Clinical trial NCT04840030: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Dementia
Cognitive Decline
Prevention
Life Style
Risk Factor, Cardiovascular
Diet Habit
Cognitive Intervention
Behavioral Intervention
Lead sponsor: Fundacion CITA-alzheimer
Sponsor class: OTHER
Collaborators: name: Biogipuzkoa Health Research Institute
name: University of the Basque Country (UPV/EHU)
name: Achucarro Basque Center For Neuroscience
name: NavarraBiomed Biomedical Research Center
name: Basque Culinary Center Fundazioa
name: Karolinska Institutet
First posted: 2021-04-09
Enrollment: 1094
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The Gipuzkoa GOIZ ZAINDU - GO-ON study is a two year randomized, controlled trial to evaluate the effectiveness of multi-component lifestyle and dementia risk factor intervention in preventing cognitive decline in older adults with cognitive frailty.
Primary purpose: PREVENTION

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.


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:

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:

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.

Primary outcomes:
measure: Global Cognitive performance
timeFrame: up to 2 years
Secondary outcomes:
measure: Performance in each cognitive domain
timeFrame: up to 2 years
measure: Incremental Cost-Utility Ratio (ICUR)
timeFrame: up to 2 years
measure: Amsterdam questionnaire for Instrumental Activities of Daily Living (A-IADL-Q)
timeFrame: up to 2 years
measure: Change in perceived Quality of life - EQ-D-5L scale
timeFrame: up to 2 years
measure: Depressive and anxiety sympthoms. Hospital Anxiety and Depression Scale (HADS)
timeFrame: up to 2 years
measure: Change in cognitive performance in different groups of patients with the same APOE status
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Donostia-San Sebastián
country: Spain
facility: CITA-alzheimer
state: Gipuzkoa
Study officials:
affiliation: Principal Investigator
name: Mikel Tainta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Scientific Director
name: Pablo Martinez-Lage, MD PhD
role: STUDY_CHAIR
References:
citation: 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.