IN-TeMPO (Italy)

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

The IN-TeMPO study investigates the effects of an active, guided multi-domain intervention compared to a self-guided intervention followed by normal clinical practice. The primary objective is whether these interventions can prevent functional and cognitive decline in older adults at risk of cognitive decline. The intervention includes the same five lifestyle domains as the FINGER study as well as novel factors such as oral hygiene, vision and hearing, and sleep. A comprehensive set of laboratory biomarkers will be measured to gain new insights into underlying mechanisms and to further support the development of prevention and early detection strategies.

Aim of the project

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.

Location

Nine clinical centers across north, central, and south Italy: Monza, Novara, Florence, Rome, Naples, Bari, Catania, Palermo, and Molise.

Local setting

Recruitment has taken place both at clinical centers, through internal referral and/or advertising on local newspapers, and at general practitioners.
The trial was designed to draw from both major urban centers and rural areas in order to ensure a diverse representation.

Leading organization

University of Milano-Bicocca

Principal Investigator (PI)

Carlo Ferrarese, University of Milano-Bicocca

Research team

University of Milano-Bicocca:
Luca Cuffaro
Federico Emanuele Pozzi
Gessica Sala

Duration of the intervention

12 months

Project start date

2024

Project end date

2026

Current stage of the project

Ongoing

Number of study participants

1,534 estimated; 835 enrolled

Target population

Community-dwelling older adults aged 60 years or more with mild to moderate frailty. In addition, presence of family history of dementia, and/or at least one modifiable risk factor of dementia.

Primary outcome

Change in global cognition assessed by mNTB, a battery of cognitive tests

Secondary outcomes

Individual cognitive domains
Physical activity
Cognitive and functional levels
Resilience
Falls
Depressive symptoms
Loneliness
Quality of life and well-being
Sleep quality
Nutrition
Biomarkers: APOE genotype, p-tau217, NfL, GFAP, IL-6, etc.

Intervention

This study has 2 arms:

Multidomain intervention
Self-guided intervention (control group): participants receive suggestions through app-web or video tutorials on the same domains

└ Multidomain intervention

Physical exercise
Nutrition: Mediterranean diet-based nutritional plan
Cognitive training: using BrainHQ program
Monitoring of cardiovascular risk factors
Oral hygiene
Monitoring and counselling on visual and auditory abilities
Sleep hygiene
Social interactions

Digital solutions

BrainHQ is a self-adapting cognitive training software, scientifically validated from previous studies. The enrolled subject has the possibility of receiving a tablet to run the software in case of need.
A wearable tracker (Garmin Vivosmart) will collect movement data (steps, pace, speed, and activity types) and cardiac data (heart rate, heart rate variability), scientifically validated from previous studies. The device is given to enrolled subjects for the first and last month of participation.
A specific website has been created for self-guided group of subjects with educational materials ordered to be delivered in a precise temporal sequence to maintain compliance to the study
A digital coach is appointed for each recruitment center to help enrolled subjects in approaching the digital tools

Results

Results have not yet been published.

Acknowledgements

Funding from Next Generation EU, in the context of the National Recovery and Resilience Plan, Investment PE8 – Project Age-It: “Ageing Well in an Ageing Society” [DM 1557 11.10.2022, CUP: H43C22000840006].