The objective of this study was to assess the efficacy and safety of Capsule of Crocus sativus, in patients with mild to moderate Alzheimer’s disease, over the 20 weeks. This study will be undertaken in 3 centers in Tehran, Iran. Patients with mild to moderate Alzheimer’s disease aged between 65-80 years with a score of ≥ 12 on the cognitive subscale of Alzheimer’s Disease Assessment Scale (ADAS-cog) and ≤ 2 on the Clinical Dementia Rating (CDR) will be randomized to Donepezil (10 mg/day) or Capsule of Crocus Sativus (30 mg/day). The main efficacy measures will be the change in the ADAS-cog and CDR-SB scores compared to baseline. In addition, side effects will be systematically recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138711051556N1
Registration date:2009-02-12, 1387/11/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-02-12, 1387/11/24
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2006-11-10, 1385/08/19
Expected recruitment end date
2009-04-10, 1388/01/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Saffron extract in the treatment of mild to moderate Alzheimer’s disease: A double blind randomized controlled trial.
Public title
Saffron and Alzheimer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
A diagnosis of probable Alzheimer’s disease according to the criteria of National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer’s Disease and Related Disorders Association (NINCDS/ADRDA); Presence of mild to moderate dementia [score of ≥ 12 on the cognitive subscale of Alzheimer’s Disease Assessment Scale (ADAS-cog) and ≤ 2 on Clinical Dementia Rating Scale (CDR)].
Exclusion Criteria:
Concomitant diseases such as hypertension, congestive heart failure, non-insulin dependent diabetes mellitus and hypothyroidism; Patients with evidence of other neurodegenerative disorders; Any cardiovascular disease likely to prevent completion of the study; Clinically significant psychiatric diseases; Urinary outflow obstruction; Active peptic ulcer; Any history of epilepsy; Significant drug or alcohol misuse; Drugs with anticholinergic effects or cholinomimetic effects.
Age
From 65 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz Blv
City
Tehran
Postal code
Approval date
2005-12-01, 1384/09/10
Ethics committee reference number
4843
Health conditions studied
1
Description of health condition studied
Mild to moderate Alzheimer
ICD-10 code
F00
ICD-10 code description
Dementia in Alzheimer's disease
Primary outcomes
1
Description
Severity of Alzheimer
Timepoint
Every month
Method of measurement
ADAS-cog
Secondary outcomes
1
Description
Severity of Alzheimer
Timepoint
Every Month
Method of measurement
CDR-SB
Intervention groups
1
Description
Intervention: Capsule of Saffron 30 mg/day
Category
Treatment - Drugs
2
Description
Control: Tab Donepezil 10 mg/day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology Ward, Imam Khomeini Hospital, Tehran
Full name of responsible person
Dr. Mehdi Shafiee
Street address
City
2
Recruitment center
Name of recruitment center
Neurology ward, sina Hospital, Tehran
Full name of responsible person
Dr. Mansoureh Togha
Street address
City
3
Recruitment center
Name of recruitment center
Dept Of neurology, Qom University of Medical sciences
Full name of responsible person
Dr. hejazi
Street address
City
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Tehran University of Medical Sciences, Keshavarz Blv
City
Tehran
Grant name
Grant code / Reference number
4843
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
PhD., FBPharmacolS. Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Psychiatric Hospital
City
Tehran
Postal code
13337
Phone
+98 21 6641 8466
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Ph.D., FBPharmacolS, Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Psychiatric Hospital
City
Tehran
Postal code
13337
Phone
+98 21 6641 8466
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)