GOIZ ZAINDU Feasibility Multi Domain Trial to Prevent Dementia.

NCT06163716 | Completed DMC

• 1 other identifier: GZ trial
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Decline; Dementia Risk Factors; Prevention; Multidomain Intervention

Keywords

Cognitive decline; Dementia prevention; Lifestyle; Multidomain intervention; Randomized trial

Outcome Measures

Primary Outcomes (2)

• Retention rate

  Retention rate was defined as the proportion of participants who completed the 12-month trial period. We considered a successful rate if less than 20% of participants dropped out.

  up to 1 year

• Adherence to each intervention component

  Study coordinators assessed the adherence to intervention activities by recording the number of workshops and follow-up visits attended and by checking the cognitive training workbook. Self-reported information on weekly physical activity and attendance to group activities at the sports center was recorded for physical exercise.

  up to 1 year

Secondary Outcomes (2)

• Global Cognitive performance

  up to 1 year

• Performance in each cognitive domain

  up to 1 year

Study Arms (2)

Regular health advice control (RHA) group.

NO INTERVENTION

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.

Multidomain intervention (MD-Int) group

EXPERIMENTAL

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 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.

Behavioral: Multidomain intervention (MD-Int) group

Interventions

Multidomain intervention (MD-Int) group BEHAVIORAL

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.

Multidomain intervention (MD-Int) group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion CITA-alzheimer: lead
• Biogipuzkoa Health Research Institute: collaborator

Study Sites (1)

CITA-alzheimer

Donostia / San Sebastian, Gipuzkoa, 20009, Spain

Location

Related Publications (2)

• 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.

  PMID: 25771249 BACKGROUND

• Tainta M, Ecay-Torres M, de Arriba M, Barandiaran M, Otaegui-Arrazola A, Iriondo A, Garcia-Sebastian M, Estanga A, Saldias J, Clerigue M, Gabilondo A, Ros N, Mugica J, Barandiaran A, Mangialasche F, Kivipelto M, Arrospide A, Mar J, Martinez-Lage P; GOIZ ZAINDU study group. GOIZ ZAINDU study: a FINGER-like multidomain lifestyle intervention feasibility randomized trial to prevent dementia in Southern Europe. Alzheimers Res Ther. 2024 Feb 27;16(1):44. doi: 10.1186/s13195-024-01393-z.

  PMID: 38413990 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Mikel Tainta, MD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

• Pablo Martinez-Lage, MD, PhD

  Scientific Director

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: 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).

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 11, 2023
• Study Start: April 1, 2018
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

ES (1)