[Risperidone in the treatment of psychotic, affective and behavioral symptoms associated to Alzheimer's disease]

A total of 235 patients with diagnoses of Alzheimer's dementia together with psychotic and/or affective symptomatology, as well as behavioral disturbances was included in an open label postmarketing surveillance study. The study objectives were to asses: 1) risperidone efficiency in psychotic and affective symptomatology and behavioral disturbances; 2) risperidone influence in the patient's performance, 3) dosage range at which efficiency is observed; and 4) safety in this group of patients. Patients were observed during a six month period. Risperidone was used at a mean dosage of 1.23 +/- 0.86 mg daily (range: 0.5-4.5 mg daily).

Risperidone was assessed by the Clinical Global Impression (CGI), Geriatric Depression Scale (GDS), Neuropsychiatric Inventory (NPI), Clinical Deterioration Rating (CDR), UKU subscale for neurological side effects and spontaneous reports. Patients were evaluated at baseline, 15 days and months 1, 2, 4 and 6. Sixteen patients (6.8%) were excluded from the statistical analysis due to protocol violation. Fifty four patients (24.7%) dropped out.

Risperidone produced a significant improvement in the mean total scores of CGI, NPI, GDS (patient's satisfaction, hope.) and CDR (judgment and problem solving, community affairs, hobbies.) scales. Extrapyramidal symptoms improved from day 15 onwards in patients who had received antipsychotic treatment previously; in naive treated patients these symptoms did not change during the study period.

Risperidone was well tolerated. Only 6 (2. 7%) discontinued treatment due to adverse events. Ninety seven percent of the patients did not suffer any adverse event; the resting 2.7% suffered one or more side effects: sedation (1.4%), constipation (0.5%) and vomiting (0.5%) among others.