A 22-week, multicenter, randomized, double-blind controlled trial of Crocus sativus in the treatment of mild-to-moderate Alzheimer’s disease

Rationale There is increasing evidence to suggest the possible efficacy of Crocus sativus (saffron) in the management of Alzheimer’s disease (AD). Objective The purpose of the present investigation was to assess the efficacy of C. sativus in the treatment of patients with mild-to-moderate AD. Method...

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Published in:Psychopharmacologia 2010-01, Vol.207 (4), p.637-643
Main Authors: Akhondzadeh, Shahin, Shafiee Sabet, Mehdi, Harirchian, Mohammad Hossein, Togha, Mansoreh, Cheraghmakani, Hamed, Razeghi, Soodeh, Hejazi, Seyyed Shamssedin, Yousefi, Mohammad Hossein, Alimardani, Roozbeh, Jamshidi, Amirhossein, Rezazadeh, Shams-Ali, Yousefi, Aboulghasem, Zare, Farhad, Moradi, Atbin, Vossoughi, Ardalan
Format: Article
Language:English
Subjects:
Adult and adolescent clinical studies
Aged
Alzheimer Disease - drug therapy
Alzheimer Disease - physiopathology
Alzheimer's disease
Biological and medical sciences
Biomedical and Life Sciences
Biomedicine
Cholinesterase Inhibitors - adverse effects
Cholinesterase Inhibitors - therapeutic use
Clinical trials
Crocus
Crocus - chemistry
Degenerative and inherited degenerative diseases of the nervous system. Leukodystrophies. Prion diseases
Double-Blind Method
Female
Humans
Indans - adverse effects
Indans - therapeutic use
Iran
Male
Medical sciences
Neurology
Neurosciences
Organic mental disorders. Neuropsychology
Original Investigation
Pharmacology/Toxicology
Piperidines - adverse effects
Piperidines - therapeutic use
Plant Extracts - adverse effects
Plant Extracts - therapeutic use
Psychiatric Status Rating Scales
Psychiatry
Psychology. Psychoanalysis. Psychiatry
Psychopathology. Psychiatry
Psychopharmacology
Severity of Illness Index
Spices
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Summary:Rationale There is increasing evidence to suggest the possible efficacy of Crocus sativus (saffron) in the management of Alzheimer’s disease (AD). Objective The purpose of the present investigation was to assess the efficacy of C. sativus in the treatment of patients with mild-to-moderate AD. Methods Fifty-four Persian-speaking adults 55 years of age or older who were living in the community were eligible to participate in a 22-week, double-blind study of parallel groups of patients with AD. The main efficacy measures were the change in the Alzheimer’s Disease Assessment Scale—cognitive subscale and Clinical Dementia Rating Scale—Sums of Boxes scores compared with baseline. Adverse events (AEs) were systematically recorded. Participants were randomly assigned to receive a capsule saffron 30 mg/day (15 mg twice per day) or donepezil 10 mg/day (5 mg twice per day). Results Saffron at this dose was found to be effective similar to donepezil in the treatment of mild-to-moderate AD after 22 weeks. The frequency of AEs was similar between saffron extract and donepezil groups with the exception of vomiting, which occurred significantly more frequently in the donepezil group. Conclusion This phase II study provides preliminary evidence of a possible therapeutic effect of saffron extract in the treatment of patients with mild-to-moderate Alzheimer’s disease. This trial is registered with the Iranian Clinical Trials Registry (IRCT138711051556N1).
ISSN:0033-3158
1432-2072
DOI:10.1007/s00213-009-1706-1