Nutraceuticals and Drug Treatment in Frail Older Adults

NCT ID: NCT04962841

Last Updated: 2022-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

485 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2023-04-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Frailty

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Frail older adults treated with nutraceuticals and drugs

Nutraceuticals

Intervention Type OTHER

To observe the effect on cognitive and physical impairment.

Frail older adults not treated with nutraceuticals and drugs

No interventions assigned to this group

Interventions

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Nutraceuticals

To observe the effect on cognitive and physical impairment.

Intervention Type OTHER

Other Intervention Names

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empaglifozin nebivolol sertraline rivastigmine metformin ramipril amlodipine

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Campania Luigi Vanvitelli

OTHER

Sponsor Role lead

Responsible Party

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Pasquale Mone

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pasquale Mone

Naples, It, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Pasquale Mone, MD

Role: CONTACT

0823275386

Antonella Pansini, MD

Role: CONTACT

0823275386

Facility Contacts

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Antonella Pansini, MD

Role: primary

0823275386

References

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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.

Reference Type BACKGROUND
PMID: 32130930 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24291279 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33780526 (View on PubMed)

Mone P, Pansini A, Jankauskas SS, Varzideh F, Kansakar U, Lombardi A, Trimarco V, Frullone S, Santulli G. L-Arginine Improves Cognitive Impairment in Hypertensive Frail Older Adults. Front Cardiovasc Med. 2022 Apr 12;9:868521. doi: 10.3389/fcvm.2022.868521. eCollection 2022.

Reference Type DERIVED
PMID: 35498050 (View on PubMed)

Mone P, Lombardi A, Gambardella J, Pansini A, Macina G, Morgante M, Frullone S, Santulli G. Empagliflozin Improves Cognitive Impairment in Frail Older Adults With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction. Diabetes Care. 2022 May 1;45(5):1247-1251. doi: 10.2337/dc21-2434.

Reference Type DERIVED
PMID: 35287171 (View on PubMed)

Other Identifiers

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Campania Nord

Identifier Type: -

Identifier Source: org_study_id

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