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IRCT20130829014521N15 IRCT 2020-03-01 Mashhad University of Medical Sciences Trehalose and Alzheimer disease Mycose AdminiStration for HealIng Alzheimer NEuropathy (MASHIANE) Evaluation of the therapeutic effects of trehalose in patients with Alzheimer disease 2020-06-20 anticipated 10 Complete https://irct.ir/trial/45320 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 2 Alzheimer disease. Intervention 1: Intervention group: Trehalose will be administrated intravenously (15 g/week) for 12 weeks in the intervention group. Intervention 2: Control group: Normal saline as a placebo will be administrated intravenously for 12 weeks in the control group. No - There is not a plan to make this available Justification or reason for not sharing IPD is "There is no further information"
public Amirhossein Sahebkar
School of Pharmacy, East door of Ferdowsi University, Azadi Square, Mashhad
Mashhad Iran (Islamic Republic of) 9177899191 +98 51 1882 9260 sahebkara@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Amirhossein Sahebkar
Biotechnology Department, School of pharmacy, East door of Ferdowsi University, Azadi square, Mashhad
Mashhad Iran (Islamic Republic of) 9177899191 +98 51 1800 2288 sahebkara@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Mini-Mental State Examination (MMSE) score range from 10 to 23 Not having other cognitive disorders no limit no limit Both 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 G30. 9 Dementia in Alzheimer's disease, atypical or mixed type Treatment - Drugs Placebo Intervention group: Trehalose will be administrated intravenously (15 g/week) for 12 weeks in the intervention group. Control group: Normal saline as a placebo will be administrated intravenously for 12 weeks in the control group. 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. Alterations in Alzheimer disease-related microRNA levels. Timepoint: Baseline and week 12. Method of measurement: Real-time quantitative PCR. Alteration in serum levels of phosphorylated tau protein. Timepoint: Baseline and week 12. Method of measurement: ELISA. Alteration in serum levels of Aβ42. Timepoint: Baseline and week 12. Method of measurement: ELISA. Mashhad University of Medical Sciences Approved 2019-05-21 Ethics Committee of Mashhad University of Medical Sciences Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street. Mashhad Razavi Khorasan Iran (Islamic Republic of)