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P1‐298: Tolerability, safety, and efficacy of the 1‐step titration scheme of rivastigmine patch 10 cm 2 in japanese patients with mild‐to‐moderate Alzheimer's disease: A 24‐week randomized controlled study
Author(s) -
Nakamura Yu,
Strohmaier Christine,
Shimozawa Makoto,
Kataoka Naoko,
Nakano Masayuki,
Oda Shoichiro,
Nishimura Kazuma,
Homma Akira
Publication year - 2015
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2015.06.499
Subject(s) - tolerability , rivastigmine , clinical global impression , medicine , discontinuation , adverse effect , titration , randomized controlled trial , dementia , clinical endpoint , randomization , disease , donepezil , placebo , chemistry , inorganic chemistry , alternative medicine , pathology
Primary outcomes NPI total score Baseline 24 37.4 (13.7) 26 35.6 (13.0) Day14 19 31.0 (11.3) 23 26.1 (16.9) Day 21 23 27.8 (13.1) 24 23.9 (16.8) +3.2 (-3.6 to 10.0) NPI agitation/ aggression subscale Baseline 24 5.7 (3.5) 26 6.2 (4.3) Day 14 19 4.1 (4.7) 23 5.0 (3.9) Day 21 23 4.5 (4.1) 24 4.4 (4.3) -0.1 (-2.0 to 1.9) NPI abemant motor behavior behavior subscale Baseline 24 4.5 (4.6) 26 5.2 (4.1) Day14 19 4.9 (4.0) 23 4.3 (4.2) Day 21 23 3.6 (3.9) 24 3.7 (4.3) -0.3 (-1.0 to 1.7) Secondary outcomes CMAI Baseline 24 58.8 (15.5) 26 61.6 (16.4) Day 21 23 56.5 (17.5) 24 53.7 (18.3) -4.6 (-3.0 to 12.2) Barthel Index Baseline 24 13.8 (5.1) 25 13.3 (5.3) Day 21 22 13.3 (5.0) 24 12.0 (5.5) -0.6 (-0.8 to 1.9) QoL-AD Baseline 24 28.3 (4.9) 24 29.6 (5.2) Day 21 21 27.5 (4.6) 22 29.1 (5.0) -0.5 (-2.6 to 1.6) CCGIC* Day 14 20 3.7 (1.0) 25 3.4 (1.2) Day 21 22 3.5 (1.3) 24 3.2 (1.4) -0.2 (-0.5 to 0.9) Safety assessments Heart rate, bpm. Baseline 23 69.8 (11.4) 24 4.5 (12.5) Day 21 22 66.3 (8.6) 24 71.6 (8.0) -3.3 (-7.5 to 0.9) Systolic blood pressure, mmHg Baseline 23 138.6 (21.2) 24 143.1 (15.9) Day 21 22 143.7 (16.8) 24 141.3 (20.9) -3.4 (-6.5 to 12.2) Diastolic blood pressure, mmHg Baseline 23 77.5 (8.0) 24 82.0 (10.4) Day 21 22 76.9 (7-1) 24 8.2 (9.3) -1.8 (-6.6 to 3.1) Weight, kg Baseline 22 71.0 (14.3) 22 70.9 (13.8) Day 21 20 70.4 (13.8) 22 71.1 (12.9) -0.1 (-0.8 to 0.7)