Impact of NANO-PSO on Cognition in Older Adults with Mild to Moderate Cognitive Impairment (COGMEG5)

Distribuidora Biolife

Status and phase: Enrolling; Phase 2

Conditions: Cognition

Treatments: Dietary Supplement: Placebo; Dietary Supplement: NANO-PSO (pomegranate seed oil)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06520878

ENS-2024-TL001

Details and patient eligibility

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

NANO-PSO

Experimental group

Description:

640 mg of NANO-PSO (pomegranate seed oil)

Treatment:

Dietary Supplement: NANO-PSO (pomegranate seed oil)

Mineral oil

Placebo Comparator group

Description:

640 mg of mineral oil

Treatment:

Dietary Supplement: Placebo