A pilot randomized controlled trial evaluating an integrated treatment of rivastigmine transdermal patch and cognitive stimulation in patients with Alzheimer's disease

Grazia D'Onofrio, Daniele Sancarlo, Filomena Addante, Filomena Ciccone, Leandro Cascavilla, Francesco Paris, Anna Chiara Elia, Claudia Nuzzaci, Michele Picoco, Antonio Greco, Francesco Panza, Alberto Pilotto

Research output: Contribution to journalArticlepeer-review

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 ≥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.

Original languageEnglish
Pages (from-to)965-975
Number of pages11
JournalInternational Journal of Geriatric Psychiatry
Volume30
Issue number9
DOIs
Publication statusPublished - Sep 1 2015

Keywords

  • Alzheimer's disease
  • cognitive stimulation
  • comprehensive geriatric assessment
  • multidimensional prognostic index
  • rivastigmine transdermal patch

ASJC Scopus subject areas

  • Geriatrics and Gerontology
  • Psychiatry and Mental health

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