GOIZ ZAINDU Feasibility Multi Domain Trial to Prevent Dementia.

Cognitive Decline Clinical Trial

— GOIZ_ZAINDU  

Official title:

GOIZ ZAINDU Trial: a FINGER-like Multidomain Lifestyle Intervention Feasibility Study to Prevent Dementia in Southern Europe.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06163716
• Other study ID #: GZ trial
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: December 2023
• Source: Fundacion CITA-alzheimer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction
• Dementia
• Prevention

Intervention

Behavioral:
• Multidomain intervention (MD-Int) group
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.

Locations

Country	Name	City	State
Spain	CITA-alzheimer	Donostia-San Sebastián	Gipuzkoa

Sponsors (2)

Lead Sponsor	Collaborator
Fundacion CITA-alzheimer	Biogipuzkoa Health Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Global Cognitive performance	Cognitive performance was assessed at baseline and 12 months with the modified Neuropsychological Test Battery (NTBm) which includes the following test: Wechler Memory Scale-III Logical Memory, Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Word List, WMS-R Visual Paired Associates, Category Fluency, Wechler Adult Inteligence Scale-III Digit Span, Concept Shifting Test, Trail Making Test, a shortened 40-stimuli version of Stroop Test, and Letter Digit Substitution Test.	up to 1 year
Secondary	Performance in each cognitive domain	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.	up to 1 year