Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06163716
Other study ID # GZ trial
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT03228446 - The Effects of Attentional Filter Training on Working Memory N/A
Completed NCT04033419 - Memantine for Prevention of Cognitive Decline in Patients With Breast Cancer Phase 2
Terminated NCT05199142 - A Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of SDI-118 in Elderly Male and Female Study Participants With Cognitive Decline Phase 1
Active, not recruiting NCT05290233 - Time Restricted Eating Plus Exercise for Weight Management N/A
Terminated NCT03337282 - Incidence and Characteristics of Postoperative Cognitive Dysfunction in Elderly Quebec Francophone Patients
Unknown status NCT00696514 - Vitamin B12 and Folic Acid Supplementation for Preventing Fractures in Elderly People Phase 1
Completed NCT00110604 - The Effect of Folic Acid on Atherosclerosis, Cognitive Performance and Hearing N/A
Recruiting NCT06245005 - Preoperative Cognitive Reserve in Older Surgical Patients: A Feasibility Study
Recruiting NCT05014399 - Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy
Active, not recruiting NCT05586750 - Statins in Reducing Events in the Elderly Mind (STAREE-Mind) Imaging Substudy Phase 4
Completed NCT04386902 - Evaluation of Cognitive State Using Neurosteer EEG System
Recruiting NCT06070818 - Healthy Body & Mind Program for Older Adults Living With Osteoarthritis and Cognitive Decline N/A
Completed NCT01669915 - A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline N/A
Completed NCT02814526 - Exercise in Adults With Mild Memory Problems N/A
Not yet recruiting NCT06252376 - Effects of Blood Pressure on Cognition and Cerebral Hemodynamics in PD N/A
Not yet recruiting NCT05928078 - A Home-based e-Health Intervention in the Elderly: MOVI-ageing N/A
Recruiting NCT06318377 - Peanuts and Neurocognitive / Cardiovascular Health in Black Individuals N/A
Recruiting NCT03839784 - Building a Platform for Precision Anesthesia in the Geriatric Surgical Patient
Completed NCT04537728 - My Healthy Brain: Preserving and Promoting Brain Health Through Evidence-based Practices N/A
Active, not recruiting NCT03370796 - Group Reminiscence Therapy for Elderly People With Cognitive Decline in Institutional Context N/A