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IRCT20220614055167N7 IRCT 2025-04-11 Tabriz University of Medical Sciences Evaluating the Safety and Effectiveness of Sodium Pentaborate Pentahydrate for Mild to Moderate Alzheimer’s: A Phase 2 Clinical Trial The Safety and Efficacy of Sodium Pentaborate Pentahydrate in Patients with Mild to Moderate Alzheimer’s Disease: A Randomised, Double-Blind, Placebo-Controlled Phase 2 Trial 2025-04-30 anticipated 60 Complete https://irct.ir/trial/81948 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly assigned to two groups: the first group will receive sodium pentaborate pentahydrate (at a dose of 1000 mg) in combination with donepezil, while the second group will receive donepezil alongside a placebo. To allocate participants to the groups, a balanced block randomisation method at the individual level will be employed. The randomisation sequence will be generated by an independent individual, who is not involved in the study procedures, using RAS (Random Allocation Software). In this process, blocks of four with different arrangements of groups A and B will be used, and allocation will be carried out based on a random number table. The randomisation process in RAS involves the following steps: Defining the intervention group (A) and control group (B) in the software; Setting the block size (blocks of four); Generating all possible allocation combinations within each block (e.g., AABB, ABAB, ABBA, etc.); Randomly selecting blocks using a random number table; Concatenating the selected blocks to create the final allocation sequence. After evaluating the inclusion and exclusion criteria, eligible participants will be enrolled in the study sequentially and assigned to group A or B according to the generated sequence. For example, if the sequence begins with A, B, B, A, the first four participants who meet the criteria and enter the study will be allocated in this order. The allocation process will be concealed, and none of the researchers involved in the study will be aware of the allocation sequence or have the ability to manipulate participant assignment. Only the person responsible for generating the randomisation sequence will have access to it. To ensure blinding, each medication package will be labelled with a unique 10-digit random code. These codes will prevent both the participants and the study investigators from knowing whether the administered treatment is the active drug or the placebo, Blinding description: Both participants and study personnel, including investigators and those responsible for study execution, will remain blinded to treatment allocation until the study is completed. Each active sodium pentaborate pentahydrate treatment group will have a matching placebo group with identical tablets to maintain blinding. Participants will take their assigned medication as a once-daily oral tablet after meals for six months. Study visits are scheduled for screening and randomisation (baseline), as well as at months 1, 2, 4, and 6. 1-2 Mild to Moderate Alzheimer’s Disease. Intervention 1: The intervention group will receive 1000 mg of sodium pentaborate pentahydrate daily (administered as two 500 mg capsules, preferably after lunch and dinner) under the brand name CogniBor (manufactured by APharma), in combination with donepezil, for a duration of six months. Intervention 2: The control group will receive a placebo (administered as two 500 mg capsules, preferably after lunch and dinner) under the brand name CogniBor (manufactured by APharma), in combination with donepezil, for a duration of six months. 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 There is no further information
public Saeid Safiri
Department of Community Medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5157965380 +98 41 3332 7195 saeidsafiri@gmail.com Tabriz University of Medical Sciences scientific Saeid Safiri
Department of Community Medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5157965380 +98 41 3332 7195 saeidsafiri@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Age between 55 and 85 years Diagnosis of mild to moderate Alzheimer’s disease based on the National Institute on Aging and Alzheimer’s Association (NIA-AA) criteria Mini-Mental State Examination (MMSE) score between 10 and 24 Evidence of episodic memory impairment (≥1 standard deviation below age norm) Use of stable doses of Alzheimer’s medications 55 years 85 years Both Presence of major neurological or psychiatric disorders Significant amyloid-related imaging abnormalities (ARIA) detected on magnetic resonance imaging (MRI) Recent use of experimental drugs G30 Alzheimer's disease Treatment - Drugs Treatment - Drugs The intervention group will receive 1000 mg of sodium pentaborate pentahydrate daily (administered as two 500 mg capsules, preferably after lunch and dinner) under the brand name CogniBor (manufactured by APharma), in combination with donepezil, for a duration of six months. The control group will receive a placebo (administered as two 500 mg capsules, preferably after lunch and dinner) under the brand name CogniBor (manufactured by APharma), in combination with donepezil, for a duration of six months. Changes in the Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog13). Timepoint: At baseline (prior to the initiation of the intervention) and six months after the start of the intervention. Method of measurement: Cognitive Subscale (ADAS-Cog13). Changes in the Clinical Dementia Rating – Sum of Boxes (CDR-SB). Timepoint: At baseline (prior to the initiation of the intervention) and six months after the start of the intervention. Method of measurement: Clinical Dementia Rating – Sum of Boxes (CDR-SB). Changes in the Alzheimer’s Disease Cooperative Study – Activities of Daily Living Scale (ADCS-ADL). Timepoint: At baseline (prior to the initiation of the intervention) and six months after the start of the intervention. Method of measurement: Alzheimer’s Disease Cooperative Study – Activities of Daily Living Scale (ADCS-ADL). Tabriz University of Medical Sciences Approved 2025-03-10 Research Ethics Committee of Tabriz University of Medical Sciences Golgasht Street, Tabriz University of Medical Sciences Tabriz East Azarbaijan Iran (Islamic Republic of)