Variable

Placebo

N=34

ORM-12741

30-60 mg

N=33

ORM-12741

100-200 mg

N=33

Total

N=100

Number (%) of subjects

Intent-to-treat population (ITT) 34 (100) 33 (100) 33 (100) 100 (100)

Per-protocol population (PP) 29 (85.3) 27 (81.8) 29 (87.9) 85 (85.0)

Completed study 33 (97.1) 28 (84.8) 30 (90.9) 91 (91.0)

Discontinued study 1 (2.9) 5 (15.2) 3 (9.1) 9 (9.0)

Variable Placebo

N=34

ORM-12741

30-60 mg

N=33

ORM-12741

100-200 mg

N=33

Total

N=100

Sex, n (%) Female 17 (50.0) 19 (57.6) 23 (69.7) 59 (59.0)

Male 17 (50.0) 14 (42.4) 10 (30.3) 41 (41.0)

Age, years Mean 72.3 71.8 71.8 72.0

Range 56-90 55-87 56-87 55-90

MMSE scores Mean 18.1 18.6 19.0 18.5

Range 12-21 13-21 13-21 12-21

Variable

Placebo

N=34

ORM-12741

30-60 mg

N=33

ORM-12741

100-200 mg

N=33

Number (%) of subjects

Subjects with AEs 21 (61.8) 18 (54.5) 21 (63.3)

Subjects with related AEs 6 (17.6) 8 (24.2) 10 (30.3)

Subjects with serious AEs 0 0 1 (3.0)1

Discontinued due to AE 0 1 (3.0) 2 (6.1)

Dose reduced due to AE 3 (8.8) 2 (6.1) 3 (9.1)

1 Cholestasis (asymptomatic high AST, ALT, GGT and ALP)

Variable

Placebo

N=34

ORM-12741

30-60 mg

N=33

ORM-12741

100-200 mg

N=33

Number (%) of subjects

Headache 4 (11.8) 2 (6.1) 1 (3.0)

Urinary tract infection 3 (8.8) 1 (3.0) 5 (15.2)

Nausea 3 (8.8) 2 (6.1) 1 (3.0)

Vomiting 1 (2.9) 1 (3.0) 4 (12.1)

Diarrhoea 2 (5.9) 2 (6.1) 1 (3.0)

Irritability 3 (8.8) - 2 (6.1)