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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: alejandropadillaisassi@gmail.com
• Phone: +525589510727

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.