Clinical trial NCT06520878: Impact of NANO-PSO on Cognition in Older Adults with Mild to Moderate Cognitive Impairment
Official title: Impact of NANO-PSO (omega 5) Supplementation on Cognitive Abilities of Older Adults with Mild to Moderate Non-vascular Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cognition
Keywords: NANO-PSO
Omega 5
Supplementation
Cognitive impairment
Antioxidants
Lead sponsor: Distribuidora Biolife SA de CV
Sponsor class: INDUSTRY
First posted: 2024-07-25
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 \&#34;probable dementia\&#34; 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.

Primary outcomes:
measure: Cognitive status assessment
timeFrame: Assessed at baseline, 3, and 6 months.
Secondary outcomes:
measure: Patients' fatigue status
timeFrame: Assessed at baseline, 3, and 6 months.
measure: Selective attention and processing speed
timeFrame: Assessed at baseline, 3, and 6 months.
measure: Frailty
timeFrame: Assessed at baseline, 3, and 6 months.
Other outcomes:
Locations:
city: Miguel Hidalgo
country: Mexico
facility: Hospital Español. Av Ejercito Nacional 613, Miguel Hidalgo, CDMX, 11520
state: Cdmx
Study officials:
affiliation: Distribuidora Biolife S.A. de C.V.
name: Alejandro Padilla Isassi, Geriatrician and researcher
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.