Impact of NANO-PSO on Cognition in Older Adults with Mild to Moderate Cognitive Impairment
Impact of NANO-PSO (omega 5) Supplementation on Cognitive Abilities of Older Adults with Mild to Moderate Non-vascular Cognitive Impairment
Distribuidora Biolife SA de CV
60 participants
Feb 12, 2025
INTERVENTIONAL
Conditions
Summary
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 patient or primary caregiver must maintain a log to confirm daily dose consumption and will have a direct communication line with the attending physicians in case of questions about ingestion or possible adverse reactions. * At the end of the final patient evaluation, a quality questionnaire will be administered.
Eligibility
Inclusion Criteria10
- 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 Criteria4
- 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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Interventions
NANO-PSO administered orally, 2 capsules, equivalent to 640 mg of pomegranate seed oil, every 24 hours in the morning with food.
Placebo administered orally, 2 capsules, equivalent to 640 mg of mineral oil, every 24 hours in the morning with food.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06520878