Investigation of the therapeutic effects of Intravenous Trehalose in mild cognitive impairment in the elderly

Investigation of the therapeutic effects of Intravenous Trehalose in mild cognitive impairment in the elderly

Triple-blind parallel randomized clinical trial with control group, on 34 patients. (It should be noted that the participants, investigator, assessor, analyzer and Data and Safety Monitoring Board (DSMB) will be blinded to study groups.)

Elderly patients with mild cognitive disorder who will refer to psychiatrist in Ghaem/Ebnesina Hospitals or in private clinics in Mashhad, and meet the inclusion criteria, will be enrolled to this study after informed consent. They will be divided randomly into two groups of intervention (trehalose) and control (placebo). The study period will take 3 months. The mentioned outcomes will be assessed and compared between two groups at baseline and after 3 months.

Inclusion Criteria: Elderly with mild cognitive impairment (diagnosed by neuropsychiatrist), Age between 60 and 90, MOCA between 18 to 26, In case of using Donpezil or Rivastigmin, at least 3 months should be passed. Exclusion Criteria: Drug abuse, History of liver or renal failure, Major Depressive Disorder (MDD), Significant psychiatric disorders.

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

Primary Outcomes: Mini-mental State Examination (MMSE) and Montreal Cognitive Assessment (MOCA). Secondary Outcomes: Fasting Blood Glucose (FBG), Electrolytes levels in serum (sodium, potassium).

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.

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.