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FrailtyNCT04962841

Nutraceuticals and Drug Treatment in Frail Older Adults

An observational study of Frailty, run by University of Campania Luigi Vanvitelli at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Frailty
What is being tested?
Nutraceuticals
How many people
485 participants
Where
1 siteItaly
Study dates
1 Apr 2020to 1 Apr 2023
Phase
Observational
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 65 years and older
  • All sexes
  • Older adult

Study population: Frail older adults.

Who may be able to join

  • age > 65 years;
  • a frailty status.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Pasquale Mone, MD contact

0823275386

pasquale.mone@unicampania.it

Antonella Pansini, MD contact

0823275386

apansini@asl.it

Italy1 site, 1 recruiting

  • Pasquale Mone

    Naples, It, 80138

    Antonella Pansini, MD, 0823275386, apansini@aslavellino.it

    Recruiting

Other trials in Italy

About this study

Official title: Cognitive and Physical Impairment in Frail Older Adults

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.

Read the detailed 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.

Conditions
Frailty
Being tested
Nutraceuticals
Keywords
frailty, cognitive impairment, physical impairment, older adults
Medical subject headings
Frailty, Cognitive Dysfunction

What participants receive

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

  • NutraceuticalsOther

    Also called empaglifozin, nebivolol, sertraline, rivastigmine

    To observe the effect on cognitive and physical impairment.

Study groups in NCT04962841
Study groupRoleWhat they receive
Frail older adults treated with nutraceuticals and drugsNot described
Receives: Other: Nutraceuticals
Frail older adults not treated with nutraceuticals and drugsNot described

What is being measured

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

  1. Montreal Cognitive Assessment (MoCA)

    Global cognitive impairment

    Measured: July 2021

Secondary outcomes (1)

  1. 5 metres gait speed test

    Physical impairment

    Measured: July 2021

Timeline

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

  1. First posted15 Jul 2021
  2. Study start1 Apr 2020
  3. Primary completion22 Jul 2021
  4. Study completion1 Apr 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
485 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04962841
Sponsor's protocol ID
Campania Nord
Status last verified
May 2022
First submitted
10 Jul 2021
Last updated
10 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 32130930

  • 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.

    PubMed 24291279

  • 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.

    PubMed 33780526

  • 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.

    PubMed 35498050

  • 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.

    PubMed 35287171

Questions about this trial

What is this clinical trial studying?

An observational study of Frailty, run by University of Campania Luigi Vanvitelli 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 May 2022. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

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

Contact Pasquale Mone, MD (0823275386, pasquale.mone@unicampania.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Montreal Cognitive Assessment (MoCA) (time frame: July 2021). 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 NCT04962841, which also lists 5 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 10 May 2022.

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