The aim of this study was to determin the effectiveness of trehalose on reducing the symptoms in AD patients.
Design
This study has been designed as pilot randomized, ،triple-blind, placebo-controlled and parallel trial.
Settings and conduct
Patients will be selected from Ibn Sina Hospital and they randomized to receive trehalose or normal saline as a placebo for 12 weeks. Participants, care providers, investigators, and outcome assessors, will be kept unaware of the treatment administered.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with probable Alzheimer disease with Mini-Mental State Examination (MMSE) score range from 10 to 23 and Not having other cognitive disorders.
Exclusion Criteria: MMSE score higher than 23 or lower than 10, The presence of other cognitive disorders which will be evaluated by clinical assessment and brain imaging, Vascular dementia and Lewy body dementia, Previous history of head trauma, Use of alcohol and other drugs that affect cognitive functioning.
Intervention groups
Twenty patients with Alzheimer randomly will be divided into an intervention and a control group. Trehalose will be administrated intravenously (15 g/week) for 12 weeks in the intervention group and the control group will be received normal saline as a placebo.
Main outcome variables
Changes in cognition status, which will be assessed with Clinical Dementia Rating (CDR) and MMSE tests.
General information
Reason for update
Acronym
Mycose AdminiStration for HealIng Alzheimer NEuropathy (MASHIANE)
IRCT registration information
IRCT registration number:IRCT20130829014521N15
Registration date:2020-03-01, 1398/12/11
Registration timing:prospective
Last update:2020-03-01, 1398/12/11
Update count:0
Registration date
2020-03-01, 1398/12/11
Registrant information
Name
Amirhossein Sahebkar
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1882 9260
Email address
sahebkara@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-20, 1399/03/31
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the therapeutic effects of trehalose in patients with Alzheimer disease
Public title
Trehalose and Alzheimer disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mini-Mental State Examination (MMSE) score range from 10 to 23
Not having other cognitive disorders
Exclusion criteria:
MMSE score higher than 23 or lower than 10
The presence of other cognitive disorders which will be evaluated by clinical assessment and brain imaging
Vascular dementia and Lewy body dementia
Previous history of head trauma
Use of alcohol and other drugs that affect cognitive functioning
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
This study has been designed as pilot randomized, triple-blind, placebo-controlled and parallel trial. Simple randomization for allocation and sealed envelope approach would be considered for concealed allocation.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study has been designed as triple-blind and persons including participants, care providers, investigators, and outcome assessors, keeping unaware of the treatment administered. Drug and placebo vials have similar packaging and labeling and all recorded data will be encoded in the questionnaires and software.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2019-05-21, 1398/02/31
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.333
Health conditions studied
1
Description of health condition studied
Alzheimer disease
ICD-10 code
G30. 9
ICD-10 code description
Dementia in Alzheimer's disease, atypical or mixed type
Primary outcomes
1
Description
Change in CDR-SB and MMSE scores
Timepoint
At the beginning and end of the intervention trial (Day 0 and week 12)
Method of measurement
Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) and Mini-Mental State Examination (MMSE) questionnaire
Secondary outcomes
1
Description
Alterations in Alzheimer disease-related microRNA levels
Timepoint
Baseline and week 12
Method of measurement
Real-time quantitative PCR
2
Description
Alteration in serum levels of phosphorylated tau protein
Timepoint
Baseline and week 12
Method of measurement
ELISA
3
Description
Alteration in serum levels of Aβ42
Timepoint
Baseline and week 12
Method of measurement
ELISA
Intervention groups
1
Description
Intervention group: Trehalose will be administrated intravenously (15 g/week) for 12 weeks in the intervention group.
Category
Treatment - Drugs
2
Description
Control group: Normal saline as a placebo will be administrated intravenously for 12 weeks in the control group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ebnesina hospital
Full name of responsible person
Amirhossein Sahebkar
Street address
Ebnesina hospital, Horr Ameli Blvd., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Phone
+98 51 3180 1000
Email
Sahebkara@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Vice-Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street, Mashhad,
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Amirhossein Sahebkar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmaceutical biotechnology
Street address
School of Pharmacy, East door of Ferdowsi University, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 1882 9260
Fax
+98 51 1882 3251
Email
sahebkara@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Amirhossein Sahebkar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmaceutical Biotechnology
Street address
Biotechnology Department, School of pharmacy, East door of Ferdowsi University, Azadi square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 1800 2288
Fax
Email
sahebkara@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Amirhossein Sahebkar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
pharmaceutical biotechnology
Street address
School of Medicine, East door of Ferdowsi University, Azadi square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 1800 2288
Fax
Email
sahebkara@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD