To assess the effect of trehalose on cognitive abillity in patients with Lewy body dementia and evaluation of key proteins in the protein interaction network of LBD
The aim of this study is to conduct a clinical trial of oral trehalose in people with Lewy body dementia and to find the mechanism of effectiveness of trehalose in these people using expression data of normal brain tissues and tissues of people with dementia with Lewy bodies using the network modeling method in systems biology.
Design
A controlled, triple-blind, randomized, phase 2 clinical trial on 60 patients.
Settings and conduct
Patients with Lewy body dementia with mentioned inclusion criteria, will be enrolled to this study after informed consent. By random allocation, they will be divided into intervention (trehalose) and placebo group. The duration of intervention will be 3 months. After the duration of intervention, the two groups will be compares for mentioned outcomes. It should be noted that as the products are similar in shape and color, the participants will be blinded to study groups. Moreover, as the treatment groups will be written in A/B codes in datasheets and in SPSS software, both the assessor and the analyzer will be blinded to study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Individuals with Lewy body dementia who consent to participate in the study.
Exclusion criteria: Suffering from atypical parkinsonism syndromes and Alzheimer's or other neurodegenerative diseases
Intervention groups
Trehalose intervention group will be administered 20 grams orally per day for up to three months;
Placebo (sucrose) control group will be administered 20 grams orally per day.
Main outcome variables
Primary Outcome: In order to assess the cognitive impairment, the MMSE and MOCA tests will be performed at baseline and evaluated at the twelfth week of study.
Secondary Outcome: Serum level of alpha-synuclein.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250317065107N1
Registration date:2025-05-11, 1404/02/21
Registration timing:prospective
Last update:2025-05-11, 1404/02/21
Update count:0
Registration date
2025-05-11, 1404/02/21
Registrant information
Name
Seyed Hamid Aghaee Bakhtiari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2300
Email address
aghaeibh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-05-22, 1404/03/01
Expected recruitment end date
2026-09-22, 1405/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To assess the effect of trehalose on cognitive abillity in patients with Lewy body dementia and evaluation of key proteins in the protein interaction network of LBD
Public title
Assessment the effect of trehalose in patients with Lewy body dementia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals with Lewy body dementia
Individuals must consent to participate in the study
Exclusion criteria:
Having atypical parkinsonism syndromes
Having Alzheimer
Having other neurodegenerative diseases
Age
From 35 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are randomly assigned to two groups: intervention and control using randomized blocks of 2 and 4 (using sealedenvelope.com). After randomization, the type of treatment is written in A/B codes in separate papers and placed in an opaque envelope or the paper will wrap so that no one can see inside the paper (random concealment). After obtaining informed consent from the participants, one paper will be taken in order and according to the noted code, the patient is place in one of the intervention or placebo groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
As mentioned before, after randomization, the patients place in groups of A/B and received the products similar in shape and color (blinding of participants). The information of the patients and theirs treatment groups will be written with randomized codes (A/B) on datasheets (the blinding of the assessor). Data will be entered to the SPSS software with codes (the blinding of the analyzer).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Mashhad University of Medical Sciences
Street address
Ghoreshi Building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2025-01-22, 1403/11/03
Ethics committee reference number
IR.MUMS.REC.1403.381
Health conditions studied
1
Description of health condition studied
Lewy body dementia
ICD-10 code
G31.83
ICD-10 code description
Dementia with Lewy bodies
Primary outcomes
1
Description
Cognitive impairment
Timepoint
Evaluation is done at the beginning of the study and at the twelfth week.
Method of measurement
Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) will be used for cognitive assessment.
Secondary outcomes
1
Description
Serum level of α-Synuclein
Timepoint
At baseline and after 12 weeks from intervention
Method of measurement
ELISA
Intervention groups
1
Description
Intervention group: Trehalose (Shanxxi Fruiterco Co. Ltd. China) will be administered orally at a dose of 20 grams per day for up to three months.
Category
Treatment - Drugs
2
Description
Control group: Placebo (sucrose) will be administered 20 grams orally per day for three months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology Department, Ghaem Hospital
Full name of responsible person
Ali Shoeibi
Street address
Office of the Neurology Department, Ghaem Hospital, Ahmadabad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9919991766
Phone
+98 51 3840 0001
Email
b.ghaem@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
University Street - Next to Hoveyzeh Cinema - Qorashi Building - Vice President for Research and Technology
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresearch@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
Khadijeh Del Azad
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Medical Biotechnology
Street address
Department of Medical Biotechnology and Nanotechnology, Faculty of Medicine, Mashhad University of Medical Sciences, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
009 51 38002288
Email
DelAzadK4001@mums.ac.i
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Hamid Aghaee Bakhtiari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Department of Medical Biotechnology and Nanotechnology, Faculty of Medicine, Mashhad University Of Medical Sciences, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2300
Fax
Email
aghaeibh@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Khadijeh Del Azad
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Medical Biotechnology
Street address
Department of Medical Biotechnology and Nanotechnology, Faculty of Medicine, Mashhad University of Medical Sciences, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
009 51 38002288
Email
DelAzadK4001@mums.ac.i
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