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

NCT06248723 | Recruiting

• 1 other identifier: IN TeMPO
• Study Type: interventional
• Target: 1,340
• Locations: 1 country
• Sites: 1

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.

Conditions

Age-related Cognitive Decline

Keywords

Cognitive decline; Dementia; Aging

Outcome Measures

Primary Outcomes (1)

• Modified Neuropsychological Test Battery (mNTB) score

  Participants will be scored through the mNTB to assess their cognitive state at baseline and cognitive changes at follow-ups. The mNTB score is a composite score for a battery of 14 tests total. The outcome measure is a z-score, it has no minimum or maximum value. A higher score means a better outcome.

  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 (32)

• Short Physical Performance Battery (SPPB) score

  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.

• 4-m gait speed test - time

  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.

• 4-m gait speed test - speed

  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.

• Hand grip test

  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.

• Activities of Daily Living (ADL) index score

  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..

Study Arms (2)

Active intervention arm

EXPERIMENTAL

* Physical exercise regime * Mediterranean diet-based nutritional plan * Cognitive training * Regular medical check-ups * Oral hygiene treatments and counseling * Counseling on sleep hygiene and treatment * Control of cardiovascular, metabolic, and infectious risk factors * Adjustment of drug therapy * Suggestions for improving social interactions Physical exercise and cognitive training interventions will be monitored and partially administered through wearable devices and digital tools. Sleep quality will be monitored through wearable devices. Social interactions will be encouraged through a validated app.

Other: Nutritional intervention; Other: Physical exercise; Other: Cognitive training; Other: Oral hygiene; Other: Sleep quality; Other: Control of cardiovascular, metabolic, and infectious risk factors; Other: Pharmacological evaluation; Behavioral: Socializing

Self-administered intervention arm

ACTIVE COMPARATOR

Subjects in the control group will receive regular health advice in the same domains as the intervention group, via dedicated app and/or access to the dedicated portal on the Age-It website. In addition, participants randomized to the self-guided intervention will receive an initial 30-60 minute counseling session on all domains covered by the study, in which guidelines for healthy diet, physical and cognitive activity, benefits of social activity, information on cardiovascular risk factors, as well as sleep, oral hygiene will be explained. Subjects will therefore be treated as per normal clinical practice, albeit with the help of dedicated apps and counseling session.

Other: Self-administered interventions

Interventions

Nutritional intervention OTHER

The objectives of the dietary intervention will be in accordance with the principles of the Mediterranean diet. Weekly menus will be provided that ensure a balanced intake of the various nutrients, according to the objectives outlined in the study protocol, including a reduction in saturated fatty acids (with proportionately more mono- and polyunsaturated fatty acids), promotion of fiber sources and reduction of sugars, adequate protein and micronutrient intake. They will be accompanied by specific dietary patterns that can be individualized based on weight, comorbidities and personal preferences. The need for weight loss or gain will be assessed on an individual basis. Dietary interventions will include group and individual sessions, and will be conducted by dietitians and nutritionists in a harmonized manner among the centers. The first meeting will be in-person and will be held at the subject's clinical center of enrollment. Follow-up will be conducted through online meetings.

Active intervention arm

Physical exercise OTHER

The physical activity protocol will be geared to the principles of progressive and individualized loading, in group sessions supervised by a physical therapist within gyms for the strength and balance training portion, and in moderate to intense aerobic activities based on individual preferences and characteristics. The physiotherapist will conduct an individual assessment and develop personalized programs for all participants. Exercise sessions will be held 2-3 times a week.

Active intervention arm

Cognitive training OTHER

Participants will be evaluated through a Cognitive and Psychological Assessment, which will allow measurement of each participant's cognitive functioning and well-being. Computerized cognitive training (CCT) using Brain HeadQuarter (BrainHQ) or similar software will be used as a cognitive intervention. The CCT includes game-based adaptive exercises that target attention, intelligence, memory, navigation, processing speed and social skills. The training will consist of 72 sessions for 24 weeks (about six months), at least three times a week.

Active intervention arm

Oral hygiene OTHER

Participants will be referred for evaluation at dental hygiene offices. As part of the study, participants will also undergo anticholinergic burden calculation, screening for risk factors for oral diseases (smoking, alcohol), and reduction in the frequency of sugar intake through dietary intervention will be sought. Participants will also undergo the Oral Health Assessment Tool rating scale.

Active intervention arm

Sleep quality OTHER

During the visits, participants' sleep will be assessed, either by clinical interview or by scales. Participants will also have the opportunity to assess their own sleep via wearable devices. If sleep hygiene issues are detected, advice based on currently available scientific evidence will be provided. If, on the other hand, a suspicion of sleep disorders, including, for example, obstructive sleep apnea syndrome, restless legs syndrome, insomnia, or Rapid Eye Movement (REM) sleep disorder, is raised from the medical history, participants will be referred to the relevant specialists for diagnosis and treatment of such problems.

Active intervention arm

Control of cardiovascular, metabolic, and infectious risk factors OTHER

Measurements of blood pressure, weight, BMI, abdominal circumference, and advice on health promotion and healthy lifestyle will be provided. Recommendations on adherence to the Piano Nazionale di Prevenzione Vaccinale (PNPV) will also be provided.

Active intervention arm

Pharmacological evaluation OTHER

Evaluation of prescriptive appropriateness (STOP\&START and Beers criteria) and calculation of anticholinergic burden (ACB calculator) will be carried out by a geriatrician, with rationalization of therapy and, where possible, de-prescribing.

Active intervention arm

Socializing BEHAVIORAL

To encourage socialization, proposed activities will be carried out as much as possible in groups of 10-12 people, and outdoor group activities will be suggested on a biweekly basis (e.g., walks in parks). On a monthly basis, the nurse and psychologist will organize motivational and check-up meetings (in recreation centers/via telematics) in order to promote adherence to the protocol, collect questions and stimulate participants. Social activity will also be implemented in the context of all interventions, for example through: * Physical activity in groups or pairs, including dance or choir activities where possible * Opportunities for further cognitive stimulation in groups through games (e.g., chess, cards, etc.) * Proposal to cook, eat or shop together * Group sessions with dietitian

Active intervention arm

Self-administered interventions OTHER

Subjects in the control group will receive regular health advice in the same domains as the intervention group, via dedicated app and/or access to the dedicated portal on the Age-It website. Such advice and information will be timed to encourage adherence. In addition, participants randomized to the self-guided intervention will receive an initial counseling session of 30-60 minutes on all domains covered by the study, where guidelines for healthy diet, physical and cognitive activity, benefits of social activity, information on cardiovascular risk factors, as well as sleep, oral hygiene will be explained. Subjects will therefore be treated as per normal clinical practice, albeit with the help of dedicated apps and counseling session.

Self-administered intervention arm

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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, with Lifestyle Index ≥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 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

You may not qualify 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 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.

Sponsors & Collaborators

• University of Milano Bicocca: lead
• European Union: collaborator

Study Sites (1)

Fondazione IRCCS San Gerardo dei Tintori

Monza, Italy

RECRUITING

Related Publications (1)

• Sala G, Cuffaro L, Pozzi FE, Andreoni S, Bazzini C, Conti E, Zoia CP, Beretta S, Tremolizzo L, Bellelli G, Okoye C, Ferrara MC, De Luca A, Lenti R, Mantuano P, Pontrelli P, Stasi A, Defazio G, Solfrizzi V, Crudele L, Airoldi C, Chiaradonna F, Longhese MP, Messina G, Natalello A, Orlandi I, Aloisi A, Capone S, Ingannato A, Nacmias B, Capello D, Mangialasche F, Ferrarese C. Multi-pathway blood biomarkers to target and monitor multidimensional prevention of cognitive and functional decline (nested in the IN-TeMPO study framed within the world-wide FINGERS network). Front Aging Neurosci. 2025 May 7;17:1581892. doi: 10.3389/fnagi.2025.1581892. eCollection 2025.

  PMID: 40400914 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia

Interventions

Exercise; Cognitive Training; Oral Hygiene; Metabolic Networks and Pathways

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Hygiene; Preventive Dentistry; Dentistry; Metabolism

Central Study Contacts

Carlo Ferrarese

CONTACT

0392333595; carlo.ferrarese@unimib.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patients are randomized 1:1 into "active intervention" and "self-guided intervention" parallel groups.

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: February 8, 2024
• Study Start: July 16, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-07

Locations

IT (1)