Actively Recruiting

Phase Not Applicable
Age: 60Years +
All Genders
Healthy Volunteers
NCT06248723

ItaliaN Study With Tailored Multidomain Interventions to Prevent Functional and Cognitive Decline in Community-dwelling Older Adults

Led by University of Milano Bicocca · Updated on 2025-07-29

1340

Participants Needed

1

Research Sites

84 weeks

Total Duration

On this page

Sponsors

U

University of Milano Bicocca

Lead Sponsor

E

European Union

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this interventional non-pharmacological study is to investigate the effects of a multi-domain intervention ( "active intervention"), compared to that followed by normal clinical practice ("self-guided intervention"), in older adults. The primary objective is whether these interventions can prevent functional and cognitive decline in at-risk subjects. The multi-domain interventions will include physical exercise, a Mediterranean diet-based nutritional plan, cognitive training, regular medical check-ups, oral hygiene treatments and counseling, monitoring and counseling on visual and auditory abilities, counseling on sleep hygiene and treatment, control of cardiovascular, metabolic, and infectious risk factors, adjustment of drug therapy, suggestions for improving social interactions.

CONDITIONS

Official Title

ItaliaN Study With Tailored Multidomain Interventions to Prevent Functional and Cognitive Decline in Community-dwelling Older Adults

Who Can Participate

Age: 60Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 60 or older
  • Mild to moderate vulnerability with Primary Care Frailty Index score between 0.07 and 0.21
  • Cardiovascular risk factors, Ageing and Incidence of Dementia (CAIDE) score greater than 6
  • Clinical Dementia Rating (CDR) of 0.5 or less
  • Increased risk of developing dementia by family history (at least one family member with dementia) and/or at least one modifiable risk factor with Lifestyle Index 2 or higher
  • Provided informed consent freely before the study start
Not Eligible

You will not qualify if you...

  • Diagnosis or suspected diagnosis of dementia following screening
  • Clinical Dementia Rating (CDR) greater than 0.5
  • Residents in residential elderly facilities
  • Unable to consent or actively participate in study interventions
  • Any condition preventing safe involvement or cooperation, including major neurological or psychiatric conditions, recent brain hemorrhage, significant head trauma, brain abnormalities, active substance abuse, uncontrolled major diseases, recent malignant neoplasms (except certain skin or localized prostate cancers), or severe sensory or communication loss
  • Enrollment in other clinical trials
  • High performance on screening memory tests (RAVL-T immediate score above 48, delayed score above 10)
  • Planned residence transfers longer than 2 weeks during the study period

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Fondazione IRCCS San Gerardo dei Tintori

Monza, Italy

Actively Recruiting

Loading map...

Research Team

C

Carlo Ferrarese

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here