Evaluating the Safety and Effectiveness of Sodium Pentaborate Pentahydrate for Mild to Moderate Alzheimer’s: A Phase 2 Clinical Trial

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220614055167N7

Enrollment

Registered

2025-04-11

Start date

2025-04-30

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild to Moderate Alzheimer’s Disease. Alzheimers disease

Interventions

Intervention 1: The intervention group will receive 1000 mg of sodium pentaborate pentahydrate daily (administered as two 500 mg capsules, preferably after lunch and dinner) under the brand name Cogni

Eligibility

Sex/Gender

All

Age

55 Years to 85 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Changes in the Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog13). Timepoint: At baseline (prior to the initiation of the intervention) and six months after the start of the intervention. Method of measurement: Cognitive Subscale (ADAS-Cog13).	—

Secondary

Measure	Time frame
Changes in the Clinical Dementia Rating – Sum of Boxes (CDR-SB). Timepoint: At baseline (prior to the initiation of the intervention) and six months after the start of the intervention. Method of measurement: Clinical Dementia Rating – Sum of Boxes (CDR-SB).;Changes in the Alzheimer’s Disease Cooperative Study – Activities of Daily Living Scale (ADCS-ADL). Timepoint: At baseline (prior to the initiation of the intervention) and six months after the start of the intervention. Method of measurement: Alzheimer’s Disease Cooperative Study – Activities of Daily Living Scale (ADCS-ADL).	—

Measure

Time frame

Changes in the Clinical Dementia Rating – Sum of Boxes (CDR-SB). Timepoint: At baseline (prior to the initiation of the intervention) and six months after the start of the intervention. Method of measurement: Clinical Dementia Rating – Sum of Boxes (CDR-SB).;Changes in the Alzheimer’s Disease Cooperative Study – Activities of Daily Living Scale (ADCS-ADL). Timepoint: At baseline (prior to the initiation of the intervention) and six months after the start of the intervention. Method of measurement: Alzheimer’s Disease Cooperative Study – Activities of Daily Living Scale (ADCS-ADL).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaeid Safiri

Tabriz University of Medical Sciences

saeidsafiri@gmail.com+98 41 3332 7195

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026