Study of the effect of Riluzole on the cognitive function of patients with mild Alzheimer's disease
Design
This study is a randomized clinical trial trial, placebo-controlled, double-blind that will be conducted between 2018 -2019. study population is the patient with mild Alzheimer's disease, aged 60-80 years old. A total of 48 patients are randomly divided into two equal groups of placebo and main drug group. Randomization will be done by using the four block size.
Settings and conduct
Patients referred to Shariati Hospital's neurology clinic and private neurology clinic who are eligible for study are randomly divided into two groups of main drug and placebo. The intervention group received 50 mg oral Riluzole tablets twice a day for three months and the placebo group received in the same way . Patients will be evaluated in terms of disease progression, cognitive function, and memory performance on day one and 90th of study . They are also considered for drug side effects during the study. Patients and the main investigators who measure the outcomes will be blinded to The type of medication .
Participants/Inclusion and exclusion criteria
Patients with mild Alzheimer's disease aged 60-80 years old who received one of the FDA approved anticholinesterase drugs for Alzheimer's treatment from three months ago, will be included in the study, and patients with a history of other types of dementia and other neurological diseases and major psychiatric disorders, and history of hypertension and Uncontrolled diabetes will not be included in the study
Intervention groups
Intervention includes the administration of oral tablets of Riluzole in intervention group and the administration of placebo tablets in the control group.
Main outcome variables
Evaluation of cognitive function; memory performance and progression of Alzheimer's disease are the main outcomes of the study
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100126003181N4
Registration date:2018-03-01, 1396/12/10
Registration timing:prospective
Last update:2018-03-01, 1396/12/10
Update count:0
Registration date
2018-03-01, 1396/12/10
Registrant information
Name
Zahra Mokhtari
Name of organization / entity
Otorhinolaryngology research center, Tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6676 0269
Email address
zmokhtari@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Riluzole on cognitive function of patients with mild Alzheimers disease: a double-blind randomized clinical trial, placebo-controlled
Public title
Effect of Riluzole on Alzheimer's Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having of mild type of Alzheimer's Disease
Receiving one of the anticholinesterase drugs for treating Alzheimer's from three months ago
aged between 60-80
Exclusion criteria:
Having any other type of Dementia
Any history of using Memantine or Riluzole
History of using medications with glutamatergic interaction
History of alcohol and opium abuse
History of diseases such as Parkinson's disease, epilepsy, stroke, high blood pressure, uncontrolled diabetes, MS, mental retardation, CNS tumors, Huntington, subdural Hematoma, history of major psychiatric diseases
History of severe head trauma that results in loss of consciousness
Age
From 60 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by 4 block size.
Blinding (investigator's opinion)
Double blinded
Blinding description
Since the placebo is exactly the same as the original medicine, and when informed consent is informed, the patient is randomly assigned to one of the drug or placebo groups, so the patient is not aware of the type of medication. Also, the main investigator who examined the initial outcome will be blind to patient's drug type, because the allocation is done by Secretary of the clinic.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Vice Chancellor for research, Tehran University of Medical Sciences, Ghods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-02-03, 1396/11/14
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1396.4403
Health conditions studied
1
Description of health condition studied
Alzheimer Disease
ICD-10 code
G30
ICD-10 code description
Alzheimer's disease
Primary outcomes
1
Description
Cognitive function assessment
Timepoint
The first day and the 90th day of study
Method of measurement
Using the test of Mini Mental State Examination (MMSE)
2
Description
Assessment of memory
Timepoint
The first day and the 90th day of study
Method of measurement
Using the test of Delayed recall test
3
Description
Assessment of disease progression
Timepoint
The first day and the 90th day of study
Method of measurement
Using the Functional Assessment Staging Tool (FAST)
Secondary outcomes
1
Description
Drug side effect
Timepoint
fourth week
Method of measurement
ask from patient
Intervention groups
1
Description
Intervention group: Riluzole 50 mg oral tablet twice daily for three months
Category
Treatment - Drugs
2
Description
Control group: Placebo (similar to the original drug) oral twice daily for three months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Dr. Farzad Fatehi
Street address
North Kargar Ave.Shariati hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 84901
Email
zmokhtari@razi.tums.ac.ir
2
Recruitment center
Name of recruitment center
private Clinic of Neurology
Full name of responsible person
Dr.Maryam Norozian
Street address
Shahrak e Gharb .Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8809 4303
Email
zmokhtari@razi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraeian
Street address
Ghods St., Keshavarz Blvd ,Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3628
Email
rcc@tums.ac.ir
Grant name
Grant code / Reference number
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Zahra Mokhtari
Position
PhD of Medical Physiology
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Otorhinolaryngology Research center ,Amiralam hospital ,
City
Tehran
Province
Tehran
Postal code
1145765111
Phone
+98 21 6676 0269
Fax
+98 21 6676 0269
Email
zmokhtari@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Zahra Mokhtari
Position
دکتری تخصصی فیزیولوژی
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Otorhinolaryngology Research center ,Amiralam hospital,North Saadi st.
City
Tehran
Province
Tehran
Postal code
1145765111
Phone
+98 21 6676 0269
Email
zmokhtari@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Zahra Mokhtari
Position
دکتری تخصصی فیزیولوژی پزشکی
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
خیابان سعدی شمالی ،بیمارستان امیراعلم، مرکز تحقیقات گوش و حلق و بینی
City
Tehran
Province
Tehran
Postal code
1145765111
Phone
+98 21 6676 0269
Email
zmokhtari@razi.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available