|
Effect
|
Maximum likelihood estimates
|
|---|
|
Parameter
|
Week 24
|
Week 48
|
|---|
|
Estimate
a
|
Pr > ChiSq
|
Estimate
a
|
Pr > ChiSq
|
|---|
|
‘Improvers’
|
|
Treatmentb
|
Treatment 9.5 mg/24 h patch
|
−0.580
|
0.0001
|
−0.461
|
0.021
|
|
Gender
|
Female
|
0.234
|
0.137
|
−0.040
|
0.014
|
|
ADAS-cogc
|
ADAS-cogc
|
0.044
|
0.017
|
−0.438
|
0.059
|
|
ADCS-IADLc
|
ADCS-IADLc
|
−0.026
|
0.050
|
na
|
na
|
|
MMSEc
|
MMSE ≤12c
|
−0.854
|
<0.0001
|
na
|
na
|
|
‘Non-decliners’
|
|
Treatmentb
|
Treatment 9.5 mg/24 h patch
|
−0.337
|
0.002
|
−0.270
|
0.058
|
|
Gender
|
Female
|
0.218
|
0.094
|
na
|
na
|
|
ADAS-cogc
|
ADAS-cogc
|
0.031
|
0.014
|
na
|
na
|
|
ADCS-IADLc
|
ADCS-IADLc
|
na
|
na
|
−0.027
|
0.020
|
|
MMSEc
|
MMSE ≤12c
|
−0.497
|
0.002
|
−0.351
|
0.040
|
|
Weight, versus >80 kg
|
Weight 50 to 80 kg
|
−0.363
|
0.068d
|
−0.405
|
0.119d
|
| |
Weight <50 kg
|
0.208
|
0.344
|
-
aPositive estimate indicates increased odds of response when increasing the value of the covariate, or when in the given category. Negative estimated effect means reduced odds of response. bTreatment effect compares 9.5 mg/24 h to 13.3 mg/24 h rivastigmine patch. cAt DB-BL. dAll categories combined. Candidate covariates were: treatment, gender, ADAS-cog score at DB-BL, ADCS-IADL score at DB-BL, MMSE score of ≤12 at DB-BL and weight category (<50, 50 to 80 and >80 kg). ‘Improver’ = patient with an improvement from DB-BL in ADAS-cog score ≥4 points and a change from DB-BL in ADCS-IADL score ≥0 points; ‘non-decliner’ = patient with a change from DB-BL in ADAS-cog score ≤0 points and a change from DB-BL in ADCS-IADL score ≥0 points. ADAS-cog, Alzheimer’s Disease Assessment Scale–cognitive subscale; ADCS-IADL, Instrumental domain of the Alzheimer’s Disease Cooperation Study–Activities of Daily Living scale; DB-BL, double-blind baseline; MMSE, Mini-Mental State Examination; na, not applicable because effect not selected as relevant by the stepwise regression model – only variables (effects) with a P-value <0.15 were included in the final model. Treatment was always retained within the model; Pr > ChiSq, P-value of the Chi-Square test.
