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ItaliaN Study With Tailored Multidomain Interventions to Prevent Functional and Cognitive Decline in Community-dwelling Older Adults (IN TeMPO)
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.
Details
| Lead sponsor | University of Milano Bicocca |
|---|---|
| Phase | NA |
| Status | RECRUITING |
| Enrolment | 1340 |
| Start date | 2024-07-16 |
| Completion | 2026-03 |
Conditions
- Age-related Cognitive Decline
Interventions
- Nutritional intervention
- Physical exercise
- Cognitive training
- Oral hygiene
- Sleep quality
- Control of cardiovascular, metabolic, and infectious risk factors
- Pharmacological evaluation
- Socializing
- Self-administered interventions
Primary outcomes
- Modified Neuropsychological Test Battery (mNTB) score — 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.
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.
Countries
Italy