NCT06520878 · Phase 2 · RECRUITING
Impact of NANO-PSO on Cognition in Older Adults with Mild to Moderate Cognitive Impairment
This trial is testing NANO-PSO, a pomegranate seed oil supplement, to see whether it improves memory and thinking in older adults who already have mild to moderate cognitive impairment consistent with Alzheimer's disease. Participants take two capsules daily for six months, then researchers compare results against a placebo group. This is a Phase 2 trial, meaning researchers are testing whether it shows a meaningful effect and is safe — it is not yet proven or approved.
You may qualify if
- 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.
You're excluded if
- 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-02-06