Preventing Cognitive Decline: The CITA GO-ON Multi-domain Intervention Study

Summary

The GOIZ ZAINDU Gipuzkoa - GO - ON Study is an intervention trial to evaluate the efficacy of dementia prevention strategies in cognitively frail people. It is a large-scale randomized controlled trial in over 1000 older adults between 60 and 85 years old with increased CAIDE risk score (≥6), non-demented but with low performance in at least one of three brief cognitive tests. Participants will be randomized to receive standard health advice (SHA-control) or a multidomain intervention (MM-Int) consisting of 1) Risk factor control (vascular factors, polypharmacy); 2) Cognitive training, 3) Physical activity, 4) Dietary changing program, and 5) emotional counseling and social engagement.

The primary aim is to demonstrate a 20% reduction in the proportion of subjects who decline in their NTB performance (z score) after 24 months in the intervention group compared to the controls.

Secondary aims include: 1) Analyze cost-effectiveness; 2) Show a beneficial effect of the intervention on functional abilities, quality of life, and depressive and anxiety symptoms; 3) Investigate the impact of a lifestyle intervention on aging. In this sense, biological samples and neuroimaging studies will be collected to allow exploratory investigations on aging mechanisms, amyloid imbalance, tau pathology, epigenetics, neuroinflammation, vascular dysfunction, lipid dysregulation, white matter disintegration, cognitive and brain reserve.

This protocol is participant-centered, empowering citizens since the recruitment process to gain access to knowledge about their dementia risk status via web or by phone and then decide to participate. Intervention activities have also taken into account participants' perspective with the design of easy-to-use and appealing activities (e.g., using a self-administered at-home physical activity program such as VIVIFRAIL© and EXERCITA© cognitive training materials that have been developed, taking into account the Basque Country population's cultural, linguistic and educational particularities; and diet and nutritional workshops with famous chefs to learn innovative and attractive healthy recipes).

The GO-ON trial may shed light on the tools that people need to fulfill the expectation of an active, healthy dementia-free aging. These include digital tools that in the COVID19 pandemic have shown to be effective in removing distance barriers. GO-ON uses them to give support and expand the possibilities to clinical assessment settings and intervention delivery. The digital part of the intervention may expand preventive actions to small rural areas, including digital socialization.

GO-ON Study, which starts in summer 2021, is the first large-scale lifestyle intervention trial in Southern Europe that takes part in the WORLDWIDE FINGERs network and will help answer whether the FINGER results can be replicated. The intervention design has been made on the basis that if proven to be efficacious, it may be easily applied at a Public System-level to guarantee a rapid and easy translation of research results to Primary Care settings and people homes.

Conditions

• Dementia
• Cognitive Decline
• Prevention
• Life Style
• Risk Factor, Cardiovascular
• Diet Habit
• Cognitive Intervention
• Behavioral Intervention

Interventions

BEHAVIORAL

Multimodal intervention (MM-int)

1. Cognitive intervention objective: To enhance cognitive functioning and incorporate daily habits and routines that are cognitively stimulating 2. Socio-emotional intervention objective: • Promote socio-emotional skills associated with awareness, communication and regulation of emotions in late life. 3. Nutritional intervention objective: To improve eating habits of participants to be based on the Mediterranean Dietary pattern by an educational program 4. Physical activity intervention objective: To improve aerobic capacity y, decrease the risk of falls, and improve static and dynamic balance. 5. Risk factors and comorbidities monitoring intervention: quarterly scheduled visits for a cardiovascular risk factors check-up and review active medication

Sponsors & Collaborators

• Biogipuzkoa Health Research Institute

  collaborator OTHER

• University of the Basque Country (UPV/EHU)

  collaborator OTHER

• Achucarro Basque Center For Neuroscience

  collaborator UNKNOWN

• NavarraBiomed Biomedical Research Center

  collaborator OTHER

• Basque Culinary Center Fundazioa

  collaborator OTHER

• Karolinska Institutet

  collaborator OTHER

• Fundacion CITA-alzheimer

  lead OTHER

Principal Investigators

• Mikel Tainta, MD · Principal Investigator

• Pablo Martinez-Lage, MD PhD · Scientific Director

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-12-03

Primary Completion

2026-09-30

Completion

2026-09-30

Countries

• Spain

Study Locations