Status:
RECRUITING
Impact of NANO-PSO on Cognition in Older Adults with Mild to Moderate Cognitive Impairment
Lead Sponsor:
Distribuidora Biolife SA de CV
Conditions:
Cognition
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06520878
Start Date
February 12 2025
End Date
December 1 2025
Last Update
February 6 2025
Active Locations (1)
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1
Hospital Español. Av Ejercito Nacional 613, Miguel Hidalgo, CDMX, 11520
Miguel Hidalgo, Mexico City, Mexico, 11520