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Impact of NANO-PSO on Cognition in Older Adults with Mild to Moderate Cognitive Impairment

RecruitingPhase 2Ages 60 Years - anyAllDistribuidora Biolife SA de CV
NCT06520878 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The objective of this randomized, triple-blind, placebo-controlled clinical trial is to compare NANO-PSO therapy against placebo in improving cognitive abilities in older adults with mild to moderate non-vascular cognitive impairment over six months of treatment. The primary questions it aims to answer are: • Does NANO-PSO therapy improve cognitive abilities in older adults with mild to moderate non-vascular cognitive impairment over six months of treatment compared to placebo? The researchers will compare NANO-PSO therapy against placebo to see if it benefits the cognitive abilities of geriatric patients. Participants will be required to: * Consume two capsules of NANO-PSO or placebo daily in the morning for six months. * Be evaluated monthly by phone to identify potential risks and ensure adherence to the treatment. * Be evaluated in person at 90 and 180 days of treatment. * The pa

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📋 Eligibility rules (as published)
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.
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What it tests

  • NANO-PSO (pomegranate seed oil)
  • Placebo
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Where

1 site
Hospital Español. Av Ejercito Nacional 613, Miguel Hidalgo, CDMX, 11520
Miguel Hidalgo, Mexico
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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