The Efficacy of Transdermal Rivastigmine in Mild to Moderate Alzheimer’s Disease with Concomitant Small Vessel Cerebrovascular Disease: Findings from an Open-Label Study

Figures & data

Table 1 Participant Characteristics

	OC (N = 69)		ITT-LOCF (N = 100)			P value
	Mean	Std. Deviation	Mean	Std. Deviation	T-Statistic (DF)
Age	74.38	6.98	–	–	–	–
Males (%)	48 (48%)	–	–	–	–	–
Body weight (kg)	59	11.48
Blood pressure – Systolic	137.45	19.09
Blood pressure – diastolic	71.03	12.13
Heart rate (beats per min)	67.52	10.25
Years of education	7.58	4.64	–	–	–	–
Fazekas Score	2.23	0.42	–	–	–	–
MMSE
Baseline (OC N=99)	21.45	4.48	21.52	4.45	0.11 (197)	0.91
Week 16 (OC N=81)	20.12	4.63	20.51	4.74	0.55 (179)	0.57
Week 24 (OC N=87)	20.58	5.21	20.83	5.04	0.33 (185)	0.73
ADAS Cog
Baseline (OC N=95)	48.93	8.72	48.93	8.12	0.00 (193)	1.00
Week 16 (OC N=75)	50.42	9.06	50.21	9.21	−0.15 (173)	0.88
Week 24 (OC N=81)	51.25	9.47	50.72	9.59	−.35 (179)	0.72
ADL
Baseline (OC = 100)	61.19	10.26	61.19	10.26	–	–
Week 16 (N= 81)	60.39	11.42	60.26	11.93	0.07 (179)	0.94
Week 24 (N= 85)	61.02	10.96	60.43	11.58	0.35 (183)	0.73

Abbreviations: OC, observed cases; ITT-LOCF, intent to treat-last observation carried forward sample; MMSE, Mini-Mental State Examination; ADAS-Cog, Alzheimer’s disease Assessment Scale-Cognitive subscale; ADL, activities of daily living.

Figure 1 Consort diagram.

Figure 2 The proportion of patients that either responded to treatment and improved in cognitive performance, remained stable or that declined in cognitive performance after 24 weeks.

Figure 3 Frequency of responses on the clinician-rated Clinical Global Impression of Change scale at week 24.

Table 2 Differences in Demographics Between Patients Who Improved, Remained Stable or Who Declined in Cognitive Performance

	Mean (SD)
	Improved	Stable	Declined
	(N = 25)	(N = 27)	(N = 48)
Age	75.61 (6.27)	75.04 (6.44)	73.26 (4.09)
Gender (male)	15 (60%)	15 (55%)	18 (37%)
Education	6.52 (3.84)	10.14 (5.37)	6.68 (4.09)
Fazekas score	2.32 (0.47)	2.25 (0.44)	2.16 (0.37)
Baseline MMSE	19.84 (4.42)	22.53 (4.41)	21.72 (4.36)
Baseline ADAS	48.75 (9.53)	51.68 (8.67)	47.60 (8.15)
Baseline ADL	60.36 (10.35)	58.40 (12.55)	63.18 (8.42)

Table 3 Side Effects Reported by Clinical Interview

Week 8 (N= 3)
	Pruritus
	Palpitation
	Nausea, giddiness
Week 16 (N=10)
	Peripheral vestibulopathy
	Neutropenia, rash
	Rash, dyspepsia
	Nausea, giddiness
	Headache, behavioural change (aggression/low mood)
	Rash contact dermatitis (N=4)
Week 24 (N=3)
	Rash (N=2)
	Worsening behavioral symptoms

Table 4 Vitals Measured at Baseline, Week 16 and Week 24

Vitals	Timeframe	Mean	SD
Systolic blood pressure (mmHg)	Baseline	142.28	29.24
	Week 16	137.76	19.72
	Week 24	138.28	20.28
Diastolic blood pressure (mmHg)	Baseline	70.74	10.54
	Week 16	69.87	10.90
	Week 24	70.31	11.74
Heart rate (beats per min)	Baseline	72.43	10.68
	Week 16	72.20	12.48
	Week 24	67.98	20.85
Weight (kg)	Baseline	58.76	11.48
	Week 16	58.46	12.05
	Week 24	58.31	12.01