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New treatment option for Cognition
Official title Impact of NANO-PSO on Cognition in Older Adults with Mild to Moderate Cognitive Impairment
ClinicalTrials.gov ID: NCT06520878
What this study is testing
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join 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.
You likely can't join 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.
See the full eligibility 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.
- people 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.
- 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 study team makes the final eligibility decision.
Where it's taking place
- Miguel Hidalgo, Mexico City, Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miguel Hidalgo, Mexico City, Mexico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.