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Table 2 Summary of efficacy outcomes at weeks 12 and 24

From: Masitinib as an adjunct therapy for mild-to-moderate Alzheimer's disease: a randomised, placebo-controlled phase 2 trial

  Week 12 Week 24
Treatment arm Masitinib treatment Placebo P value Masitinib treatment Placebo P value
ADAS-Coga       
   Evaluable patients 17 6   16 6  
   Improvementb 7 (41%) 1 (17%) 0.369 6 (38%) 1 (17%) 0.616
   Worseningb 1 (6%) 3 (50%) 0.040 1 (6%) 3 (50%) 0.046
   Mean absolute change -2.6 ± 3.6 4.2 ± 6.6 0.016 -1.8 ± 6.1 5.8 ± 7.9 0.030
ADCS-ADLc       
   Evaluable patients 16 6   15 6  
   Improvementd 8 (50%) 0 (0%) 0.051 9 (60%) 1 (17%) 0.149
   Worseningd 5 (31%) 3 (50%) 0.624 4 (27%) 3 (50%) 0.354
   Mean absolute change 6.9 ± 10.9 -4.2 ± 6.9 0.035 5.5 ± 15.8 -1.8 ± 7.0 0.128
MMSEc       
   Evaluable patients 17 7   16 7  
   Mean absolute change 0.1 ± 2.5 -2.1 ± 2.5 0.047 -0.1 ± 4.3 -3.3 ± 3.3 0.031
CDR responsee       
   Evaluable patients 17 7 0.778* 16 7 0.293*
   Response 2 (12%) 1 (14%)   3 (19%) 1 (14%)  
   No change 14 (82%) 5 (71%)   12 (75%) 4 (57%)  
   Worsening 1 (6%) 1 (14%)   1 (6%) 2 (29%)  
CIBIC-Plus       
   Evaluable patients 17 6 0.292* 16 6 0.474*
   Response (1 to 3) 1 (6%) 1 (17%)   2 (13%) 0  
   No change (4) 14 (82%) 2 (33%)   12 (75%) 5 (83%)  
   Worsening (5 to 7) 2 (12%) 3 (50%)   2 (13%) 1 (17%)  
  1. Summary of efficacy outcomes at weeks 12 and 24 according to observed cases dataset analysis on the intent-to-treat population. Data presented as mean ± standard deviation, or number (%). Week 12 data for closed study centre (n = 8 patients) was imputed using last observation carried forward for week 24. ADAS-Cog, Alzheimer's Disease Assessment Scale - cognitive subscale; ADCS-ADL, Alzheimer's Disease Cooperative Study Activities of Daily Living; CDR, Clinical Dementia Rating; CIBIC-plus, Clinician's Interview-Based Impression of Change-plus caregiver input; MMSE, Mini-Mental State Examination. aNegative change reflects improvement. bADAS-Cog response criteria were improvement (decrease ≥4), worsening (increase ≥4). cPositive change reflects improvement. dADCS-ADL response criteria were improvement (increase ≥3), worsening (decrease <0). eCDR response criteria were positive response (decrease > 0), worsening (increase > 0). *Global P value.