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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Fondazione IRCCS San Gerardo dei Tintori
  Monza, Italy Recruiting

Study contacts

• Study coordinator: Carlo Ferrarese
• Email: carlo.ferrarese@unimib.it
• Phone: 0392333595

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.