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

Phase 2

Recruiting

• Conditions: Cognition

• Registration Number: NCT06520878
• Lead Sponsor: Distribuidora Biolife SA de CV

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-20
• Study First Submitted QC: 2024-07-20
• Study First Posted: 2024-07-25
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-06
• Study Start: 2025-02-12
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cognitive status assessment	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 Outcome Measures

Name	Time	Method
Frailty	Assessed at baseline, 3, and 6 months.	Frailty will be assessed using the Fried Frailty Criteria (Phenotype Model), which comprises five criteria. Based on these criteria. 0 criteria = No frailty; 1 to 2 criteria = Pre-frailty; 3 or more criteria = Frailty
Patients' fatigue status	Assessed at baseline, 3, and 6 months.	Evaluation using the 9-item Fatigue Severity Scale, which measures the severity of fatigue and its impact on the daily activities and lifestyle of patients. The scale ranges from 9 to 63 points and the higher the score, the worse the feeling of fatigue
Selective attention and processing speed	Assessed at baseline, 3, and 6 months.	Selective attention and processing speed will be evaluated using the Trail Making Test (TMT), where the average time for TMT Part A is 29 seconds, with more than 78 seconds being considered deficient. For TMT Part B, the average time is 75 seconds, and more than 273 seconds is considered deficient.

Trial Locations

Locations (1)

Hospital Español. Av Ejercito Nacional 613, Miguel Hidalgo, CDMX, 11520; 🇲🇽 Miguel Hidalgo, Cdmx, Mexico