Effects of a Nutraceutic Compound on Cognitive Impairment in Frailty Patients
| Registry | NCT06200883, acronym ENUCCI |
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| Status | Completed |
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| Phase | Phase 4 |
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| Study type | Interventional; randomized, parallel, masking: double, prevention |
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| Enrollment | 58 (Actual) |
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| Sponsor | Federico II University (Other) |
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| Conditions | Mild Cognitive Impairment |
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| Interventions | Placebo oral vial, Choline Bitartrate (Drug) |
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| Dates | start 2022-09-01, primary completion 2023-09-01, completion 2023-11-01, first posted 2024-01-11, last updated 2024-01-11 |
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| Locations | 1 site in Italy |
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Related Papers Related Patents Related Grants Related Experts
All trials for Mild Cognitive Impairment All trials of Placebo oral vial All trials of Choline Bitartrate
-Summary
The study is designed to evaluate the effects of choline bitartrate on cognitive impairment in frailty patients.
The study will analyze the impact of 4 weeks treatment randomized with a nutraceutical compound in a double-blind randomized placebo controlled trial. The investigators will also assess cognitive frailty.
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+Detailed description
The patients and controls will be recruited at the Hypertension research center of Federico II university hospital.
The overall duration of the study will be 4 weeks for each participant. Blood pressure, heart rate and cognitive frailty and cognitive impairment will be evaluated for each patient at randomization and after 4 weeks of treatment.
Patients or controls will be randomized to receive the nutraceutical compound (1 vial of CEREBRAIN per os with 1200 mg of choline bitartrate every 24 hours) or placebo (1 vial per os without active substance every 24 hours). Before the start of treatment, patients will undergo full examination of cognitive functions (MoCA and MMSE tests, the parameters will be reported in a password-protected database, using a identification code. The duration of the treatment will be 4 weeks. At the end of the treatment, the patients will repeat the tests and the results will be identified through the use of an alphanumeric code (POST-XXXYYY).
All CEREBRAIN and placebo, made up of the CEREBRAIN vehicle without the active substance, will be offered free of charge by the Farmaceutici DAMOR company.
+Arms and interventions
| Arm | Type | Interventions | Description |
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| Placebo | Placebo comparator | Drug: Placebo oral vial | Placebo oral tablet. In the Placebo group the participants take vehicle (1 vial per os every 24 hours) for 4 weeks |
| CERBRAIN | Active comparator | Drug: Choline Bitartrate | In the CEREBRAIN group the participants take CEREBRAIN (1 vial per os of 1.2 g every 24 hours) for 4 weeks |
- Placebo oral vial (Drug): In the Placebo group the participants take vehicle (1 vial per os every 24 hours) for 4 weeks
- Choline Bitartrate (Drug): In the CEREBRAIN group the participants take CEREBRAIN (1 vial per os of 1.2 g every 24 hours) for 4 weeks
+Outcome measures
Primary outcomes
- Change in Cognitive functions [4 weeks]: Cognitive functions will be assessed by MoCA test
- Change in Cognitive functions [4 weeks]: Cognitive functions will be assessed by MMSE test
Secondary outcomes
- Change in cognitive frailty [4 weeks]: Cognitive frailty will be assessed by the Fried criteria (at least 3/5 criteria whether MCI is diagnosed with the Clinical Dementia Rating Scale (0 to 5)
+Eligibility
Sex: All, ages: 40 Years to any
Inclusion Criteria:
* Mild cognitive impairment
Exclusion Criteria:
Ictus Atrial fibrillation Kidney diseases Cancer
+Locations (1)
| Facility | City | Country | Status |
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| Ambulatorio Ipertensione e Unità Coronarica Federico II University | Naples | Italy | |
+Publications
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- Results publication: Mohamed S, Lee Ming T, Jaffri JM. Cognitive enhancement and neuroprotection by catechin-rich oil palm leaf extract supplement. J Sci Food Agric. 2013 Mar 15;93(4):819-27. doi: 10.1002/jsfa.5802. Epub 2012 Sep 24. PMID 23001939
- Results publication: Morris MC, Evans DA, Tangney CC, Bienias JL, Wilson RS. Associations of vegetable and fruit consumption with age-related cognitive change. Neurology. 2006 Oct 24;67(8):1370-6. doi: 10.1212/01.wnl.0000240224.38978.d8. PMID 17060562
- Results publication: Snitz BE, O'Meara ES, Carlson MC, Arnold AM, Ives DG, Rapp SR, Saxton J, Lopez OL, Dunn LO, Sink KM, DeKosky ST; Ginkgo Evaluation of Memory (GEM) Study Investigators. Ginkgo biloba for preventing cognitive decline in older adults: a randomized trial. JAMA. 2009 Dec 23;302(24):2663-70. doi: 10.1001/jama.2009.1913. PMID 20040554