NCT06520878 Impact of NANO-PSO on Cognition in Older Adults with Mild to Moderate Cognitive Impairment
| NCT ID | NCT06520878 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Distribuidora Biolife SA de CV |
| Condition | Cognition |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-02-12 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2025-02-12 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 \"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.
Contact & Investigator
Alejandro Padilla Isassi, Geriatrician and researcher
✉ alejandropadillaisassi@gmail.com📞 +525589510727
Alejandro Padilla Isassi, Geriatrician and researcher
PRINCIPAL INVESTIGATOR
Distribuidora Biolife S.A. de C.V.
Frequently Asked Questions
Who can join the NCT06520878 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Cognition. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06520878 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06520878 currently recruiting?
Yes, NCT06520878 is actively recruiting participants. Contact the research team at alejandropadillaisassi@gmail.com for enrollment information.
Where is the NCT06520878 trial being conducted?
This trial is being conducted at Miguel Hidalgo, Mexico.
Who is sponsoring the NCT06520878 clinical trial?
NCT06520878 is sponsored by Distribuidora Biolife SA de CV. The principal investigator is Alejandro Padilla Isassi, Geriatrician and researcher at Distribuidora Biolife S.A. de C.V.. The trial plans to enroll 60 participants.