Actively Recruiting
Impact of NANO-PSO on Cognition in Older Adults with Mild to Moderate Cognitive Impairment
Led by Distribuidora Biolife SA de CV · Updated on 2025-02-06
60
Participants Needed
1
Research Sites
41 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Impact of NANO-PSO on Cognition in Older Adults with Mild to Moderate Cognitive Impairment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Español. Av Ejercito Nacional 613, Miguel Hidalgo, CDMX, 11520
Miguel Hidalgo, Mexico City, Mexico, 11520
Actively Recruiting
Research Team
A
Alejandro Padilla Isassi, Geriatrician and researcher
CONTACT
A
Abraham Samra Saad, Geriatrician and researcher
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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