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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NANO-PSO | Experimental | 640 mg of NANO-PSO (pomegranate seed oil) |
|
| Mineral oil | Placebo Comparator | 640 mg of mineral oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NANO-PSO (pomegranate seed oil) | Dietary Supplement | NANO-PSO administered orally, 2 capsules, equivalent to 640 mg of pomegranate seed oil, every 24 hours in the morning with food. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Assessed at baseline, 3, and 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Assessed at baseline, 3, and 6 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alejandro Padilla Isassi, Geriatrician and researcher | Contact | +525589510727 | alejandropadillaisassi@gmail.com | |
| Abraham Samra Saad, Geriatrician and researcher | Contact | +525589510727 | abrahamsamra@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Alejandro Padilla Isassi, Geriatrician and researcher | Distribuidora Biolife S.A. de C.V. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Español. Av Ejercito Nacional 613, Miguel Hidalgo, CDMX, 11520 | Recruiting | Miguel Hidalgo | Mexico City | 11520 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31804596 | Background | 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. |
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Sharing the information has not been considered or thought of due to the confidentiality statuses of the Hospital Español
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000627796 | Nano-PSO |
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|
| Placebo | Dietary Supplement | Placebo administered orally, 2 capsules, equivalent to 640 mg of mineral oil, every 24 hours in the morning with food. |
|
| 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. |
| 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 | Assessed at baseline, 3, and 6 months. |