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IRCT20260625069941N1 IRCT 2026-07-20 Mashhad University of Medical Sciences Investigation the effects of Trehalose in cognitive impairment in the elderly Investigation of the therapeutic effects of Intravenous Trehalose in mild cognitive impairment in the elderly 2026-08-06 anticipated 34 Recruiting https://irct.ir/trial/91390 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization will be conducted using the block sizes of 2 and 4 with randomization websites such as sealedenvelope.com. After randomization, the type of treatment will be written with odds and even numbers (or A/B codes) in separate papers and placed in an opaque envelope or the paper will be wrapped so that no one can see inside the paper (allocation concealment). After obtaining informed consent from the participants, one paper will be taken in order and according to the noted code, the participants will be placed in one of the intervention or placebo groups, Blinding description: After randomization, the patients will be placed in two groups of A/B (or odds/even codes) and will receive the products similar in shape and color (blinding of participants). The physician who will give the products to participants, receive the boxes of the products with randomized codes (so the physician will be blind too). The information of the patients and theirs treatment groups will be written with randomized codes (A/B) (blinding of the assessor). Data will be entered to the SPSS software with codes (blinding of the analyzer). It should be noted that Data and Safety Monitoring Board (DSMB) will be blinded too. 1-2 Mild Cognitive Impairment. Intervention 1: Intervention group: Intravenous (IV) Trehalose (15 g per week) for 12 weeks by Dr.Rajabi Pharmaceutical company. Intervention 2: Control group: Intravenous (IV) Normal Salin per week for 12 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is This project will be conducted between the Medical faculty and School of Pharmacy and it is an interdisciplinary project. The consensus of all research team members regarding this matter is required; therefore, a final decision will be reached at a later stage.
public Zanireh Salimi
Ebnesina Hospital.,Horeameli Ave.,Toos Blvd.
Mashhad Iran (Islamic Republic of) 9195983117 +98 51 3712 7017 salimizn@mums.ac.ir Mashhad University of Medical Sciences scientific Zanireh Salimi
Ebnesina Hospital.,Horeameli Ave.,Toos Blvd.
Mashhad Iran (Islamic Republic of) 9195983117 +98 51 3712 7017 salimizn@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Diagnosis of mild cognitive impairment by a neuropsychiatrist Age between 60 to 90 In case of using Donpezil or Rivastigmin, at least 3 months should be passed MOCA between 18 and 26 60 years 90 years Both Major depressive disorder Significant psychologic disorders Drug abuse Previous history of renal or liver failure G31.84 Mild cognitive impairment, so stated Treatment - Drugs Placebo Intervention group: Intravenous (IV) Trehalose (15 g per week) for 12 weeks by Dr.Rajabi Pharmaceutical company Control group: Intravenous (IV) Normal Salin per week for 12 weeks Assessment of Cognition by Mini-Mental State Examination (MMSE). Timepoint: At baseline and after 12 weeks. Method of measurement: MMSE Questionnaire (This questionnaire consists questions about orientation, registration, attention and calculation, recall, language and praxis. The total score is 30.). Assessment of Cognition by Montreal Cognitive Assessment (MOCA). Timepoint: At baseline and after 12 weeks. Method of measurement: MOCA questionnaire (An interviewer is present during the completion of the questionnaire to provide guidance and clarify specific items. MOCA cosists some parts including Visuospatial/executive, Naming, Memory, Attention, Language, Abstraction, Delayed recall, and Orientation). Fasting Blood Glucose (FBG). Timepoint: At baseline and after 12 weeks. Method of measurement: Blood sample. Electrolytes (Sodium and Potassium). Timepoint: At baseline and after 12 weeks. Method of measurement: Blood sample. Mashhad University of Medical Sciences Approved 2026-05-23 Research Ethics Committee of Mashhad University of Medical Sciences Dr.Kharazmi Educational Building, University Campus, Azadi Square Mashhad Razavi Khorasan Iran (Islamic Republic of)