Clinical Research Directory

The Safety and Efficacy of Sodium Pentaborate Pentahydrate in Patients With Mild to Moderate Alzheimer's Disease

Sponsor: Tabriz University of Medical Sciences

Summary

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).

Official title: 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

Key Details

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Interventions