title: A pilot randomized controlled trial evaluating an integrated treatment of rivastigmine transdermal patch and cognitive stimulation in patients with Alzheimer's disease.
abstract: 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%.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Geriatric Unit & Laboratory of Gerontology and Geriatrics, Department of Medical Sciences, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.
authors.forename: Grazia
authors.initials: G
authors.lastname: D'Onofrio
authors.affiliation: Geriatric Unit & Laboratory of Gerontology and Geriatrics, Department of Medical Sciences, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.
authors.forename: Daniele
authors.initials: D
authors.lastname: Sancarlo
authors.affiliation: Geriatric Unit & Laboratory of Gerontology and Geriatrics, Department of Medical Sciences, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.
authors.forename: Filomena
authors.initials: F
authors.lastname: Addante
authors.affiliation: Geriatric Unit & Laboratory of Gerontology and Geriatrics, Department of Medical Sciences, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.
authors.forename: Filomena
authors.initials: F
authors.lastname: Ciccone
authors.affiliation: Geriatric Unit & Laboratory of Gerontology and Geriatrics, Department of Medical Sciences, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.
authors.forename: Leandro
authors.initials: L
authors.lastname: Cascavilla
authors.affiliation: Geriatric Unit & Laboratory of Gerontology and Geriatrics, Department of Medical Sciences, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Paris
authors.affiliation: Geriatric Unit & Laboratory of Gerontology and Geriatrics, Department of Medical Sciences, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.
authors.forename: Anna Chiara
authors.initials: AC
authors.lastname: Elia
authors.affiliation: Geriatric Unit & Laboratory of Gerontology and Geriatrics, Department of Medical Sciences, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.
authors.forename: Claudia
authors.initials: C
authors.lastname: Nuzzaci
authors.affiliation: Geriatric Unit & Laboratory of Gerontology and Geriatrics, Department of Medical Sciences, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Picoco
authors.affiliation: Geriatric Unit & Laboratory of Gerontology and Geriatrics, Department of Medical Sciences, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Greco
authors.affiliation: Geriatric Unit & Laboratory of Gerontology and Geriatrics, Department of Medical Sciences, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.|Neurodegenerative Disease Unit, Department of Basic Medicine, Neuroscience, and Sense Organs, University of Bari Aldo Moro, Bari, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Panza
authors.affiliation: Geriatric Unit & Laboratory of Gerontology and Geriatrics, Department of Medical Sciences, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.|Geriatrics Unit, Azienda ULSS 16 Padova, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Pilotto
mesh_terms: D000203:Activities of Daily Living; D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000401:mortality / Q000523:psychology / Q000628:therapy*; D015928:Cognitive Behavioral Therapy; D003131:Combined Modality Therapy; D005260:Female; D005500:Follow-Up Studies; D015577:Geriatric Assessment / Q000379:methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D018696:Neuroprotective Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D010865:Pilot Projects; D011569:Psychiatric Status Rating Scales; D012307:Risk Factors; D000068836:Rivastigmine / Q000008:administration & dosage / Q000627:therapeutic use*; D057968:Transdermal Patch
chemical_list: D018696:Neuroprotective Agents; D000068836:Rivastigmine
keywords: Alzheimer's disease; cognitive stimulation; comprehensive geriatric assessment; multidimensional prognostic index; rivastigmine transdermal patch