Effects of a Nutraceutic Compound on Cognitive Impairment

NCT06200883 | Completed Phase 4 DMC

• 1 other identifier: CEREBRAIN
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild Cognitive Impairment

Keywords

Physical frailty; Cognitive frailty; Cognitive impairment

Outcome Measures

Primary Outcomes (2)

• Change in Cognitive functions

  Cognitive functions will be assessed by MoCA test

  4 weeks

• Change in Cognitive functions

  Cognitive functions will be assessed by MMSE test

  4 weeks

Secondary Outcomes (1)

• Change in cognitive frailty

  4 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo oral vial

CERBRAIN

ACTIVE COMPARATOR

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

Drug: Choline Bitartrate

Interventions

Placebo oral vial DRUG

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

Placebo

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

CERBRAIN

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild cognitive impairment

You may not qualify if:

• Ictus Atrial fibrillation Kidney diseases Cancer

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Ambulatorio Ipertensione e Unità Coronarica Federico II University

Napoli, 80131, Italy

Location

Related Publications (8)

• 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.

  PMID: 18611150 RESULT

• 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.

  PMID: 8323999 RESULT

• 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.

  PMID: 22090468 RESULT

• 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.

  PMID: 16469995 RESULT

• 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.

  PMID: 25733639 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Choline

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Onium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Raffaele Izzo

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 11, 2024
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: November 1, 2023
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)