Phase
Condition
Aging
Dementia
Memory Loss
Treatment
Cognitive training
Physical exercise
Sleep quality
Clinical Study ID
Ages > 60 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 familymember with dementia) and/or at least one modifiable risk factor, with LifestyleIndex ≥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 activityintense 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 BloodPressure (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
Exclusion
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 studyinterventions, according to clinical judgment
Any condition that prevents safe involvement in the intervention and/or cooperationin the study. For example, a significant neurological or psychiatric condition,including but not limited to brain tumors (benign or malignant), major psychiatricdisorders (e.g. current major depressive disorder, schizophrenia, schizoaffectivedisorder or bipolar disorder), recent brain hemorrhage (parenchymal or subdural),history of concussive head trauma with persistent or significant neurologicaloutcomes, known morpho-structural abnormalities in the brain, active alcohol/drugabuse, active uncontrolled disease of any major organ system; history within thelast six months of any acute disease of a major organ system requiring emergencycare or hospitalization, including revascularization procedures; severe renal orhepatic insufficiency; unstable or poorly controlled diabetes mellitus,hypertension, or heart failure; malignant neoplasms within the past 3 years (exceptbasal cell carcinoma or squamous cell carcinoma in situ of the skin or localizedprostate adenocarcinoma in male participants); any clinically relevant abnormalityin blood parameters; severe loss of vision, smar or communication ability, such asto 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 thestudy for a duration longer than 2 weeks.
Study Design
Study Description
Connect with a study center
Fondazione IRCCS San Gerardo dei Tintori
Monza,
ItalyActive - Recruiting

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