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

Recruiting now · Not applicable

Conditions studied: Age-related Cognitive Decline

In brief

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.

Key facts

Study ID: NCT06248723
Run by: University of Milano Bicocca
People needed: 1340
Starts: 2024-07-16
Expected to finish: 2026-03-01
Last updated by the study team: 2025-07-29

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Aged 60 or older
Mild/moderate vulnerability (Primary Care Frailty Index score between 0.07 and 0.21)
Cardiovascular risk factors, Ageing and Incidence of Dementia (CAIDE) > 6
Clinical Dementia Rating (CDR) ≤ 0.5
Presence of increased risk of developing dementia by family history (≥ 1 family member with dementia) and/or at least one modifiable risk factor, with Lifestyle Index ≥2. Lifestyle index evaluation: each "Yes" answer to the following questions = 1 point.
Physical activity less than 2.5 hours per week (defined as physical activity intense enough to lead to sweating and breathlessness)*
Diet: less than 5 servings of fruits and vegetables per day*
Diet: less than 2 servings of fish per week*
Hypertension: diagnosed by a physician or on medication, or Systolic Blood Pressure (SBP)>140 mmHg, or Diastolic Blood Pressure (DBP)>90 mmHg)
Diabetes: type 1 or type 2 diagnosed by a physician, or on medication, or HbA1C ≥7 % in the previous 6 months
Sleep disturbances, depressive symptoms, or mental/physical stress symptoms, for at least 1 month, judged by the physician to be disabling in daily life
BMI ≥ 25 kg/m\^2*
Alcohol: > 21 alcohol units/week*. *Based on international and WHO guidelines.
Informed consent freely given and acquired before the start of the study

You may not qualify if…

Diagnosis of dementia or suspected dementia following the screening visit
CDR > 0.5
Residents in residential facilities for the elderly
Inability to consent to informed consent and/or actively participate in study interventions, according to clinical judgment
Any condition that prevents safe involvement in the intervention and/or cooperation in the study. For example, a significant neurological or psychiatric condition, including but not limited to brain tumors (benign or malignant), major psychiatric disorders (e.g. current major depressive disorder, schizophrenia, schizoaffective disorder or bipolar disorder), recent brain hemorrhage (parenchymal or subdural), history of concussive head trauma with persistent or significant neurological outcomes, known morpho-structural abnormalities in the brain, active alcohol/drug abuse, active uncontrolled disease of any major organ system; history within the last six months of any acute disease of a major organ system requiring emergency care or hospitalization, including revascularization procedures; severe renal or hepatic insufficiency; unstable or poorly controlled diabetes mellitus, hypertension, or heart failure; malignant neoplasms within the past 3 years (except basal cell carcinoma or squamous cell carcinoma in situ of the skin or localized prostate adenocarcinoma in male participants); any clinically relevant abnormality in blood parameters; severe loss of vision, smar or communication ability, such as to prevent cooperation.
Enrollment in other trials
High performance on screening memory tests: RAVL-T immediate score >48 (score ranges 0-75), RAVL-T delayed >10 (score ranges 0-15)
Planned transfers from the municipality of residence during the duration of the study for a duration longer than 2 weeks.

Where it is running

Fondazione IRCCS San Gerardo dei Tintori — Monza, Italy (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.