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

Official title

Effectiveness of a Lifestyle Multidomain Intervention to Prevent Cognitive Decline in the Basque Country. GOIZ ZAINDU Gipuzkoa - CITA GO-ON Study

Overview

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.

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 objectiv

Primary outcome measures

• Global Cognitive performance [Time frame: up to 2 years]

Secondary outcome measures (6)

• Performance in each cognitive domain [Time frame: up to 2 years]
• Incremental Cost-Utility Ratio (ICUR) [Time frame: up to 2 years]
• Amsterdam questionnaire for Instrumental Activities of Daily Living (A-IADL-Q) [Time frame: up to 2 years]
• Change in perceived Quality of life - EQ-D-5L scale [Time frame: up to 2 years]
• Depressive and anxiety sympthoms. Hospital Anxiety and Depression Scale (HADS) [Time frame: up to 2 years]
• Change in cognitive performance in different groups of patients with the same APOE status [Time frame: up to 2 years]

Eligibility criteria

Inclusion criteria

• People between 60-85 years old, willing to participate and comply with all the study evaluation and intervention procedures.
• With a CAIDE dementia Risk score ≥ 6
• 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

Exclusion criteria are conditions that may affect the achievement of study objectives and procedures or clinical diagnoses that by themselves compromise participant's cognitive performance or compliance with study procedures. They include:

• Inability to perform a neuropsychological evaluation or a cognitive stimulation program (sensory limitation, mental retardation, illiteracy)
• Barthel index < 90.
• Geriatric Depression Scale ≥ 9
• Dementia or Moderate Cognitive impairment (MMSE < 20).
• 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.
• 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.
• Large vessel stroke in the past two years
• History of transient ischemia attack (TIA) or small vessel stroke in the last 6 months
• Any cerebrovascular accident with significant residual effects on cognition or functional autonomy.
• 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
• Recent (< 3 months) bone fracture.
• History of hip fracture, joint replacement, or spinal surgery in the last 6 months
• Clinically significant abnormalities in laboratory blood tests as per judgment of the site Study Clinician
• Any conditions affecting safe engagement in the intervention in the judge of the study investigators.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Prevention

Study locations

Spain · 1 center

• CITA-alzheimer — Donostia / San Sebastian

Publications

• 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 cog PMID 25771249

Identifiers

NCT: NCT04840030 · Go-on_studyprotocol_v3_apr20

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗