The objective of this study was to compare the efficacy and safety of Capsule of Crocus sativus to memantine, in patients with severe Alzheimer’s disease, over 52 weeks. Patients with severe Alzheimer’s disease aged between 60-95 years will be randomized to Capsule memantine(10 mg twice per day) or Capsule of Crocus Sativus (15 mg twice per day) for 1 year. The main efficacy measures will be the change in the Scirs and FAST scores compared to baseline at week 52. Secondary outcomes will be change in scores at Scirs and FAST every 4 weeks. In addition, side effects will be systematically recorded
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203051556N39
Registration date:2012-03-11, 1390/12/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-03-11, 1390/12/21
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
2012-04-03, 1391/01/15
Expected recruitment end date
2013-05-05, 1392/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Saffron Versus Memantine in patients with severe Alzheimer's disease: randomized double-blind placebo-controlled study
Public title
Comparison of effect of Saffron versus memantine in patients with severe Alzheimer's disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: A diagnosis of 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 severe dementia: MMSE8-14]. 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 60 years old to 80 years old
Gender
Both
Phase
2-3
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
Keshavarz Boulevard
City
Tehran
Postal code
Approval date
2012-02-20, 1390/12/01
Ethics committee reference number
16507
Health conditions studied
1
Description of health condition studied
Alzheimer's disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Alzheimer's severity
Timepoint
Every month
Method of measurement
SCIRS
Secondary outcomes
1
Description
Severity of Alzheimer
Timepoint
Every Month
Method of measurement
FAST
Intervention groups
1
Description
capsule Saffron 15 mg twice per day for one year
Category
Treatment - Drugs
2
Description
capsule memantine 10 mg twice per day for one year
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychiatric Research Center, Roozbeh Hospital
Full name of responsible person
Shahin Akhondzadeh
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar Fotouhi
Street address
Keshavarz Boulevard
City
Tehran
Grant name
Grant code / Reference number
16507
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
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Position
Professor of clinical neuropsychopharmacology
Other areas of specialty/work
Street address
Roozbeh hospital
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
s.akhond@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Position
Professor of Clinical Neuropsychopharmacology
Other areas of specialty/work
Street address
Roozbeh Hospital
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
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
Shahin Akhondzadeh
Position
Professor of clinical neuropsychopharmacology
Other areas of specialty/work
Street address
Roozbeh hospital
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
s.akhond@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)