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NCT Number: NCT04840030

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

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.

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Key information

Conditions

Dementia Behavior Behavior, Animal Behavioral Intervention Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Decline Cognitive Dysfunction Cognitive Intervention Diet Habit Feeding Behavior Life Style Mental Disorders Nervous System Diseases Neurocognitive Disorders Prevention Risk Factor, Cardiovascular

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CITA-alzheimer

Donostia / San Sebastian, Gipuzkoa, 20009, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multimodal intervention (MM-int)

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

Primary outcomes

  1. Global Cognitive performance

    Time frame: up to 2 years

    Cognitive performance will be assessed with the Neuropsychological Test Battery modified (NTBm) (Harrison J. et aet al.ch Neurol 2007).

    The NTBm consists of 9 validated components:NTBm Cognitive global, executive function, memory, processing speed scores will be obtained. Composite cognitive z-scores based on the results from all single tests will be calculated. Single z-scores will be calculated using baseline mean and standard deviations of the study sample and, for each composite score, single z-scores will be averaged. Higher scores suggest better performance.

Secondary outcomes

  1. Performance in each cognitive domain

    Time frame: up to 2 years

    NTBm Cognitive global, executive function, memory, processing speed scores will be obtained. Composite cognitive z-scores based on the results from all single tests will be calculated. Single z-scores will be calculated using baseline mean and standard deviations of the study sample and, for each composite score, single z-scores will be averaged. Higher scores suggest better performance.

    b. Change in specific cognitive domains will be assessed by the difference in pre-and postintervention scores in episodic memory, executive function and processing speed and visuospatial function z-scores.

  2. Incremental Cost-Utility Ratio (ICUR)

    Time frame: up to 2 years

    To estimate the cost-effectiveness of the intervention program the Incremental Cost-Utility Ratio (ICUR) between muntidomain intervention group and regular health advice group.

    The incremental cost-utility ratio (ICUR) will be estimated by dividing incremental cost (Ca-Cb) by incremental utility (Ua-Ub). The time horizon was the patient's lifetime. A 3% discount rate will be applied to costs and effectiveness. Since the main economic impact of dementia is related to the care required as patients become dependent, a societal perspective will be used.

  3. Amsterdam questionnaire for Instrumental Activities of Daily Living (A-IADL-Q)

    Time frame: up to 2 years

    The Amsterdam IADL Questionnaire (A-IADL-Q) is an adaptive and computerized questionnaire designed to assess impairments in instrumental activities of daily living (IADL) in (early) dementia. The questionnaire is completed by a caregiver, such as a relative or friend. (Sikkes SA et al. 2012).

  4. Change in perceived Quality of life - EQ-D-5L scale

    Time frame: up to 2 years

    The EQ-5D-5L (Herdman M. et al. 2011) essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).

    The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension.

    The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.

  5. Depressive and anxiety sympthoms. Hospital Anxiety and Depression Scale (HADS)

    Time frame: up to 2 years

    HADS was originally developed by Zigmond and Snaith (1983) and is commonly used to determine the levels of anxiety and depression that a person is experiencing. The HADS is a fourteen-item scale that generates: Seven of the items relate to anxiety and seven relate to depression.

  6. Change in cognitive performance in different groups of patients with the same APOE status

    Time frame: up to 2 years

    To assess whether differences between intervention groups concerning the primary and secondary cognitive outcomes vary among subgroups defined by APOE status as a genetic condition.

Sponsors and collaborators

Lead sponsor

Fundacion CITA-alzheimer

Other

Collaborators

  • Achucarro Basque Center For Neuroscience
  • Basque Culinary Center Fundazioa
  • Biogipuzkoa Health Research Institute
  • Karolinska Institutet
  • NavarraBiomed Biomedical Research Center
  • University of the Basque Country (UPV/EHU)

Registry information

Official study title

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

Acronym: CITA GO-ON

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2021
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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