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Reality orientation therapy combined with cholinesterase inhibitors in Alzheimer's disease: randomised controlled trial

  • Graziano Onder (a1), Orazio Zanetti (a2), Ezio Giacobini (a3), Giovanni B. Frisoni (a4), Luisa Bartorelli (a5), Gabriele Carbone (a6), Paola Lambertucci (a7), Maria Caterina Silveri (a7) and Roberto Bernabei (a7)...

Reality orientation therapy combined with cholinesterase inhibitors has not been evaluated in patients with Alzheimer's disease.


To perform such an evaluation.


We randomly assigned 79 of 156 patients treated with donepezil to receive a reality orientation programme. Caregivers of the treatment group were trained to offer the programme at home 3 days a week, 30 min/day for 25 consecutive weeks, and were invited to stimulate and involve patients in reality-based communication.


The treatment group showed a slight improvement in Mini-Mental State Examination (MMSE) scores (mean change + 0.2, s.e. = 0.4) compared with a decline in the control group (mean change −1.1, s.e. =0.4; P=0.02). Similarly for the Alzheimer's Disease Assessment Scale – Cognition (treatment group mean change +0.4, s.e.=0.8; control group –2.5, s.e.=0.8; P = 0.01). The intervention had an equal effect on cognition in those with mild (MMSE score ⩾20) and moderate (score < 20) dementia. No significant effect was observed for behavioural and functional outcomes.


Reality orientation enhances the effects of donepezil on cognition in Alzheimer's disease.

Corresponding author
Graziano Onder, Centro Medicina dell'Invecchiamento, Università Cattolica del Sacro Cuore, L. go Francesco Vito 1, 00168 Roma, Italy. Tel: +39 06 30154341; fax: +39 06 3051911; e-mail:
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Declaration of interest

O.Z. is on the speaker bureau of Pfizer, Novartis, Janssen-Cilag and Bracco; R.B. has received honoraria from Pfizer. Funding from the Italian Ministry of Health.

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Baines, S., Saxby, P. & Ehlert, K. (1987) Reality orientation and reminiscence therapy. A controlled cross-over study of elderly confused people. British Journal of Psychiatry, 151, 222231.
Bianchetti, A., Padovani, A. & Trabucchi, M. (2003) Outcomes of Alzheimer's disease treatment: the Italian CRONOS project. International Journal of Geriatric Psychiatry, 18, 8788.
Cook, R. J. & Sackett, D. L. (1995) The number needed to treat: a clinically useful measure of treatment effect. BMJ, 310, 452454.
Courtney, C., Farrell, D., Gray, R., et al (2004) Long-term donepezil treatment in 565 patients with Alzheimer's disease (AD2000): randomised double-blind trial. Lancet, 363, 21052115.
Cummings, J. L., Mega, M., Gray, K., et al (1994) The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology, 44, 23082314.
Farlow, M. R., Hake, A., Messina, J., et al (2001) Response of patients with Alzheimer disease to rivastigmine treatment is predicted by the rate of disease progression. Archives of Neurology, 58, 417422.
Feldman, H., Gauthier, S., Hecker, J., et al (2001) A 24-week, randomized, double-blind study of donepezil in moderate to severe Alzheimer's disease. Neurology, 57, 613620.
Folstein, M. F., Folstein, S. E. & McHugh, P. R. (1975) ‘Mini-mental state’. A practical method for grading the cognitive state of patients for the clinician. Journal of Psychiatric Research, 12, 189198.
Hamilton, M. (1959) The assessment of anxiety states by rating. British Journal of Medical Psychology, 32, 5055.
Hamilton, M. (1967) Development of a rating scale for primary depressive illness. British Journal of Social and Clinical Psychology, 6, 278296.
Jonsson, L., Lindgren, P., Wimo, A., et al (1999) Costs of Mini Mental State Examination-related cognitive impairment. Pharmacoeconomics, 16, 409416.
Lawton, M. P. & Brody, E. M. (1969) Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist, 9, 179186.
Mahoney, F. I. & Barthel, D. W. (1965) Functional evaluation: The Barthel Index. Maryland State Medical Journal, 14, 6165.
McKhann, G., Drachman, D., Folstein, M., et al (1984) Clinical diagnosis of Alzheimer's disease: report of the NINCDS-ADRDA Work Group under the auspices of Department of Health and Human Services Task Force on Alzheimer's Disease. Neurology, 34, 939944.
Metitieri, T., Zanetti, O., Geroldi, C., et al (2001) Reality orientation therapy to delay outcomes of progression in patients with dementia. A retrospective study. Clinical Rehabilitation, 15, 471478.
Novak, M. & Guest, C. (1989) Application of a multidimensional caregiver burden inventory. Gerontologist, 29, 798803.
Onder, G., Penninx, B. W., Lapuerta, P., et al (2002) Change in physical performance over time in older women: the Women's Health and Aging Study. Journal of Gerontology Series A: Biological Sciences and Medical Sciences, 57, M289–293.
Rosen, W. G., Mohs, R. C. & Davis, K. L. (1984) A new rating scale for Alzheimer's disease. American Journal of Psychiatry, 141, 13561364.
Spector, A., Orrell, M., Davies, S., et al (2000a) Reality orientation for dementia. Cochrane Database of Systematic Reviews, Issue 4, CD0011199. Oxford: Update Software.
Spector, A., Davies, S., Woods, B., et al (2000b) Reallity orientation for dementia: a systematic review of the evidence of effectiveness from randomized controlled trials. Gerontofogist, 40, 206212.
Spector, A., Thorgrimsen, L., Woods, B., et al (2003) Efficacy of an evidence-based cognitive stimulation therapy programme for people with dementia: Randomised controlled trial. British Journal of Psychiatry, 183, 248254.
Tarlov, A. R., Ware, J. E., Greenfield, S., et al (1989) The Medical Outcomes Study: an application of methods for monitoring the results of medical care. JAMA, 262, 925930.
Trinh, N. H., Hoblyn, J., Mohanty, S., et al (2003) Efficacy of cholinesterase inhibitors in the treatment of neuropsychiatric symptoms and functional impairment in Alzheimer disease: a meta-analysis. JAMA, 289, 210216.
Zanetti, O., Frisoni, G. B., De Leo, D., et al (1995) Reality orientation therapy in Alzheimer disease: useful or not? A controlled study. Alzheimer Disease and Associated Disorders, 9, 132138.
Zanetti, O., Oriani, M., Geroldi, C., et al (2002) Predictors of cognitive improvement after reality orientation in Alzheimer's disease. Age and Ageing, 31, 193196.
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Reality orientation therapy combined with cholinesterase inhibitors in Alzheimer's disease: randomised controlled trial

  • Graziano Onder (a1), Orazio Zanetti (a2), Ezio Giacobini (a3), Giovanni B. Frisoni (a4), Luisa Bartorelli (a5), Gabriele Carbone (a6), Paola Lambertucci (a7), Maria Caterina Silveri (a7) and Roberto Bernabei (a7)...
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