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

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.

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2025-07-29