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New treatment option for Age-related Cognitive Decline
Official title ItaliaN Study With Tailored Multidomain Interventions to Prevent Functional and Cognitive Decline in Community-dwelling Older Adults
ClinicalTrials.gov ID: NCT06248723
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older. Healthy volunteers may be eligible.
You may be able to join 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...
You likely can't join 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...
- Enrollment in other trials
See the full eligibility 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...
- 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
- 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...
- 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 study team makes the final eligibility decision.
Where it's taking place
- Monza, Italy
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Monza, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.