-SB
  Adjusted mean (SE) change from baseline 0.1 (0.170) 0.3 (0.170) 0.1 (0.170) 0.1 (0.170) 0.0 (0.120)
  p value* 0.82 0.20 0.94 0.66  
 ADAS-Cog11
  Adjusted mean (SE) change from baseline 1.13 (0.593) 0.80 (0.623) 0.82 (0.596) 1.32 (0.596) 0.27 (0.444)
  p value* 0.25 0.49 0.46 0.16
 Study 1: ADCS-MCI-ADL
  Adjusted mean (SE) change from baseline 0.24 (0.896) 1.79 (0.921) − 0.10 (0.875) 0.80 (0.947) 0.38 (0.642)
  p value* 0.90 0.21 0.66 0.72
 Study 2: ADCS-ADL
  Adjusted mean (SE) change from baseline 0.10 (0.853) − 0.99 (0.892) 0.35 (0.847) − 1.07 (0.855) − 0.58 (0.639)
  p value* 0.53 0.71 0.38 0.65
Further endpoints  
 NTB memory domain subscale
  Adjusted mean (SE) change from baseline 0.34 (0.053) 0.27 (0.055) 0.25 (0.053) 0.15 (0.054) 0.26 (0.04)
  p value* 0.22 0.81 0.92 0.10
 NTB executive-function domain subscale
  Adjusted mean (SE) change from baseline − 0.04 (0.062) − 0.02 (0.064) 0.07 (0.062) 0.01 (0.063) 0.05 (0.046)
  p value* 0.22 0.38 0.77 0.56
 NTB immediate-memory domain subscale
  Adjusted mean (SE) change from baseline 0.37 (0.066) 0.32 (0.069) 0.38 (0.067) 0.22 (0.068) 0.38 (0.05)
  p value* 0.95 0.50 0.95 0.06
  1. ADAS-Cog11 Alzheimer’s Disease Assessment Scale-cognitive subscale, ADCS-ADL Alzheimer’s Disease Cooperative Study-Activities of Daily Living scale, ADCS-MCI-ADL Alzheimer’s Disease Cooperative Study-Activities of Daily Living for mild cognitive impairment, BID twice daily, CDR-SB Clinical Dementia Rating scale-Sum of Boxes, NTB Neuropsychological Test Battery, QD once daily, SE standard error
  2. *p values represent the comparison of each dose group with placebo