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A pilot randomized controlled trial evaluating an integrated treatment of rivastigmine transdermal patch and cognitive stimulation in patients with Alzheimer's disease
Author(s) -
D'Onofrio Grazia,
Sancarlo Daniele,
Addante Filomena,
Ciccone Filomena,
Cascavilla Leandro,
Paris Francesco,
Elia Anna Chiara,
Nuzzaci Claudia,
Picoco Michele,
Greco Antonio,
Panza Francesco,
Pilotto Alberto
Publication year - 2015
Publication title -
international journal of geriatric psychiatry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.28
H-Index - 129
eISSN - 1099-1166
pISSN - 0885-6230
DOI - 10.1002/gps.4247
Subject(s) - geriatric depression scale , rivastigmine , clinical dementia rating , medicine , activities of daily living , randomized controlled trial , dementia , depression (economics) , rating scale , physical therapy , alzheimer's disease , mini–mental state examination , psychology , disease , cognition , psychiatry , donepezil , depressive symptoms , developmental psychology , economics , macroeconomics
Objective To evaluate in a pilot single‐blind randomized controlled clinical trial the efficacy of an integrated treatment with rivastigmine transdermal patch (RTP) and cognitive stimulation (CS) in Alzheimer's disease (AD) patients at 6‐month follow‐up. Methods We enrolled 90 patients with an age ≥65 years admitted to the outpatient Alzheimer's Evaluation Unit with diagnosis of AD. Patients were randomized to enter in the Group‐1 (RTP + CS) or in the Group‐2 (RTP). All patients at baseline and after 6 months were evaluated with the following tools: Mini Mental State Examination (MMSE), Clinical Dementia Rating (CDR), Hamilton Rating Scale for Depression (HAM‐D), Geriatric Depression Scale (GDS‐15), Neuropsychiatric Inventory (NPI), Neuropsychiatric Inventory‐Distress (NPI‐D), and a standardized Comprehensive Geriatric Assessment, including also activities of daily living (ADL), instrumental activities of daily living (IADL), and the Mini Nutritional Assessment (MNA). Mortality risk was assessed using the Multidimensional Prognostic Index (MPI). Results At baseline no significant difference was shown between the two groups. After 6 months of follow‐up, there were significant differences between Group‐1 and Group‐2 in: MMSE: +6.39% vs. +2.69%, CDR: +6.92% vs. +1.54%, HDRS‐D = −60.7% vs. −45.8%, GDS: −60.9% vs. −7.3%, NPI: −55.2% vs. −32.7%%, NPI‐D: −55.1% vs. −18.6%, ADL: +13.88% vs. +5.95%, IADL: +67.59% vs. +18.28%, MNA: +12.02% vs. +5.91%, and MPI: −29.03% vs. −12.90%. Conclusion The integrated treatment of RTP with CS in AD patients for 6 months improved significantly cognition, depressive and neuropsychiatric symptoms, functional status, and mortality risk in comparison with a group of AD patients receiving only RTP. Copyright © 2014 John Wiley & Sons, Ltd.