NANO-PSO therapy for improving cognition in older adults with cognitive impairment

Impact of NANO-PSO (omega 5) Supplementation on Cognitive Abilities of Older Adults with Mild to Moderate Non-vascular Cognitive Impairment

This study is testing if a pomegranate seed oil supplement can help older adults with mild to moderate cognitive impairment think better over six months.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Distribuidora Biolife SA de CV (Industry-sponsored)
• Locations: 1 site (Miguel Hidalgo, Mexico City)
• Trial ID: NCT06520878 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of NANO-PSO, a pomegranate seed oil supplement, in enhancing cognitive abilities among older adults aged 60 and above who have mild to moderate non-vascular cognitive impairment. Participants will be randomly assigned to receive either NANO-PSO or a placebo for six months, with monthly phone evaluations and in-person assessments at 90 and 180 days to monitor progress and adherence. The study aims to determine if NANO-PSO can significantly improve cognitive function compared to a placebo.

Who should consider this trial

Good fit: Ideal candidates are older adults aged 60 and above with mild to moderate cognitive impairment who meet specific diagnostic criteria for probable dementia.

Not a fit: Patients with severe cognitive impairment or those not meeting the inclusion criteria for dementia may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new, non-invasive option for improving cognitive function in older adults with cognitive impairment.

How similar studies have performed: While there have been studies on cognitive enhancement supplements, the specific use of NANO-PSO in this context is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Patients attended at the Hospital Español.
* Patients of any gender who are 60 years or older.
* Patients presenting with mild to moderate cognitive impairment.
* Meet the diagnostic criteria for \"probable dementia\" of the National Institute on Aging and the Alzheimer's Association (NIA-AA) (2011).
* Meet the criteria for the typical variant of Alzheimer's disease, specifically a specific clinical phenotype.
* Progressive and gradual change in memory functions reported by the patient or the informant for at least 6 months.
* Objective evidence of a hippocampal-type amnesic syndrome, based on significant impairment in the performance of episodic memory tests with established specificity for AD.
* Subjects are primary and secondary school graduates and have the ability to complete cognitive capacity tests and other specified tests in the program.
* Total score on the Hachinski Ischemic Scale (HIS) ≤ 4.
* Patients who sign the informed consent.

Exclusion Criteria:

* Patients with known allergy to any component of the NANO-PSO capsule (e.g., fish).
* Patients with short bowel syndrome, bariatric surgery, or gluten reaction that may affect intestinal absorption.
* Patients in palliative care with a life expectancy of less than 6 months according to the NECPAL scale.
* Patients with terminality criteria established in the comprehensive palliative care management guide of Mexico.

Where this trial is running

Miguel Hidalgo, Mexico City

• Hospital Español. Av Ejercito Nacional 613, Miguel Hidalgo, CDMX, 11520 — Miguel Hidalgo, Mexico City, Mexico (Recruiting)

Study contacts

• Principal investigator: Alejandro Padilla Isassi, Geriatrician and researcher — Distribuidora Biolife S.A. de C.V.
• Study coordinator: Alejandro Padilla Isassi, Geriatrician and researcher

Conditions Cognition; NANO-PSO; Omega 5; Supplementation; Cognitive impairment; Antioxidants