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

NCT06520878 | Recruiting Phase 2 DMC

• 1 other identifier: ENS-2024-TL001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cognition

Keywords

NANO-PSO; Omega 5; Supplementation; Cognitive impairment; Antioxidants

Outcome Measures

Primary Outcomes (1)

• Cognitive status assessment

  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

  Assessed at baseline, 3, and 6 months.

Secondary Outcomes (3)

• Patients' fatigue status

  Assessed at baseline, 3, and 6 months.

• Selective attention and processing speed

  Assessed at baseline, 3, and 6 months.

• Frailty

  Assessed at baseline, 3, and 6 months.

Study Arms (2)

NANO-PSO

EXPERIMENTAL

640 mg of NANO-PSO (pomegranate seed oil)

Dietary Supplement: NANO-PSO (pomegranate seed oil)

Mineral oil

PLACEBO COMPARATOR

640 mg of mineral oil

Dietary Supplement: Placebo

Interventions

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.

Also known as: Granagard, Omega 5

NANO-PSO

Placebo DIETARY_SUPPLEMENT

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

Mineral oil

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 may not qualify 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.

Sponsors & Collaborators

• Distribuidora Biolife SA de CV: lead

Study Sites (1)

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

Miguel Hidalgo, Mexico City, 11520, Mexico

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Nano-PSO

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Alejandro Padilla Isassi, Geriatrician and researcher

  Distribuidora Biolife S.A. de C.V.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alejandro Padilla Isassi, Geriatrician and researcher

CONTACT

+525589510727; alejandropadillaisassi@gmail.com

Abraham Samra Saad, Geriatrician and researcher

CONTACT

+525589510727; abrahamsamra@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal researcher of the geriatrics area

Study Record Dates

• First Submitted: July 20, 2024
• First Posted: July 25, 2024
• Study Start: February 12, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

ME (1)