Clinical trial NCT06248723: ItaliaN Study With Tailored Multidomain Interventions to Prevent Functional and Cognitive Decline in Community-dwelling Older Adults
Official title: ItaliaN Study With Tailored Multidomain Interventions to Prevent Functional and Cognitive Decline in Community-dwelling Older Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Age-related Cognitive Decline
Keywords: Cognitive decline
Dementia
Aging
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
Collaborators: name: European Union
First posted: 2024-02-08
Enrollment: 1340
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients are randomized 1:1 into "active intervention" and "self-guided intervention" parallel groups.
Primary purpose: PREVENTION

Brief summary: 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.

The multi-domain interventions will include physical exercise, a Mediterranean diet-based nutritional plan, cognitive training, regular medical check-ups, oral hygiene treatments and counseling, monitoring and counseling on visual and auditory abilities, counseling on sleep hygiene and treatment, control of cardiovascular, metabolic, and infectious risk factors, adjustment of drug therapy, suggestions for improving social interactions.

Detailed description: The study is multicentric and will include 10 centers. Patients will be enrolled either through their General Practitioners (GPs), which will then refer back to their reference centers, or through the centers themselves.

Patients will undergo a screening visit, which will include a multi-faceted evaluation of cognitive function, physical and functional efficiency, and cardiovascular and cognitive decline risk factors. Procedures to be carried out during the screening visit include:

* Collection of socio-demographic data (age, sex, marital status, cohabitation, level of education, social interactions), clinical details (medical and medication history), and evaluation of inclusion/exclusion criteria
* Assessment of the degree of frailty through the Primary Care Frailty Index (PC-FI)
* Assessment of the presence of increased risk of developing dementia through the Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) score
* Assessment of cognitive performance through the General Practitioner assessment of COGnition (GPCOG)
* Assessment of cognitive performance through the Rey Auditory Verbal Learning Test - immediate
* Assessment of functional status by Short Physical Performance Battery (SPPB) tests
* Nonverbal interference tests
* Assessment of cognitive performance through the Rey Auditory Verbal Learning online version (RAVL-T delayed)
* Collection of self-administered scales for cognitive performance assessment through the Test Your Memory - Italian (TYM-I) scale.

Then, eligible patients will be enrolled for the second, active intervention phase of the study, which will include a baseline visit and 3 follow-up visits, at 6, 12, and 18 months.

During these visits, primary and secondary endpoint outcomes will be collected according to protocol.

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.

Primary outcomes:
measure: Modified Neuropsychological Test Battery (mNTB) score
timeFrame: The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6 follow up, Month 12 follow up, and Month 18 follow up. The tests take around 90 minutes overall.
Secondary outcomes:
measure: Short Physical Performance Battery (SPPB) score
timeFrame: The score will be taken at Day 0 Screening visit, at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.
measure: 4-m gait speed test - time
timeFrame: The test will be repeated at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.
measure: 4-m gait speed test - speed
timeFrame: The test will be repeated at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.
measure: Hand grip test
timeFrame: The test will be repeated at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.
measure: Activities of Daily Living (ADL) index score
timeFrame: The score will be taken at Day 0 Screening visit, at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups..
measure: Instrumental Activities of Daily Living (IADL) scale score
timeFrame: The score will be taken at Day 0 Screening visit, at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.
measure: Barthel Index score
timeFrame: The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.
measure: 14-item Resilience Scale (RS-14) score
timeFrame: The score will be taken at baseline, at Month 6, Month 12, and Month 18 follow-ups.
measure: Number of falls taken
timeFrame: Through study completion, an average of 2 years.
measure: Number of hospital admissions
timeFrame: Through study completion, an average of 2 years.
measure: Number of visits to general practitioner
timeFrame: Through study completion, an average of 2 years.
measure: Geriatric Depression Scale (GDS) score
timeFrame: The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.
measure: UCLA Loneliness Scale (UCLA-LS) score
timeFrame: The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.
measure: Psychological General Well Being Index (PGWBI) score
timeFrame: The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.
measure: World Health Organization Quality Of Life Questionnaire - Brief (WHO-QOL-Brief) score - Physical Health
timeFrame: The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.
measure: World Health Organization Quality Of Life Questionnaire - Brief (WHO-QOL-Brief) score - Psychological Health
timeFrame: The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.
measure: World Health Organization Quality Of Life Questionnaire - Brief (WHO-QOL-Brief) score - Social Relationships
timeFrame: The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.
measure: World Health Organization Quality Of Life Questionnaire - Brief (WHO-QOL-Brief) score - Environment
timeFrame: The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.
measure: World Health Organization Quality Of Life Questionnaire - Brief (WHO-QOL-Brief) score - Quality of Life
timeFrame: The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.
measure: World Health Organization Quality Of Life Questionnaire - Brief (WHO-QOL-Brief) score - Health Satisfaction
timeFrame: The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.
measure: Pittsburgh Sleep Quality Index (PSQI) score
timeFrame: The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.
measure: Mini Nutritional Assessment-Short Form (MNA-SF) score
timeFrame: The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.
measure: Mediterranean Diet Scale (MDScale) score
timeFrame: The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.
measure: Framingham Risk Score
timeFrame: The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.
measure: Cognitive Reserve Index questionnaire (CRIq) score
timeFrame: The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.
measure: Intrinsic Motivation Inventory (IMI) score
timeFrame: The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.
measure: Number of incidental diagnoses of Mild Cognitive Impairment (MCI) and dementia, according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria
timeFrame: Through study completion, an average of 2 years.
measure: Composite score of processing speed and attention
timeFrame: The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.
measure: Composite score of executive functions
timeFrame: The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.
measure: Composite memory score
timeFrame: The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.
measure: Composite language score
timeFrame: The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.
measure: Composite score of general cognitive assessment
timeFrame: The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.
Other outcomes:
Locations:
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori
Study officials:
References: