Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06520878

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cognition Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Español. Av Ejercito Nacional 613, Miguel Hidalgo, CDMX, 11520

Miguel Hidalgo, Mexico City, 11520, Mexico

Location status: Recruiting

Location contact

Alejandro Padilla Isassi, Geriatrician

CONTACT

[email protected]

5625592234

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NANO-PSO (pomegranate seed oil)

Dietary Supplement

NANO-PSO administered orally, 2 capsules, equivalent to 640 mg of pomegranate seed oil, every 24 hours in the morning with food.

Other names: Granagard, Omega 5

Placebo

Dietary Supplement

Placebo administered orally, 2 capsules, equivalent to 640 mg of mineral oil, every 24 hours in the morning with food.

Primary outcomes

  1. Cognitive status assessment

    Time frame: Assessed at baseline, 3, and 6 months.

    Cognitive status assessment using the Mini-Mental State Examination, which ranges from 0 to 30 points and the higher score is better with higher cognition

Secondary outcomes

  1. Patients' fatigue status

    Time frame: Assessed at baseline, 3, and 6 months.

    Evaluation using the 9-item Fatigue Severity Scale, which measures the severity of fatigue and its impact on the daily activities and lifestyle of patients. The scale ranges from 9 to 63 points and the higher the score, the worse the feeling of fatigue

  2. Selective attention and processing speed

    Time frame: Assessed at baseline, 3, and 6 months.

    Selective attention and processing speed will be evaluated using the Trail Making Test (TMT), where the average time for TMT Part A is 29 seconds, with more than 78 seconds being considered deficient. For TMT Part B, the average time is 75 seconds, and more than 273 seconds is considered deficient.

  3. Frailty

    Time frame: Assessed at baseline, 3, and 6 months.

    Frailty will be assessed using the Fried Frailty Criteria (Phenotype Model), which comprises five criteria. Based on these criteria. 0 criteria = No frailty; 1 to 2 criteria = Pre-frailty; 3 or more criteria = Frailty

Study contacts

Contact information is provided by the study sponsor or research team.

Abraham Samra Saad, Geriatrician and researcher

CONTACT

[email protected]

+525589510727

Alejandro Padilla Isassi, Geriatrician and researcher

CONTACT

[email protected]

+525589510727

Sponsors and collaborators

Lead sponsor

Distribuidora Biolife SA de CV

Industry

Registry information

Official study title

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

Acronym: COGMEG5

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 25, 2024
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.