A 24‐Week, Randomized, Controlled Trial of Rivastigmine Patch 13.3?mg/24?h Versus 4.6?mg/24?h in Severe Alzheimer's Dementia

摘要

Summary Aims The 24‐week, prospective, randomized, double‐blind ACTION study investigated the efficacy, safety, and tolerability of 13.3 versus 4.6 mg/24 h rivastigmine patch in patients with severe Alzheimer's disease ( AD ). Methods Patients had probable AD and Mini–Mental State Examination scores ≥3–≤12. Primary outcome measures were as follows: Severe Impairment Battery ( SIB ) and AD Cooperative Study–Activities of Daily Living scale–Severe Impairment Version ( ADCS ‐ ADL ‐ SIV ). Secondary outcomes were as follows: ADCS ‐Clinical Global Impression of Change ( ADCS ‐ CGIC ), 12‐item Neuropsychiatric Inventory ( NPI ‐12), and safety/tolerability. Results Of 1014 patients screened, 716 were randomized to 13.3 mg/24 h (N = 356) or 4.6 mg/24 h (N = 360) patch. Baseline characteristics/demographics were comparable. Completion rates were as follows: 64.3% (N = 229) with 13.3 mg/24 h and 65.0% (N = 234) with 4.6 mg/24 h patch. The 13.3 mg/24 h patch was significantly superior to 4.6 mg/24 h patch on cognition ( SIB ) and function ( ADCS ‐ ADL ‐ SIV ) at Week 16 ( P Conclusions The 13.3 mg/24 h patch demonstrated superior efficacy to 4.6 mg/24 h patch on SIB and ADCS ‐ ADL ‐ SIV , without marked increase in AE s, suggesting higher‐dose patch has a favorable benefit‐to‐risk profile in severe AD .