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Table 1 Subject characteristics and clinical efficacy assessments

From: A phase Ib multiple ascending dose study of the safety, tolerability, and central nervous system availability of AZD0530 (saracatinib) in Alzheimer’s disease

Variable Treatment group (dose of AZD0530)  
Placebo (n = 6) 50 mg (n = 6) 100 mg (n = 6) 125 mg (n = 6) F   P
Age 72.6 ± 9.5 72.6 ± 4.4 71.5 ± 4.9 4.6 ± 7.9 0.57 † 0.19
Sex 3 F, 3 M 5 F, 1 M 2 F, 4 M 3 F, 3 M  
Education (years) 15.0 ± 2.8 15.3 ± 2.7 14.3 ± 2.3 16.8 ± 3.4 0.84 † 0.49
Weight (kg) 6.88 ± 12.1 69.7 ± 8.7 79.6 ± 17.9 65.4 ± 10.4 1.37 † 0.28
MMSE, baseline 23.0 ± 4.1 21.8 ± 3.3 22.2 ± 4.6 20.2 ± 2.3 0.63 † 0.60
MMSE, week 4 25.7 ± 3.3 25.3 ± 2.4 22.7 ± 4.0 22.5 ± 3.3  
MMSE, change 2.7 ± 2.0 3.5 ± 1.9 0.5 ± 3.4 2.3 ± 2.1 2.15 § 0.13
ADAS-cog, baseline 16.7 ± 2.3 20.6 ± 6.7 23.8 ± 4.5 21.6 ± 7.1 1.73 † 0.19
ADAS-cog, week 4 15.2 ± 4.8 18.3 ± 4.5 22.3 ± 8.1 23.0 ± 4.4  
ADAS-cog, change −1.6 ± 4.4 −2.3 ± 3.4 −1.4 ± 5.4 1.4 ± 3.2 1.31 § 0.30
ADCS- ADL, baseline 63.5 ± 9.2 68.7 ± 6.8 67.2 ± 6.4 64.8 ± 3.1 0.67 † 0.58
ADCS- ADL, week 4 67.7 ± 10.6 66.5 ± 6.7 68.2 ± 7.6 66.4 ± 4.3  
ADCS- ADL, change 4.2 ± 5.2 −2.2 ± 4.2 1.0 ± 2.0 1.6 ± 3.4 2.27 ‡ 0.12
CDR-SOB, baseline 5.6 ± 2.2 5.3 ± 1.9 4.8 ± 1.2 5.1 ± 1.8 0.22 † 0.88
CDR-SOB, week 4 5.8 ± 2.4 5.0 ± 1.9 4.8 ± 1.2 5.6 ± 1.9  
CDR-SOB, change 0.2 ± 0.4 −0.3 ± 0.6 0.0 ± 0.0 0.5 ± 0.4 2.60 ‡ 0.08
NPI, baseline 9.5 ± 11.9 6.5 ± 6.1 3.7 ± 4.3 13.2 ± 10.1       ¶ 0.37
NPI, week 4 4.0 ± 5.0 7.7 ± 9.1 2.5 ± 3.5 18.0 ± 8.9  
NPI, change −5.5 ± 8.4 1.2 ± 5.1 −1.2 ± 4.8 4.8 ± 7.6       ¶ 0.09
  1. Values are shown as mean ± standard deviation (apart from sex). F and P values are for analysis of covariance, controlling for baseline score. Analysis of variance. Kruskal-Wallis H test. Analysis of completer subjects only. Week 4 ADCS-ADL and CDR-SOB invalid for subject AZD026, who was residing in skilled nursing facility. §Analysis of all randomized subjects, including AZD026 who discontinued study drug after 9 days; excluding this subject, MMSE change in 125-mg group = 2.8 ± 1.9, F = 2.07, P = 0.140; ADAS-cog change = 1.3 ± 3.5, F = 1.05, P = 0.393; NPI change = 1.8 ± 1.9, P = 0.169, Kruskal-Wallis H test. ADAS-cog, Alzheimer’s Disease Assessment Scale – cognitive subscale; ADCS-ADL, Alzheimer’s Disease Cooperative Study – Activities of Daily Living Inventory; CDR-SOB, Clinical Dementia Rating Scale – Sum of Boxes; F, female; M, male; MMSE, Mini Mental Status Examination; NPI, Neuropsychiatric Inventory.