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Recruiting NCT06520878

Impact of NANO-PSO on Cognition in Older Adults with Mild to Moderate Cognitive Impairment

Phase II Interventional Cognition

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NANO-PSO (pomegranate seed oil), Placebo.
Who it may be relevant to
Registry conditions: Cognition. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Mexico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Impact of NANO-PSO (omega 5) Supplementation on Cognitive Abilities of Older Adults with Mild to Moderate Non-vascular Cognitive Impairment

Overview

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.

Interventions

  • Dietary supplement NANO-PSO (pomegranate seed oil)
    NANO-PSO administered orally, 2 capsules, equivalent to 640 mg of pomegranate seed oil, every 24 hours in the morning with food.
  • Dietary supplement Placebo
    Placebo administered orally, 2 capsules, equivalent to 640 mg of mineral oil, every 24 hours in the morning with food.

Primary outcome measures

  • Cognitive status assessment [Time frame: Assessed at baseline, 3, and 6 months.]
Secondary outcome measures (3)
  • Patients' fatigue status [Time frame: Assessed at baseline, 3, and 6 months.]
  • Selective attention and processing speed [Time frame: Assessed at baseline, 3, and 6 months.]
  • Frailty [Time frame: Assessed at baseline, 3, and 6 months.]

Eligibility criteria

Inclusion 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.
  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Mexico · 1 center
  • Hospital Español. Av Ejercito Nacional 613, Miguel Hidalgo, CDMX, 11520 — Miguel Hidalgo

Publications

  • Binyamin O, Nitzan K, Frid K, Ungar Y, Rosenmann H, Gabizon R. Brain targeting of 9c,11t-Conjugated Linoleic Acid, a natural calpain inhibitor, preserves memory and reduces Abeta and P25 accumulation in 5XFAD mice. Sci Rep. 2019 Dec 5;9(1):18437. doi: 10.1038/s41598-019-54971-9. PMID 31804596

Identifiers

NCT: NCT06520878 · ENS-2024-TL001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗