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

NCT ID: NCT04840030

Last Updated: 2023-02-16

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 1094 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-03
• Study Completion Date: 2026-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Standard health advice (SHA-control)

The participant will receive verbal information of risk factors and information, reassessment, and written materials regarding approved recommendations on active and healthy aging on topics such as diet, physical activity, cognitive training as well as risk factor control following the state of the art and published guidelines by the Department of Health of the Basque Government/ Basque Country Public Health System (Osakidetza) and the WHO (Guidelines for risk reduction of cognitive decline and Dementia and the "Guidance on person-centered assessment and pathways in primary care - ICOPE"). Participants in this group will receive the best standard health care from their primary care and specialist health teams according to already established routines as well as usual social services assessments and care as needed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Multidomain intervention (MM-Int)

Participants in this group will receive the same verbal and written recommendations as to the ones in the SHA-Control group but then they will perform a 2 year structured program with periodic individual and group visits regarding 1) Risk factor control (vascular factors, polypharmacy); 2) Cognitive training, 3) Physical activity, 4) Dietary changing program and 5) emotional counseling and social engagement.

Group Type: EXPERIMENTAL

Multimodal intervention (MM-int)

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. People between 60-85 years old, willing to participate and comply with all the study evaluation and intervention procedures.

2. With a CAIDE dementia Risk score ≥ 6

3. Below-than-expected cognitive performance in at least one of three brief cognitive tests:

• Fototest score ≤ 35
• Memory Alteration Test -T@M score ≤40
• Cognitive complaints as compared with a previous subjective performance - defined by a Cognitive Change Index - self-report version score >=20 on the first 12 (episodic memory) items to assist with defining Subjective Cognitive Decline (SCD) (Risacher et al. 2017).

Exclusion Criteria

1. Inability to perform a neuropsychological evaluation or a cognitive stimulation program (sensory limitation, mental retardation, illiteracy)

2. Barthel index < 90.

3. Geriatric Depression Scale ≥ 9

4. Dementia or Moderate Cognitive impairment (MMSE < 20).

5. Presence of any neurological, psychiatric or systemic disease that produce cognitive impairment or dementia including, but not limited to, Huntington's disease, multiple sclerosis, Parkinson's disease, Down syndrome, alcohol abuse or active drugs, or major psychiatric disorders including ongoing major depression, schizophrenia or bipolar or schizoaffective disorder.

6. Unstable ischemic cardiopathy, uncontrolled heart arrhythmia, thromboembolic disease in the last year. Moderate cardiorespiratory insufficiency (including Class III or IV congestive heart failure, clinically significant aortic stenosis, cardiac arrest history, or uncontrolled angina). Currently receiving physical therapy or cardiopulmonary rehabilitation.

7. Large vessel stroke in the past two years

8. History of transient ischemia attack (TIA) or small vessel stroke in the last 6 months

9. Any cerebrovascular accident with significant residual effects on cognition or functional autonomy.

10. History within the last 2 years of treatment for primary or recurrent malignant disease, excluding non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or situ prostate cancer with normal prostate-specific antigen posttreatment

11. Recent (< 3 months) bone fracture.

12. History of hip fracture, joint replacement, or spinal surgery in the last 6 months

13. Clinically significant abnormalities in laboratory blood tests as per judgment of the site Study Clinician

14. Any conditions affecting safe engagement in the intervention in the judge of the study investigators.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biogipuzkoa Health Research Institute

OTHER

Sponsor Role: collaborator

University of the Basque Country (UPV/EHU)

OTHER

Sponsor Role: collaborator

Achucarro Basque Center For Neuroscience

UNKNOWN

Sponsor Role: collaborator

NavarraBiomed Biomedical Research Center

OTHER

Sponsor Role: collaborator

Basque Culinary Center Fundazioa

OTHER

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Fundacion CITA-alzheimer

OTHER

Sponsor Role: lead

Responsible Party

Mikel Tainta

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mikel Tainta, MD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Pablo Martinez-Lage, MD PhD

Role: STUDY_CHAIR

Scientific Director

Locations

CITA-alzheimer

Donostia / San Sebastian, Gipuzkoa, Spain

Countries

Spain

References

Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.

Reference Type: BACKGROUND

PMID: 25771249 (View on PubMed)

Other Identifiers

Go-on_studyprotocol_v3_apr20

Identifier Type: -

Identifier Source: org_study_id