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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Cognitive status assessment [Срок оценки: Assessed at baseline, 3, and 6 months.]

Вторичные конечные точки (3)

• Patients' fatigue status [Срок оценки: Assessed at baseline, 3, and 6 months.]
• Selective attention and processing speed [Срок оценки: Assessed at baseline, 3, and 6 months.]
• Frailty [Срок оценки: Assessed at baseline, 3, and 6 months.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Мексика · 1 центр

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

Публикации

• 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

Идентификаторы

NCT: NCT06520878 · ENS-2024-TL001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗