Nutraceuticals and Drug Treatment in Frail Older Adults

Frailty Clinical Trial

Official title:

Cognitive and Physical Impairment in Frail Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04962841
• Other study ID #: Campania Nord
• Status: Recruiting
• Start date: April 1, 2020
• Est. completion date: April 1, 2023

Study information

• Verified date: May 2022
• Source: University of Campania "Luigi Vanvitelli"
• Contact: Pasquale Mone, MD
• Phone: 0823275386
• Email: pasquale.mone[@]unicampania.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Frailty is a multidimensional condition due to reserve loss leading to physical and cognitive impairment that is very common in older adults; in fact, its incidence increases with age. Frail older adults present a high risk of adverse events such as disability, hospitalization and mortality. It is very important to check comorbidities and complications to reduce the incidence of cognitive and physical impairment.

Description:

Frailty is a multidimensional condition due to reserve loss leading to physical and cognitive impairment that is very common in older adults; in fact, its incidence increases with age. Frail older adults present a high-risk of adverse events such as disability, hospitalization and mortality. It is very important to check comorbidities and complications to reduce the incidence of cognitive and physical impairment; hence, clinical evaluation is the main goal to get an early diagnosis and a timely treatment for cognitive impairment. Considering this background, the study will investigate the effects of nutraceuticals and drug treatment on cognitive impairment in frail older adults. In this scenario, global cognitive function will be evaluated with Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) test and physical impairment with the Fried criteria and 5-metres gait speed test.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 485
• Est. completion date: April 1, 2023
• Est. primary completion date: July 22, 2021
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• age > 65 years;
• a frailty status.

Exclusion Criteria:

• age < 65 years.
• no frailty status.
• left ventricular ejection fraction <25%, with previous myocardial infarction or previous PPCI or/and coronary by-pass grafting.

Related Conditions & MeSH terms

• Frailty

Intervention

Other:
• Nutraceuticals
To observe the effect on cognitive and physical impairment.

Locations

Country	Name	City	State
Italy	Pasquale Mone	Naples	It

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Afilalo J, Alexander KP, Mack MJ, Maurer MS, Green P, Allen LA, Popma JJ, Ferrucci L, Forman DE. Frailty assessment in the cardiovascular care of older adults. J Am Coll Cardiol. 2014 Mar 4;63(8):747-62. doi: 10.1016/j.jacc.2013.09.070. Epub 2013 Nov 27. Review. — View Citation

Cortes-Canteli M, Iadecola C. Alzheimer's Disease and Vascular Aging: JACC Focus Seminar. J Am Coll Cardiol. 2020 Mar 3;75(8):942-951. doi: 10.1016/j.jacc.2019.10.062. Review. — View Citation

Jung HW, Baek JY, Jang IY, Guralnik JM, Rockwood K, Lee E, Kim DH. Short Physical Performance Battery as a Crosswalk Between Frailty Phenotype and Deficit Accumulation Frailty Index. J Gerontol A Biol Sci Med Sci. 2021 Nov 15;76(12):2249-2255. doi: 10.1093/gerona/glab087. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation between MMSE/MoCA and 5 metres gait speed test		July 2021
Primary	Montreal Cognitive Assessment (MoCA)	Global cognitive impairment	July 2021
Secondary	5 metres gait speed test	Physical impairment	July 2021