Table 2.
Efficacy outcome measures in the clinical study
| 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 |
*NTB: Neuropsychological Test Battery evaluating attention, executive function, and visual learning.
The NTB was the primary outcome measure. NTB and Attention composites reported as z-scores.
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.