NCT06840054Not yet recruitingPhase 2
The Safety and Efficacy of Sodium Pentaborate Pentahydrate in Patients With Mild to Moderate Alzheimer's Disease
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
Source: ClinicalTrials.gov · Last updated 21 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 17 Feb 2025
- Start date
- 1 May 2025
- Primary completion date
- 30 Jan 2026
- Lead sponsor
- Tabriz University of Medical Sciences
- Diseases
- Alzheimer disease
- NCT number
- NCT06840054
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 1 May 2025 to the primary completion date, 30 Jan 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Presence of major neurological or psychiatric disorders Significant amyloid-related imaging abnormalities (ARIA) detected on magnetic resonance imaging (MRI) Recent use of experimental drugs
Who the study is looking for
- 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
Age in the registry: 55 years to 85 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.