Thursday, 21 August 2003
This presentation is part of : Thursday Poster Sessions

PD-062 Effects of Rivastigmine Treatment on the Psychiatric and Behavioral Disturbances of Nursing Home Residents with Moderate-to-Severe Alzheimer’s Disease (Final Results)

Adrian Rabinowicz1, Barbara Koumaras1, Jeffrey L. Cummings2, Mojtaba Noursalehi3, and Dario Mirski1. (1) CNS, Novartis Pharmaceuticals, East Hanover, NJ, USA, (2) Neurology, UCLA, Los Angeles, CA, USA, (3) Biostatistics, Target Research, New Providence, NJ, USA

Objective:To evaluate the effect of rivastigmine on the psychiatric and behavioral disturbances of nursing home residents with moderate to severe probable Alzheimer's disease (AD) and to evaluate the safety of rivastigmine in this population.

Design:A prospective, 26-week, open-label study at 13 primary centers in the United States involving a total of 29 nursing homes.

Materials and Methods:173 nursing home residents with moderate to severe probable AD received rivastigmine 3-12 mg/d for 26 weeks. The Neuropsychiatric Inventory-Nursing Home (NPI-NH) scale for psychiatric and behavioral disturbances; the Mini-Mental State Examination (MMSE) and abbreviated Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) for cognition; and the simplified Clinician's Interview-Based Impression of Change-Plus Caregiver Input (CIBIC-Plus) for global functioning.

Results:After 26 weeks of rivastigmine treatment, the NPI-NH total score showed a mean improvement of 64%, with improvement in the score seen in 59% of patients who had at least one symptom present at baseline. Of the patients with any improvement, 49% demonstrated a clinically meaningful reduction in neuropsychiatric symptoms (>= 30% improvement) from baseline NPI-NH. Significant improvement from baseline was observed in 8 of 12 neuropsychiatric disturbances in patients with the specific symptom present at baseline including delusions, hallucinations, agitation, apathy/indifference, irritability/lability, aberrant motor behavior, night-time behavior, and appetite/eating change (p<0.05). Scores for the specific symptoms were reduced from baseline by 70% (agitation) to 100% (euphoria/elation). Rivastigmine stabilized cognitive performance and global functioning over the 26-week period. At baseline, the MMSE score (mean±SEM) of enrolled patients was 9.2±0.43. At Week 26, the mean MMSE change from baseline score (±SEM) was 0.6±0.32, p=0.074. The CIBIC-Plus was used to assess the magnitude of overall global change in the patient's condition relative to baseline. Scores range from one to seven (1= Markedly Improved, 4 = No change, 7= Markedly Worse). At Week 26, 79% of patients either improved or did not demonstrate any worsening from baseline, while 21% of patients experienced worsening. Fifty-six percent of patients completed the trial; 19% withdrew because of adverse events.

Conclusion:Rivastigmine treatment of AD patients with moderate to severe cognitive impairment benefits behavioral disturbances and stabilizes cognition and global functioning.

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