| Sumario: | What is known: Herbal medicines have been used in the treatment of behavioural and psychological symptoms of dementia but with variable response. Crocus sativus (saffron) may inhibit the aggregation and deposition of amyloid β in the human brain and may therefore be useful in Alzheimer’s disease (AD). Objective: The goal of this study was to assess the efficacy of saffron in the treatment of mild to moderate AD. Methods: Forty-six patients with probable AD were screened for a 16-week, double-blind study of parallel groups of patients with mild to moderate AD. The psychometric measures, which included AD assessment scale-cognitive subscale (ADAS-cog), and clinical dementia rating scale-sums of boxes, were performed to monitor the global cognitive and clinical profiles of the patients. Patients were randomly assigned to receive capsule saffron 30 mg/day (15 mg twice per day) (Group A) or capsule placebo (two capsules per day) for a 16-week study. Results: After 16 weeks, saffron produced a significantly better outcome on cognitive function than placebo (ADAS-cog: F = 4·12, d.f. = 1, P = 0·04; CDR: F = 4·12, d.f. = 1, P = 0·04). There were no significant differences in the two groups in terms of observed adverse events. What is new and conclusion: This double-blind, placebo-controlled study suggests that at least in the short-term, saffron is both safe and effective in mild to moderate AD. Larger confirmatory randomized controlled trials are called for.
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