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
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)
研究概览
简要总结
Alzheimer's disease (AD) is the leading cause of dementia, affecting millions worldwide. With its global prevalence steadily increasing, particularly in low- and middle-income countries, the demand for effective treatments has become critical. Despite significant advancements in understanding AD pathophysiology, including amyloid-beta plaques and tau tangles, no disease-modifying therapies are currently available, highlighting the urgent need for novel therapeutic interventions.
This proposal presents a Phase 2, randomised, double-blind, placebo-controlled trial to assess the safety and efficacy of sodium pentaborate pentahydrate (NaB) in patients with mild to moderate AD. A total of 60 participants aged 55 to 85 years with confirmed AD will be randomly assigned to receive either NaB (1000 mg) or a placebo, alongside Donepezil, for six months. The primary outcome will be changes in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13), while secondary outcomes will include the Clinical Dementia Rating-Sum of Boxes (CDR-SB) and the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL).
详细描述
This study is a Phase 2, randomised, double-blind, placebo-controlled trial conducted over six months to evaluate the safety and efficacy of sodium pentaborate pentahydrate in patients with Alzheimer's disease. Participants will be screened and enrolled in the study under the principles of the Declaration of Helsinki, International Conference on Harmonisation (ICH) guidelines, and local regulatory requirements. Written informed consent will be obtained from all participants or their legal representatives.
Study Design and Participants
Participants aged 55 to 85 years with mild to moderate Alzheimer's disease will be recruited based on the criteria of the National Institute on Aging and the Alzheimer's Association (NIA-AA). Screening methods will include a Mini-Mental State Examination (MMSE) score between 10 and 24, evidence of episodic memory impairment (≥1 standard deviation below the age norm), and the use of stable doses of Alzheimer's medications. Exclusion criteria include major neurological or psychiatric disorders, significant amyloid-related imaging abnormalities (ARIA) detected on magnetic resonance imaging (MRI), or recent use of experimental drugs.
Randomisation and Intervention
Participants will be randomly assigned to two groups: one group will receive a placebo along with donepezil, while the other group will receive 1000 mg of sodium pentaborate pentahydrate daily along with donepezil. A balanced block randomisation method will be used to allocate participants into the two groups. The randomisation sequence will be generated by an independent individual uninvolved in the study to minimise the risk of prediction or manipulation and to ensure balanced group sizes throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
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.
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Presence of major neurological or psychiatric disorders Significant amyloid-related imaging abnormalities (ARIA) detected on magnetic resonance imaging (MRI) Recent use of experimental drugs
研究组 & 干预措施
Intervention
will receive 1000 mg of sodium pentaborate pentahydrate daily along with donepezil
干预措施: Sodium Pentaborate Pentahydrate (Drug)
Placebo
will receive a placebo along with donepezil
干预措施: Placebo (Drug)
结局指标
主要结局
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)
时间窗: Baseline to month 6
The primary outcome will be changes in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) score, ranging from 0 to 85, where higher scores indicate greater impairment from baseline to month 6.
次要结局
- Clinical Dementia Rating - Sum of Boxes (CDR-SB)(Baseline to month 6)
- Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS-ADL)(Baseline to month 6.)
研究者
Dr. Saeid Safiri
Dr
Tabriz University of Medical Sciences