TY - JOUR
T1 - A pilot randomized controlled trial evaluating an integrated treatment of rivastigmine transdermal patch and cognitive stimulation in patients with Alzheimer's disease
AU - D'Onofrio, Grazia
AU - Sancarlo, Daniele
AU - Addante, Filomena
AU - Ciccone, Filomena
AU - Cascavilla, Leandro
AU - Paris, Francesco
AU - Elia, Anna Chiara
AU - Nuzzaci, Claudia
AU - Picoco, Michele
AU - Greco, Antonio
AU - Panza, Francesco
AU - Pilotto, Alberto
PY - 2015/9/1
Y1 - 2015/9/1
N2 - 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 ≥65years 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 6months 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 6months 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 6months improved significantly cognition, depressive and neuropsychiatric symptoms, functional status, and mortality risk in comparison with a group of AD patients receiving only RTP.
AB - 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 ≥65years 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 6months 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 6months 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 6months improved significantly cognition, depressive and neuropsychiatric symptoms, functional status, and mortality risk in comparison with a group of AD patients receiving only RTP.
KW - Alzheimer's disease
KW - cognitive stimulation
KW - comprehensive geriatric assessment
KW - multidimensional prognostic index
KW - rivastigmine transdermal patch
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U2 - 10.1002/gps.4247
DO - 10.1002/gps.4247
M3 - Article
C2 - 25504466
AN - SCOPUS:84938216576
VL - 30
SP - 965
EP - 975
JO - International Journal of Geriatric Psychiatry
JF - International Journal of Geriatric Psychiatry
SN - 0885-6230
IS - 9
ER -