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

NCT06840054 | Not Yet Recruiting Phase 2

• 1 other identifier: 75883
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Alzheimer Disease

Keywords

Alzheimer Disease; Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)

  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.

  Baseline to month 6

Secondary Outcomes (2)

• 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.

Study Arms (2)

Intervention

EXPERIMENTAL

will receive 1000 mg of sodium pentaborate pentahydrate daily along with donepezil

Drug: Sodium Pentaborate Pentahydrate

Placebo

PLACEBO COMPARATOR

will receive a placebo along with donepezil

Drug: Placebo

Interventions

Sodium Pentaborate Pentahydrate DRUG

will receive 1000 mg of sodium pentaborate pentahydrate daily along with donepezil.

Intervention

Placebo DRUG

will receive a placebo along with donepezil

Placebo

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Presence of major neurological or psychiatric disorders Significant amyloid-related imaging abnormalities (ARIA) detected on magnetic resonance imaging (MRI) Recent use of experimental drugs

Sponsors & Collaborators

• Tabriz University of Medical Sciences: lead

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Saeid Safiri, PhD

CONTACT

00989141005277; saeidsafiri@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 21, 2025
• Study Start: May 1, 2025
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: February 21, 2025

Record last verified: 2025-02