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


CONCLUSIONS
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).
Akhondzadeh
Shahin
S
Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, South Kargar Street, Tehran 13337, Iran. s.akhond@neda.net
Shafiee Sabet
Mehdi
M
Harirchian
Mohammad Hossein
MH
Togha
Mansoreh
M
Cheraghmakani
Hamed
H
Razeghi
Soodeh
S
Hejazi
Seyyed Shamssedin
SS
Yousefi
Mohammad Hossein
MH
Alimardani
Roozbeh
R
Jamshidi
Amirhossein
A
Rezazadeh
Shams-Ali
SA
Yousefi
Aboulghasem
A
Zare
Farhad
F
Moradi
Atbin
A
Vossoughi
Ardalan
A
D000368:Aged; D000544:Alzheimer Disease / Q000188:drug therapy* / Q000503:physiopathology; D002800:Cholinesterase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D027622:Crocus / Q000737:chemistry*; D000077265:Donepezil; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007189:Indans / Q000009:adverse effects / Q000627:therapeutic use*; D007492:Iran; D008297:Male; D010880:Piperidines / Q000009:adverse effects / Q000627:therapeutic use*; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D012720:Severity of Illness Index
D002800:Cholinesterase Inhibitors; D007189:Indans; D010880:Piperidines; D010936:Plant Extracts; D000077265:Donepezil