TABLE 5.

Changes in ALS clinical disease progression measures and body composition computed using the ALS-specific equation 6 mo after baseline visit in male and female subjects from Cohort #3¹

	Baseline	6 mo	Difference, 6 mo–baseline	Annualized percentage change	P value2
All subjects (n = 213)
BMI	27.1 ± 4.7	26.3 ± 4.7	−0.8 ± 2.0	−5.9	<0.001
ALSFRS-R	38.2 ± 5.4	33.9 ± 7.2	−4.5 ± 5.7	−29.8	<0.001
%FVC	85.2 ± 20.3	75.3 ± 27.3	−11.9 ± 19.9	−27.9	<0.001
FM—ALS-specific equation, kg	27.4 ± 12.7	25.7 ± 12.2	−1.7 ± 4.5	−12.4	<0.001
LBM—ALS-specific equation, kg	52.1 ± 11.4	51.6 ± 11.2	−0.5 ± 1.5	−1.9	<0.001
FM—Deurenberg equations, kg	27.3 ± 9.8	25.9 ± 9.4	−1.5 ± 3.9	−10.9	<0.001
LBM—Deurenberg equations, kg	52.2 ± 11.6	51.4 ± 11.4	−0.8 ± 2.0	−3.0	<0.001
Males (n = 134)
BMI	27.7 ± 4.1	26.8 ± 4.3	−1.0 ± 1.9	−7.2	<0.001
ALSFRS-R	37.5 ± 5.6	32.7 ± 5.8	4.8 ± 6.0	−32.5	<0.001
%FVC	82.2 ± 23.6	70.1 ± 19.5	12.7 ± 20.5	−30.9	<0.001
FM—ALS-specific equation, kg	26.0 ± 11.7	24.1 ± 11.8	−2.0 ± 4.1	−15.4	0.004
LBM—ALS-specific equation, kg	60.3 ± 4.4	59.6 ± 4.7	−0.8 ± 1.7	−2.7	0.14
FM—Deurenberg equations, kg	26.8 ± 8.8	25.0 ± 9.0	−1.8 ± 3.7	−13.4	<0.001
LBM—Deurenberg equations, kg	59.6 ± 7.3	58.4 ± 7.6	−1.2 ± 2.2	−4.0	<0.001
Females (n = 79)
BMI	26.1 ± 5.6	25.6 ± 5.2	−1.2 ± 5.3	−2.6	0.05
ALSFRS-R	36.4 ± 6.2	32.2 ± 5.7	4.0 ± 5.3	−28.2	<0.001
%FVC	79.1 ± 19.5	68.4 ± 18.6	10.8 ± 18.3	−27.3	<0.001
FM—ALS-specific equation, kg	29.7 ± 13.9	28.5 ± 12.4	−1.2 ± 5.0	−8.0	0.003
LBM—ALS-specific equation, kg	38.3 ± 3.4	38.2 ± 3.6	−0.1 ± 1.5	−0.5	0.015
FM—Deurenberg equations, kg	28.2 ± 11.3	27.2 ± 10.0	−1.0 ± 13.1	−7.1	0.04
LBM—Deurenberg equations, kg	39.7 ± 5.3	39.5 ± 5.4	−0.2 ± 1.4	−1.0	0.16

¹All values are means ± SDs, unless indicated otherwise. BMI in kg/m². ALS, amyotrophic lateral sclerosis; ALSFRS-R, ALS functional rating scale-revised (normal = 48); FM, fat mass; LBM, lean body mass; %FVC, forced vital capacity (corrected for age, sex, and height).

² P values are from paired t tests, 6 mo compared with baseline.