Personalized multi-domain program to prevent thinking and physical decline in older adults

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

This study will test whether a tailored program of exercise, a Mediterranean-style diet, cognitive training, and other health supports can help people aged 60+ at risk of cognitive decline keep their memory and daily function.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1340 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: University of Milano Bicocca (other)
• Locations: 1 site (Monza)
• Trial ID: NCT06248723 on ClinicalTrials.gov

What this trial studies

This multicenter Italian trial compares a tailored 'active' multi-domain intervention to a self-guided approach in community-dwelling older adults at increased risk for dementia. The active intervention combines supervised physical exercise, a Mediterranean diet plan, cognitive training, oral hygiene care, sleep counseling, vision/hearing monitoring, regular medical reviews, and management of cardiovascular, metabolic, and infectious risk factors. Participants are screened with measures including the Primary Care Frailty Index (PC-FI), CAIDE risk score, Clinical Dementia Rating (CDR), GPCOG, Rey Auditory Verbal Learning tests, and the Short Physical Performance Battery, and are enrolled via general practitioners or participating centers. The primary focus is whether the multi-domain program can prevent or slow functional and cognitive decline in at-risk older adults.

Who should consider this trial

Good fit: Ideal candidates are community-dwelling adults aged 60 or older with mild-to-moderate frailty (PC-FI 0.07–0.21), CAIDE score >6, CDR ≤0.5, and either a family history of dementia or at least one modifiable/lifestyle risk factor (Lifestyle Index ≥2).

Not a fit: People with more advanced dementia (CDR >0.5), severe frailty, unstable major medical conditions, or without modifiable risk factors are unlikely to receive benefit from this preventive program.

Why it matters

Potential benefit: If successful, this program could slow or prevent cognitive and physical decline and help older adults remain independent longer.

How similar studies have performed: Previous multidomain prevention trials such as FINGER have shown modest cognitive benefits while others (MAPT, PreDIVA) reported mixed results, so the approach is promising but not uniformly confirmed.

Eligibility criteria

Inclusion Criteria:

* 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.

  1. Physical activity less than 2.5 hours per week (defined as physical activity intense enough to lead to sweating and breathlessness)\*
  2. Diet: less than 5 servings of fruits and vegetables per day\*
  3. Diet: less than 2 servings of fish per week\*
  4. Hypertension: diagnosed by a physician or on medication, or Systolic Blood Pressure (SBP)\>140 mmHg, or Diastolic Blood Pressure (DBP)\>90 mmHg)
  5. Diabetes: type 1 or type 2 diagnosed by a physician, or on medication, or HbA1C ≥7 % in the previous 6 months
  6. Sleep disturbances, depressive symptoms, or mental/physical stress symptoms, for at least 1 month, judged by the physician to be disabling in daily life
  7. BMI ≥ 25 kg/m\^2\*
  8. Alcohol: \> 21 alcohol units/week\*. \*Based on international and WHO guidelines.
* Informed consent freely given and acquired before the start of the study

Exclusion Criteria:

* 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 this trial is running

Monza

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

Study contacts

• Study coordinator: Carlo Ferrarese

Conditions: Age-related Cognitive Decline, Cognitive decline, Dementia, Aging