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

ConditionCognition
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorDistribuidora Biolife SA de CV

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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

Treatments tested in this trial

  • NANO-PSO (pomegranate seed oil)
  • Placebo

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators