Clinical trial NCT06163716: GOIZ ZAINDU Feasibility Multi Domain Trial to Prevent Dementia.
Official title: GOIZ ZAINDU Trial: a FINGER-like Multidomain Lifestyle Intervention Feasibility Study to Prevent Dementia in Southern Europe.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Decline
Dementia Risk Factors
Prevention
Multidomain Intervention
Keywords: Cognitive decline
Dementia prevention
Lifestyle
Multidomain intervention
Randomized trial
Lead sponsor: Fundacion CITA-alzheimer
Sponsor class: OTHER
Collaborators: name: Biogipuzkoa Health Research Institute
First posted: 2023-12-11
Enrollment: 125
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The GOIZ ZAINDU pilot trial is a one-year controlled, randomized, multidomain intervention trial, for prevention of cognitive decline, carried out in the municipality of Beasain in the Basque Country (Spain).
Primary purpose: PREVENTION

Brief summary: GOIZ ZAINDU ("caring early" in Basque) is a pilot study to adapt the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) methodology to the Basque population and evaluate feasibility and adherence to a FINGER-like multidomain intervention program. Additional aims included the assessment of efficacy on cognition and collecting data to design a large efficacy trial.

Detailed description: The GOIZ ZAINDU pilot trial is a one-year controlled, randomized, multidomain intervention trial, for prevention of cognitive decline, carried out in the municipality of Beasain in the Basque Country (Spain). Participants were recruited in collaboration with the primary care center health providers from Beasain Municipality after an informative prevention campaign on lifestyle and dementia.

After the baseline evaluation, all participants received in person verbal information on the potential benefits of caring for vascular risk factors, adhering to Mediterranean diet, and having good cognitive and physical activity routines. Participants were later randomly assigned to a standard health advice control group (RHA, control) or the multidomain intervention group (MD-Int). Random assignment followed a proportion of 1:1 and was stratified by age (\<75 years vs.≥75 years), sex, and cognitive status (normal cognition vs. MCI).

1. Regular health advice control (RHA) group. Participants randomized to the control group followed preventive programs already ongoing at their Primary Care Unit regarding physical activity, socialization, and smoking and alcohol usage. Visits to the GP and nurse depended on personal demands and necessities; nevertheless, annual consultation was recommended for all patients over 60 years old.
2. Multidomain intervention (MD-Int) group. The MD-Int program was designed to provide tools and routines that participants could incorporate into daily living activities and reinforce the social environment. Although the program included standardized guidelines and exercises, each participant was considered individually, adapting nutritional requirements and physical and cognitive activity according to individual needs and abilities. This methodology is based on the FINGER trial design\[23\] but has been adapted to local resources and the healthcare system. GPs and nurses were involved in the follow-up visits. Most intervention activities were carried out at the local Primary Care Centre. Local town hall resources such as group activities for older adults at the municipality sports centre and current outdoor sports activities were incorporated in the study. The MD-Int program included: 1) individual follow-up visits every three months for cardiovascular risk factor monitoring and nutritional counselling with primary health care providers; 2) two nutritional workshops led by a nutritionist; 3) 20 hours of cognitive stimulation delivered through group sessions and 4) 40 hours of individual cognitive training exercises. Participants in the MD-Int group received recommendations to practice 2 to 6 hours of physical exercise per week and get involved in sports activities. Social stimulation was promoted through group activities.

Eligibility criteria: Inclusion Criteria:

* Participants were at least 60 years of age,
* had a CAIDE score ≥ 6 points and
* performed below than expected in at least one of two brief cognitive tests - Memory alteration test (T@M) and Fototest
* or scored two or higher in the AD8 informant's questionnaire of cognitive symptoms.

Exclusion Criteria:

* Exclusion criteria included the presence of poorly controlled cardiovascular or respiratory disease,
* previous diagnosis of dementia, ongoing neurological disorders, unstable psychiatric disease, evidence of any other severe disease of any etiology,
* or any situation, in the investigator's opinion, that could compromise safe engagement in the intervention.

Primary outcomes:
measure: Retention rate
timeFrame: up to 1 year
measure: Adherence to each intervention component
timeFrame: up to 1 year
Secondary outcomes:
measure: Global Cognitive performance
timeFrame: up to 1 year
measure: Performance in each cognitive domain
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Donostia-San Sebastián
country: Spain
facility: CITA-alzheimer
state: Gipuzkoa
Study officials:
affiliation: Study 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.