TABLE 1.

Baseline characteristics of participants included in full‐analysis set.

	Intervention group (n = 215)	Control group (n = 218)
Sex
Male	103 (48%)	104 (48%)
Female	112 (52%)	114 (52%)
Age, years	74.3 (5.0)	74.4 (4.8)
Education, years	12.6 (2.5)	12.5 (2.4)
Barthel Index	99.4 (2.7)	99.4 (3.3)
Lawton Index
Male (/5)	4.8 (0.4)	4.9 (0.4)
Female (/8)	7.9 (0.3)	7.9 (0.3)
Age‐ and education‐adjusted cognitive decline
1.0 to < 1.5 SD	76 (35%)	86 (39%)
≥1.5 SD	139 (65%)	132 (61%)
Presence of memory impairment	85 (40%)	85 (39%)
APOE ε4 carrier a	70/212 (33%)	54/214 (25%)
Comorbidities
Diabetes	32 (15%)	36 (17%)
Hypertension	100 (47%)	100 (46%)
Dyslipidemia	80 (37%)	77 (35%)
Neuropsychological test
Composite score (mean Z‐score)	−0.02 (0.56)	0.02 (0.60)
MMSE	27.8 (1.9)	27.6 (1.8)
FCSRT	44.6 (6.5)	44.8 (5.3)
Logical memory
Immediate recall	16.8 (7.5)	17.4 (7.6)
Delayed recall	11.5 (7.7)	11.8 (7.8)
Digit symbol substitution test	53.1 (14.3)	54.7 (16.0)
Trail Making Test
Part A	60.0 (25.7)	60.8 (27.1)
Part B	121.4 (62.1)	116.3 (63.4)
Digit span
Forward	8.1 (1.9)	8.3 (2.0)
Backward	5.2 (1.6)	5.3 (1.8)
Letter word fluency test	9.4 (3.4)	9.3 (3.3)
Dementia‐related plasma biomarkers a
Aβ (composite biomarkers)	0.05 (0.72)	−0.09 (0.77)
p‐tau181 (pg/mL)	1.94 (0.89)	1.97 (1.09)
NfL (pg/mL)	24.44 (11.48)	23.57 (13.40)
GFAP (pg/mL)	235.01 (171.31)	220.11 (110.68)

Note: Data are presented as n (%), n/N (%), or mean (SD).

Abbreviations: Aβ, amyloid beta; APOE, apolipoprotein E; FCSRT, Free and Cued Selective Reminding Test; GFAP, glial fibrillary acidic protein; MMSE, Mini–Mental State Examination; NfL, neurofilament light chain; p‐tau181, tau phosphorylated at threonine 181; SD, standard deviation.

^a Data are not available for all randomized participants.