Actively Recruiting
Exercogs4 Efficacy of a Multidomain Digital Therapeutic Solution for Preventing Cognitive Decline in Adults Aged 6555 With Modifiable Risk Factors - Randomized Controlled Trial
Led by Eduarda Oliosi, MS · Updated on 2026-04-15
150
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
Sponsors
E
Eduarda Oliosi, MS
Lead Sponsor
V
Value for Health CoLAB
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the feasibility, safety, and efficacy of Exercogs4, a novel exergaming platform combining augmented reality AR and gamification, as part of a community-based dementia prevention program for older adults at risk. The study focuses on adults aged 55 years or older who have at least one modifiable dementia risk factor, assessing effects on cognitive, physical, and social domains. It is a randomized, controlled, assessor-blind, parallel-group, multicenter trial designed to provide robust evidence for digital multidomain interventions in dementia prevention. Participants will be randomly assigned to either the Exercogs4 intervention group or an active control group. Both groups will engage in supervised 60-minute sessions three times per week for 24 weeks. The Exercogs4 program integrates cognitive exercises attention, memory, executive function, physical training balance, gait, coordination, and social activities cooperative and competitive tasks within a gamified AR environment with adaptable difficulty. The control group will perform similar multidomain exercises without AR or gamification. Assessments occur at baseline, 12 weeks, 24 weeks end of intervention, and 4 and 8 weeks post-intervention. Participants will undergo comprehensive evaluations including cognitive testing MoCA, physical performance SPPB, and social participation WHODAS 2.0. Additional measures include usability, quality of life, safety monitoring for adverse events, and modifiable risk factor changes. Adherence is tracked through automated logs and therapist diaries. The study duration includes the 24-week intervention plus follow-up assessments, aiming to gather evidence on the usability, safety, and potential benefits of this multidomain digital therapeutic approach for dementia prevention.
CONDITIONS
Brief Title
The Exercogs® Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 55 years or older
- Presence of at least one modifiable dementia risk factor such as low education, untreated hearing or visual loss, hypertension, obesity, smoking, depression, physical inactivity, type 2 diabetes, social isolation, excessive alcohol consumption, history of head trauma, air pollution exposure, or high LDL/dyslipidemia
- Ability and willingness to participate in 60-minute sessions three times per week for 24 weeks
- Ability to provide written informed consent or consent from a legally authorized representative if decisional capacity is reduced
You will not qualify if you...
- Clinical diagnosis of Alzheimer's disease or dementia
- Severe neurological disorder or unstable medical condition that may interfere with participation
- Sensory or language deficits preventing understanding of instructions or safe participation
- Current participation in another interventional study that may affect outcomes
- Previous experience with Exercogs4
Research Team
C
Carla Pombo (Coordinator Nurse and Principal Investigator)
E
Eduarda Oliosi (Biomedical Scientist)
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