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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.