Health TrialsbyHealthPanel

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

ConditionAlzheimer Disease
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age55-85
SponsorTabriz University of Medical Sciences

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sodium Pentaborate Pentahydrate

    Drug

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

  • Placebo

    Drug

    will receive a placebo along with donepezil

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
Baseline to month 6

Secondary outcomes

1

Clinical Dementia Rating - Sum of Boxes (CDR-SB)

Changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score, ranging from 0 to 18, where higher scores indicate greater impairment.

Time frame
Baseline to month 6
2

Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS-ADL)

Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) score, ranging from 0 to 78, where lower scores indicate greater impairment.

Time frame
Baseline to month 6.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tabriz University of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: