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IRCT20210228050535N8 IRCT 2025-12-06 Mazandaran University of Medical Sciences Exosome therapy for Alzheimer's Investigating the safety and efficacy of engineered exosomes containing BDNF in the treatment of Alzheimer's disease 2026-02-19 anticipated 18 Complete https://irct.ir/trial/86693 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the randomization process was performed as simple randomization at the individual level. In order to control for confounding variables, participants were first stratified by disease severity (mild/moderate) and age group (55–65 and 66–80 years), and then assigned to groups within each stratum using a random list generated in Excel software. To maintain the impartiality of the allocation process, opaque, sealed, and numbered envelopes were used, which were opened only after final confirmation of the patient's entry into the study. Given the nature of the intervention and the necessity of direct clinical supervision of the treatment process, blinding of participants and the treatment team was not performed. 1-2 Alzheimer's. Intervention 1: Intervention group: 50 micrograms of exosomes twice a week for 4 weeks. Intervention 2: Control group: Taking medication from the acetylcholinesterase inhibitor group. 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 Lack of release plan
public Amirali Khodashenas limoni
Department of medical biotechnology, Faculty of Advanced Medical Sciences, Payambar Azam Camplex, Farah Abad Bulvd
Sari Iran (Islamic Republic of) 4817733465 +98 11 3354 3353 s.khodashenas@mazums.ac.ir Mazandaran University of Medical Sciences scientific Amirali Khodashenas limoni
Department of medical biotechnology, Faculty of Advanced Medical Sciences, Payambar Azam Camplex, Farah Abad Bulvd
Sari Iran (Islamic Republic of) 4817733465 +98 11 3354 3353 s.khodashenas@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) • Definite diagnosis of Alzheimer's disease based on DSM-5 criteria and confirmed by brain scans (MRI). • Definite diagnosis of mild or moderate Alzheimer's disease based on NIA/AA (2018) criteria. • Patients must have a low to moderate score (usually between 20 and 35) on the QoL-AD test, which indicates a decrease in quality of life due to the disease. • Patients must have an ADAS-Cog score in the range of early to moderate Alzheimer's disease (usually between 15 and 40). • MMSE score between 10 and 24 (inclusive). • Score less than or equal to 4 on the Modified Hashinsky Ischemic Scale (MHIS). • Age between 55 and 80 years. • Body mass index (BMI) between 18.5 and 30. • Written informed consent obtained from the patient and legal representative or close family before the study began. • The patient's general condition is appropriate based on medical history, physical examination, vital signs, laboratory tests, and electrocardiogram (ECG) results. • Ability to walk independently or with assistive devices (such as a wheelchair, walker, or cane) and no vision or hearing problems that would prevent them from following the study (using glasses or hearing aids is permitted). • Presence of a designated and reliable caregiver who meets the following requirements: o Ability to read and understand research-related documents and communicate with the investigator. o Ability to follow research instructions and provide accurate information about the patient's condition during the study. o Living with the patient or providing care at least 3 days a week and at least 2 hours a day. 55 years 80 years Both • Non-cooperation during the study. • Serious treatment-related adverse events. • Active infectious diseases or autoimmune disorders. • Severe hypersensitivity to therapeutic compounds. • Receiving treatment with mesenchymal stem cells or their derived exosomes. • The following laboratory results: o Neutrophil count less than 100 × 10⁹/L o Platelet count less than 100 × 10⁹/L o Serum albumin level less than 30 g/L. o Serum creatinine level above the normal range. o Total bilirubin, ALT, and AST levels greater than twice the upper limit of normal. • Underlying medical conditions, including (but not limited to) cardiovascular, cerebrovascular, hepatic, renal, pulmonary, or endocrine diseases. • Severe Alzheimer’s. (Score less than 10 on MMSE and MoCA questionnaires) • Severe depression (score greater than 29 on standard questionnaires such as Beck Depression Inventory (BDI-II) or score 24–35 on the 24-item version of the Hamilton Depression Scale (HAM-D)). • Having diseases such as Parkinson's, vascular dementia, Huntington's, hydrocephalus, progressive supranuclear palsy, multiple sclerosis, epilepsy, mental retardation, or a significant history of brain injury. • Having a history of malignant neoplasm. • Contraindications to MRI for reasons such as the presence of implanted electronic devices, agoraphobia, or critical condition. • Positive results for HIV, HBV, HCV, and syphilis. • Participation in another clinical study in the past 6 months. • Pregnancy, breastfeeding, or pregnancy in the past 6 months. • Any other conditions that the investigator deems inappropriate, including factors that reduce compliance with follow-up. G30.0 Alzheimer's disease with early onset Treatment - Other Treatment - Drugs Intervention group: 50 micrograms of exosomes twice a week for 4 weeks. Control group: Taking medication from the acetylcholinesterase inhibitor group. Quality of life of Alzheimer’s patients. Timepoint: Three to six months after the last injection, on a monthly basis. Method of measurement: Using the QoL-AD, ADAS-Cog, and MMSE questionnaires. Amyloid plaques in the brains of Alzheimer’s patients. Timepoint: Before the injection and three months after the last injection. Method of measurement: MRI. Evaluation of the safety of BDNF-containing exosome injections. Timepoint: Three days after each injection. Method of measurement: The changes in TNF-α and IL-6 levels, as well as liver enzyme tests and BUN, using ELISA and biochemical assays. Mazandaran University of Medical Sciences Approved 2025-10-29 Research Ethics Committee of Mazandaran University of Medical Scienc Deputy of research and technology. Moallem sq., Sari Sari Mazandaran Iran (Islamic Republic of)