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Mild Cognitive ImpairmentPhase 4ENUCCINCT06200883

Effects of a Nutraceutic Compound on Cognitive Impairment

A Phase 4 study testing Choline Bitartrate in people with Mild Cognitive Impairment, run by Federico II University at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Mild Cognitive Impairment
What is being tested?
Choline Bitartrate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
58 participants
Where
1 siteItaly
Study dates
1 Sep 2022to 1 Nov 2023
Phase
Phase 4
Are there results?
None posted in the registry

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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Mild cognitive impairment

Who cannot join

  • Ictus Atrial fibrillation Kidney diseases Cancer

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Ambulatorio Ipertensione e Unità Coronarica Federico II University

    Naples, 80131

Other trials in Italy

About this study

Official title: Effects of a Nutraceutic Compound on Cognitive Impairment in Frailty Patients

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.

Read the 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.

Being tested
Placebo oral vial, Choline Bitartrate
Keywords
Physical frailty, Cognitive frailty, Cognitive impairment
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo oral vialDrug

    In the Placebo group the participants take vehicle (1 vial per os every 24 hours) for 4 weeks

  • Choline BitartrateDrug

    In the CEREBRAIN group the participants take CEREBRAIN (1 vial per os of 1.2 g every 24 hours) for 4 weeks

Study groups in NCT06200883
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo oral tablet. In the Placebo group the participants take vehicle (1 vial per os every 24 hours) for 4 weeks
Receives: Drug: Placebo oral vial
CERBRAINActive comparatorIn the CEREBRAIN group the participants take CEREBRAIN (1 vial per os of 1.2 g every 24 hours) for 4 weeks
Receives: Drug: Choline Bitartrate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Cognitive functions

    Cognitive functions will be assessed by MoCA test

    Measured: 4 weeks

  2. Change in Cognitive functions

    Cognitive functions will be assessed by MMSE test

    Measured: 4 weeks

Secondary outcomes (1)

  1. Change in cognitive frailty

    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)

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2024
  2. Study start1 Sep 2022
  3. Primary completion1 Sep 2023
  4. Study completion1 Nov 2023

Resources

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06200883
Sponsor's protocol ID
CEREBRAIN
Acronym
ENUCCI
Status last verified
Jan 2024
First submitted
21 Dec 2023
Last updated
11 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Calabrese C, Gregory WL, Leo M, Kraemer D, Bone K, Oken B. Effects of a standardized Bacopa monnieri extract on cognitive performance, anxiety, and depression in the elderly: a randomized, double-blind, placebo-controlled trial. J Altern Complement Med. 2008 Jul;14(6):707-13. doi: 10.1089/acm.2008.0018.

    PubMed 18611150

  • Cenacchi T, Bertoldin T, Farina C, Fiori MG, Crepaldi G. Cognitive decline in the elderly: a double-blind, placebo-controlled multicenter study on efficacy of phosphatidylserine administration. Aging (Milano). 1993 Apr;5(2):123-33. doi: 10.1007/BF03324139.

    PubMed 8323999

  • Kesse-Guyot E, Fezeu L, Andreeva VA, Touvier M, Scalbert A, Hercberg S, Galan P. Total and specific polyphenol intakes in midlife are associated with cognitive function measured 13 years later. J Nutr. 2012 Jan;142(1):76-83. doi: 10.3945/jn.111.144428. Epub 2011 Nov 16.

    PubMed 22090468

  • Kuriyama S, Hozawa A, Ohmori K, Shimazu T, Matsui T, Ebihara S, Awata S, Nagatomi R, Arai H, Tsuji I. Green tea consumption and cognitive function: a cross-sectional study from the Tsurugaya Project 1. Am J Clin Nutr. 2006 Feb;83(2):355-61. doi: 10.1093/ajcn/83.2.355.

    PubMed 16469995

  • Mastroiacovo D, Kwik-Uribe C, Grassi D, Necozione S, Raffaele A, Pistacchio L, Righetti R, Bocale R, Lechiara MC, Marini C, Ferri C, Desideri G. Cocoa flavanol consumption improves cognitive function, blood pressure control, and metabolic profile in elderly subjects: the Cocoa, Cognition, and Aging (CoCoA) Study--a randomized controlled trial. Am J Clin Nutr. 2015 Mar;101(3):538-48. doi: 10.3945/ajcn.114.092189. Epub 2014 Dec 17.

    PubMed 25733639

  • 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.

    PubMed 23001939

  • 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.

    PubMed 17060562

  • 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.

    PubMed 20040554

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Choline Bitartrate in people with Mild Cognitive Impairment, run by Federico II University at 1 site in Italy.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 11 Jan 2024. 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 Italy. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Cognitive functions (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 NCT06200883, which also lists 8 linked publications.

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 11 Jan 2024.

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