Cognitive DeclineGOIZ_ZAINDUNCT06163716
GOIZ ZAINDU Feasibility Multi Domain Trial to Prevent Dementia.
A study testing Multidomain intervention (MD-Int) group in people with Cognitive Decline and Dementia Risk Factors, run by Fundacion CITA-alzheimer at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline, Dementia Risk Factors, Prevention
- What is being tested?
- Multidomain intervention (MD-Int) group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2018to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GOIZ ZAINDU Trial: a FINGER-like Multidomain Lifestyle Intervention Feasibility Study to Prevent Dementia in Southern Europe.
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.
Read the 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).
- 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.
- 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.
- Being tested
- Multidomain intervention (MD-Int) group
- Keywords
- Cognitive decline, Dementia prevention, Lifestyle, Multidomain intervention, Randomized trial
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidomain intervention (MD-Int) groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Multidomain intervention (MD-Int) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 1 year
Secondary outcomes (2)
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.
Measured: up to 1 year
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.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start1 Apr 2018
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion CITA-alzheimer
- Sponsor type
- University, hospital or other
- Collaborators
- Biogipuzkoa Health Research Institute
- Responsible party
- Principal investigator, Mikel Tainta, Fundacion CITA-alzheimer
- Investigators
- Mikel Tainta, MD, Principal investigator, Study Principal InvestigatorPablo Martinez-Lage, MD, PhD, Study chair, Scientific Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163716
- Sponsor's protocol ID
- GZ trial
- Acronym
- GOIZ_ZAINDU
- Status last verified
- Dec 2023
- First submitted
- 23 Nov 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Consent for publication. All participants signed the corresponding informed consent which included an explicit consent for publication the study results and experience. Availability of data and materials. The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Publications
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.
PubMed 25771249Tainta 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.
PubMed 38413990
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GOIZ ZAINDU Trial: a FINGER-like Multidomain Lifestyle Intervention Feasibility Study to Prevent Dementia in Southern Europe.
- ClinicalTrials.gov ID
- NCT06163716
- Acronym / sponsor ID
- GOIZ_ZAINDU / GZ trial
- Keywords
- Cognitive decline, Dementia prevention, Lifestyle, Multidomain intervention, Randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Fundacion CITA-alzheimerUniversity, hospital or other
- Collaborators
- Biogipuzkoa Health Research Institute
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Multidomain intervention (MD-Int) groupThe 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidomain intervention (MD-Int) groupThe 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. | Behavioural | Multidomain intervention (MD-Int) group |
Primary outcome
Retention rate
Time frame: up to 1 year
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.
Adherence to each intervention component
Time frame: up to 1 year
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.
2 secondary outcomes
Global Cognitive performance
Time frame: up to 1 year
Performance in each cognitive domain
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Background: PubMed 25771249Ngandu 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.
- Derived from this study: PubMed 38413990Tainta 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.
- Individual participant dataSharing planned: Yes. Consent for publication. All participants signed the corresponding informed consent which included an explicit consent for publication the study results and experience. Availability of data and materials. The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikel Tainta, MD principal investigator
Study Principal Investigator
Pablo Martinez-Lage, MD, PhD study chair
Scientific Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidomain intervention (MD-Int) group in people with Cognitive Decline and Dementia Risk Factors, run by Fundacion CITA-alzheimer at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention rate (time frame: up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06163716, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.