Impact of NANO-PSO (omega 5) Supplementation on Cognitive Abilities of Older Adults with Mild to Moderate Non-vascular Cognitive Impairment
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Cognitive status assessment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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) ≤
- •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.
Arms & Interventions
NANO-PSO
640 mg of NANO-PSO (pomegranate seed oil)
Intervention: NANO-PSO (pomegranate seed oil) (Dietary Supplement)
Mineral oil
640 mg of mineral oil
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
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
- 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.)
Investigators
Alejandro Padilla Isassi
Principal researcher of the geriatrics area
Distribuidora Biolife SA de CV