NCT04962841

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
485

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2021

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2021

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

May 10, 2022

Status Verified

May 1, 2022

Enrollment Period

1.3 years

First QC Date

July 10, 2021

Last Update Submit

May 4, 2022

Conditions

Frailty

Keywords

frailtycognitive impairmentphysical impairmentolder adults

Outcome Measures

Primary Outcomes (1)

  • Montreal Cognitive Assessment (MoCA)

    Global cognitive impairment

    July 2021

Secondary Outcomes (1)

  • 5 metres gait speed test

    July 2021

Other Outcomes (1)

  • Correlation between MMSE/MoCA and 5 metres gait speed test

    July 2021

Study Arms (2)

Frail older adults treated with nutraceuticals and drugs

Other: Nutraceuticals

Frail older adults not treated with nutraceuticals and drugs

Interventions

NutraceuticalsOTHER

To observe the effect on cognitive and physical impairment.

Also known as: empaglifozin, nebivolol, sertraline, rivastigmine, metformin, ramipril, amlodipine
Frail older adults treated with nutraceuticals and drugs

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Frail older adults.

You may qualify if:

  • age \> 65 years;
  • a frailty status.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pasquale Mone

Naples, It, 80138, Italy

RECRUITING

Related Publications (5)

  • 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.

    PMID: 32130930BACKGROUND

  • 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.

    PMID: 24291279BACKGROUND

  • 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.

    PMID: 33780526BACKGROUND

  • 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.

    PMID: 35498050DERIVED

  • 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.

    PMID: 35287171DERIVED

MeSH Terms

Conditions

FrailtyCognitive Dysfunction

Interventions

Dietary SupplementsNebivololSertralineRivastigmineMetforminRamiprilAmlodipine

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring1-NaphthylamineNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsPhenylcarbamatesCarbamatesAcids, AcyclicCarboxylic AcidsBiguanidesGuanidinesAmidinesDihydropyridinesPyridines

Central Study Contacts

Pasquale Mone, MD

CONTACT

0823275386pasquale.mone@unicampania.it

Antonella Pansini, MD

CONTACT

0823275386apansini@asl.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 10, 2021

First Posted

July 15, 2021

Study Start

April 1, 2020

Primary Completion

July 22, 2021

Study Completion

April 1, 2023

Last Updated

May 10, 2022

Record last verified: 2022-05

Locations

IT(1)