CognitionPhase 2COGMEG5NCT06520878
Impact of NANO-PSO on Cognition in Older Adults with Mild to Moderate Cognitive Impairment
A Phase 2 study testing NANO-PSO (pomegranate seed oil) in people with Cognition, run by Distribuidora Biolife SA de CV at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cognition
- What is being tested?
- NANO-PSO (pomegranate seed oil)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- 12 Feb 2025to 1 Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alejandro Padilla Isassi, Geriatrician and researcher contact
Mexico1 site, 1 recruiting
- Recruiting
Hospital Español. Av Ejercito Nacional 613, Miguel Hidalgo, CDMX, 11520
Miguel Hidalgo, Mexico City, 11520
Alejandro Padilla Isassi, Geriatrician, 5625592234, alejandropadillaisassi@gmail.com
About this study
Official title: Impact of NANO-PSO (omega 5) Supplementation on Cognitive Abilities of Older Adults with Mild to Moderate Non-vascular Cognitive Impairment
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?
Read more
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.
- Conditions
- Cognition
- Being tested
- NANO-PSO (pomegranate seed oil), Placebo
- Keywords
- NANO-PSO, Omega 5, Supplementation, Cognitive impairment, Antioxidants
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NANO-PSO (pomegranate seed oil)Dietary supplement
Also called Granagard, Omega 5
NANO-PSO administered orally, 2 capsules, equivalent to 640 mg of pomegranate seed oil, every 24 hours in the morning with food.
PlaceboDietary supplement
Placebo administered orally, 2 capsules, equivalent to 640 mg of mineral oil, every 24 hours in the morning with food.
| Study group | Role | What they receive |
|---|---|---|
| NANO-PSO | Experimental | 640 mg of NANO-PSO (pomegranate seed oil) Receives: Dietary Supplement: NANO-PSO (pomegranate seed oil) |
| Mineral oil | Placebo comparator | 640 mg of mineral oil Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive status assessment
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
Measured: Assessed at baseline, 3, and 6 months.
Secondary outcomes (3)
Patients' fatigue status
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
Measured: Assessed at baseline, 3, and 6 months.
Selective attention and processing speed
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.
Measured: Assessed at baseline, 3, and 6 months.
Frailty
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
Measured: Assessed at baseline, 3, and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start12 Feb 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CognitionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Distribuidora Biolife SA de CV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Alejandro Padilla Isassi, Distribuidora Biolife SA de CV
- Investigators
- Alejandro Padilla Isassi, Geriatrician and researcher, Principal investigator, Distribuidora Biolife S.A. de C.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520878
- Sponsor's protocol ID
- ENS-2024-TL001
- Acronym
- COGMEG5
- Status last verified
- Feb 2025
- First submitted
- 20 Jul 2024
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sharing the information has not been considered or thought of due to the confidentiality statuses of the Hospital Español
Publications
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.
PubMed 31804596
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of NANO-PSO (omega 5) Supplementation on Cognitive Abilities of Older Adults with Mild to Moderate Non-vascular Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06520878
- Acronym / sponsor ID
- COGMEG5 / ENS-2024-TL001
- Conditions
- Cognition
- Keywords
- NANO-PSO, Omega 5, Supplementation, Cognitive impairment, Antioxidants
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Distribuidora Biolife SA de CVIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NANO-PSO | Experimental | Dietary Supplement: NANO-PSO (pomegranate seed oil)640 mg of NANO-PSO (pomegranate seed oil) |
| Mineral oil | Placebo comparator | Dietary Supplement: Placebo640 mg of mineral oil |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NANO-PSO (pomegranate seed oil)Also: Granagard, Omega 5NANO-PSO administered orally, 2 capsules, equivalent to 640 mg of pomegranate seed oil, every 24 hours in the morning with food. | Dietary supplement | NANO-PSO |
| PlaceboPlacebo administered orally, 2 capsules, equivalent to 640 mg of mineral oil, every 24 hours in the morning with food. | Dietary supplement | Mineral oil |
Primary outcome
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
3 secondary outcomes
Patients' fatigue status
Time frame: Assessed at baseline, 3, and 6 months.
Selective attention and processing speed
Time frame: Assessed at baseline, 3, and 6 months.
Frailty
Time frame: Assessed at baseline, 3, and 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Background: PubMed 31804596Binyamin 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.
- Individual participant dataSharing planned: Undecided. Sharing the information has not been considered or thought of due to the confidentiality statuses of the Hospital Español
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alejandro Padilla Isassi, Geriatrician and researcher contact
Alejandro Padilla Isassi, Geriatrician and researcher principal investigator
Distribuidora Biolife S.A. de C.V.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NANO-PSO (pomegranate seed oil) in people with Cognition, run by Distribuidora Biolife SA de CV at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alejandro Padilla Isassi, Geriatrician and researcher (+525589510727, alejandropadillaisassi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive status assessment (time frame: Assessed at baseline, 3, and 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06520878, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.