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

Age-related Cognitive Decline Clinical Trial

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

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

The study is multicentric and will include 10 centers. Patients will be enrolled either through their General Practitioners (GPs), which will then refer back to their reference centers, or through the centers themselves.

Patients will undergo a screening visit, which will include a multi-faceted evaluation of cognitive function, physical and functional efficiency, and cardiovascular and cognitive decline risk factors. Procedures to be carried out during the screening visit include:

• Collection of socio-demographic data (age, sex, marital status, cohabitation, level of education, social interactions), clinical details (medical and medication history), and evaluation of inclusion/exclusion criteria

• Assessment of the degree of frailty through the Primary Care Frailty Index (PC-FI)

• Assessment of the presence of increased risk of developing dementia through the Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) score

• Assessment of cognitive performance through the General Practitioner assessment of COGnition (GPCOG)

• Assessment of cognitive performance through the Rey Auditory Verbal Learning Test - immediate

• Assessment of functional status by Short Physical Performance Battery (SPPB) tests

• Nonverbal interference tests

• Assessment of cognitive performance through the Rey Auditory Verbal Learning online version (RAVL-T delayed)

• Collection of self-administered scales for cognitive performance assessment through the Test Your Memory - Italian (TYM-I) scale.

Then, eligible patients will be enrolled for the second, active intervention phase of the study, which will include a baseline visit and 3 follow-up visits, at 6, 12, and 18 months.

During these visits, primary and secondary endpoint outcomes will be collected according to protocol. ;

Related Conditions & MeSH terms

• Age-related Cognitive Decline
• Cognitive Dysfunction

• NCT number: NCT06248723
• Study type: Interventional
• Source: University of Milano Bicocca
• Contact: Carlo Ferrarese
• Phone: 0392333595
• Email: carlo.ferrarese@unimib.it
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Completion date: March 2026