Table 2 Efficacy outcome measures in the clinical study

From: Preclinical and randomized clinical evaluation of the p38α kinase inhibitor neflamapimod for basal forebrain cholinergic degeneration

 

All Neflamapimod (NFMD; includes 40 mg BID and 40 mg TID participants) vs. All Placebo

Outcome measure

Number of particpants

Mean baseline values

Change from baseline

 

NFMD

Placebo

NFMD

Placebo

Drug-Placebo Difference On-Study

(95% CI)

p-value

Cohen’s d Effect Size for Improvement - d

NTB* Composite

39

37

  0.04

   0.05

0.04

(−0.11, 0.19)

>0.2

   0.10

Attention Composite

39

36

  0.04

−0.02

0.14

(−0.06, 0.35)

  0.17

   0.18

Clinical Dementia Rating Sum of Boxes (CDR-SB)

41

42

  4.9

   5.1

−0.45

(−0.83, −0.06)

  0.023

   0.31

International Shopping List Test (ISLT)

42

42

14.3

 13.6

−0.17

(−1.61, 0.87)

>0.2

−0.02

Timed Up and Go (TUG)

39

38

12.7

 13.5

−1.4

(−2.7, −0.1)

  0.044

   0.22

  1. *NTB: Neuropsychological Test Battery evaluating attention, executive function, and visual learning.
  2. The NTB was the primary outcome measure. NTB and Attention composites reported as z-scores.
  3. Note: Difference (95% confidence interval, CI) shown is from MMRM (mixed model for repeated measures) analysis. Improvement is reflected as increases in NTB, Attention Composite and the ISLT; and as decreases in CDR-SB and TUG test. Positive d indicates improvement relative to placebo, and negative d indicates worsening relative to placebo.
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