DementiaCITA GO-ONNCT04840030
Preventing Cognitive Decline: The CITA GO-ON Multi-domain Intervention Study
A study testing Multimodal intervention (MM-int) in people with Dementia and Cognitive Decline, run by Fundacion CITA-alzheimer at 1 site in Spain.
Trial summary
The GOIZ ZAINDU Gipuzkoa - GO - ON Study is an intervention trial to evaluate the efficacy of dementia prevention strategies in cognitively frail people. It is a large-scale randomized controlled trial in over 1000 older adults between 60 and 85 years old with increased CAIDE risk score (≥6), non-demented but with low… Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia, Cognitive Decline, Prevention
- What is being tested?
- Multimodal intervention (MM-int)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,094 participants
- Where
- 1 siteSpain
- Study dates
- 3 Dec 2021to 30 Sep 2026
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- People between 60-85 years old, willing to participate and comply with all the study evaluation and intervention procedures.
- With a CAIDE dementia Risk score ≥ 6
- Below-than-expected cognitive performance in at least one of three brief cognitive tests:
- Fototest score ≤ 35
- Memory Alteration Test -T@M score ≤40
- Cognitive complaints as compared with a previous subjective performance - defined by a Cognitive Change Index - self-report version score >=20 on the first 12 (episodic memory) items to assist with defining Subjective Cognitive Decline (SCD) (Risacher et al. 2017).
Who cannot join
- Exclusion criteria are conditions that may affect the achievement of study objectives and procedures or clinical diagnoses that by themselves compromise participant's cognitive performance or compliance with study procedures. They include:
- Inability to perform a neuropsychological evaluation or a cognitive stimulation program (sensory limitation, mental retardation, illiteracy)
- Barthel index < 90.
- Geriatric Depression Scale ≥ 9
- Dementia or Moderate Cognitive impairment (MMSE < 20).
- Presence of any neurological, psychiatric or systemic disease that produce cognitive impairment or dementia including, but not limited to, Huntington's disease, multiple sclerosis, Parkinson's disease, Down syndrome, alcohol abuse or active drugs, or major psychiatric disorders including ongoing major depression, schizophrenia or bipolar or schizoaffective disorder.
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- Unstable ischemic cardiopathy, uncontrolled heart arrhythmia, thromboembolic disease in the last year. Moderate cardiorespiratory insufficiency (including Class III or IV congestive heart failure, clinically significant aortic stenosis, cardiac arrest history, or uncontrolled angina). Currently receiving physical therapy or cardiopulmonary rehabilitation.
- Large vessel stroke in the past two years
- History of transient ischemia attack (TIA) or small vessel stroke in the last 6 months
- Any cerebrovascular accident with significant residual effects on cognition or functional autonomy.
- History within the last 2 years of treatment for primary or recurrent malignant disease, excluding non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or situ prostate cancer with normal prostate-specific antigen posttreatment
- Recent (< 3 months) bone fracture.
- History of hip fracture, joint replacement, or spinal surgery in the last 6 months
- Clinically significant abnormalities in laboratory blood tests as per judgment of the site Study Clinician
- Any conditions affecting safe engagement in the intervention in the judge of the study investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Lifestyle Multidomain Intervention to Prevent Cognitive Decline in the Basque Country. GOIZ ZAINDU Gipuzkoa - CITA GO-ON Study
The GOIZ ZAINDU Gipuzkoa - GO - ON Study is an intervention trial to evaluate the efficacy of dementia prevention strategies in cognitively frail people. It is a large-scale randomized controlled trial in over 1000 older adults between 60 and 85 years old with increased CAIDE risk score (≥6), non-demented but with low performance in at least one of three brief cognitive tests. Participants will be randomized to receive standard health advice (SHA-control) or a multidomain intervention (MM-Int) consisting of 1) Risk factor control (vascular factors, polypharmacy); 2) Cognitive training, 3) Physical activity, 4) Dietary changing program, and 5) emotional counseling and social engagement.
The primary aim is to demonstrate a 20% reduction in the proportion of subjects who decline in their NTB performance (z score) after 24 months in the intervention group compared to the controls.
Read more
Secondary aims include: 1) Analyze cost-effectiveness; 2) Show a beneficial effect of the intervention on functional abilities, quality of life, and depressive and anxiety symptoms; 3) Investigate the impact of a lifestyle intervention on aging. In this sense, biological samples and neuroimaging studies will be collected to allow exploratory investigations on aging mechanisms, amyloid imbalance, tau pathology, epigenetics, neuroinflammation, vascular dysfunction, lipid dysregulation, white matter disintegration, cognitive and brain reserve.
This protocol is participant-centered, empowering citizens since the recruitment process to gain access to knowledge about their dementia risk status via web or by phone and then decide to participate. Intervention activities have also taken into account participants' perspective with the design of easy-to-use and appealing activities (e.g., using a self-administered at-home physical activity program such as VIVIFRAIL© and EXERCITA© cognitive training materials that have been developed, taking into account the Basque Country population's cultural, linguistic and educational particularities; and diet and nutritional workshops with famous chefs to learn innovative and attractive healthy recipes).
The GO-ON trial may shed light on the tools that people need to fulfill the expectation of an active, healthy dementia-free aging. These include digital tools that in the COVID19 pandemic have shown to be effective in removing distance barriers. GO-ON uses them to give support and expand the possibilities to clinical assessment settings and intervention delivery. The digital part of the intervention may expand preventive actions to small rural areas, including digital socialization.
GO-ON Study, which starts in summer 2021, is the first large-scale lifestyle intervention trial in Southern Europe that takes part in the WORLDWIDE FINGERs network and will help answer whether the FINGER results can be replicated. The intervention design has been made on the basis that if proven to be efficacious, it may be easily applied at a Public System-level to guarantee a rapid and easy translation of research results to Primary Care settings and people homes.
- Conditions
- Dementia, Cognitive Decline, Prevention, Life Style, Risk Factor, Cardiovascular, Diet Habit
- Being tested
- Multimodal intervention (MM-int)
- Medical subject headings
- Dementia, Cognitive Dysfunction, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal intervention (MM-int)Behavioural
- Cognitive intervention objective: To enhance cognitive functioning and incorporate daily habits and routines that are cognitively stimulating
- Socio-emotional intervention objective: • Promote socio-emotional skills associated with awareness, communication and regulation of emotions in late life.
- Nutritional intervention objective: To improve eating habits of participants to be based on the Mediterranean Dietary pattern by an educational program
- Physical activity intervention objective: To improve aerobic capacity y, decrease the risk of falls, and improve static and dynamic balance.
- Risk factors and comorbidities monitoring intervention: quarterly scheduled visits for a cardiovascular risk factors check-up and review active medication
| Study group | Role | What they receive |
|---|---|---|
| Standard health advice (SHA-control) | No intervention | The participant will receive verbal information of risk factors and information, reassessment, and written materials regarding approved recommendations on active and healthy aging on topics such as diet, physical activity, cognitive training as well as risk factor control following the state of the art and published guidelines by the Department of Health of the Basque Government/ Basque Country Public Health System (Osakidetza) and the WHO (Guidelines for risk reduction of cognitive decline and Dementia and the "Guidance on person-centered assessment and pathways in primary care - ICOPE"). Participants in this group will receive the best standard health care from their primary care and specialist health teams according to already established routines as well as usual social services assessments and care as needed. |
| Multidomain intervention (MM-Int) | Experimental | Participants in this group will receive the same verbal and written recommendations as to the ones in the SHA-Control group but then they will perform a 2 year structured program with periodic individual and group visits regarding 1) Risk factor control (vascular factors, polypharmacy); 2) Cognitive training, 3) Physical activity, 4) Dietary changing program and 5) emotional counseling and social engagement. Receives: Behavioral: Multimodal intervention (MM-int) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Cognitive performance
Cognitive performance will be assessed with the Neuropsychological Test Battery modified (NTBm) (Harrison J. et aet al.ch Neurol 2007).
The NTBm consists of 9 validated components: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 2 years
Secondary outcomes (6)
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.
- Change in specific cognitive domains will be assessed by the difference in pre-and postintervention scores in episodic memory, executive function and processing speed and visuospatial function z-scores.
Measured: up to 2 years
Incremental Cost-Utility Ratio (ICUR)
To estimate the cost-effectiveness of the intervention program the Incremental Cost-Utility Ratio (ICUR) between muntidomain intervention group and regular health advice group.
The incremental cost-utility ratio (ICUR) will be estimated by dividing incremental cost (Ca-Cb) by incremental utility (Ua-Ub). The time horizon was the patient's lifetime. A 3% discount rate will be applied to costs and effectiveness. Since the main economic impact of dementia is related to the care required as patients become dependent, a societal perspective will be used.
Measured: up to 2 years
Amsterdam questionnaire for Instrumental Activities of Daily Living (A-IADL-Q)
The Amsterdam IADL Questionnaire (A-IADL-Q) is an adaptive and computerized questionnaire designed to assess impairments in instrumental activities of daily living (IADL) in (early) dementia. The questionnaire is completed by a caregiver, such as a relative or friend. (Sikkes SA et al. 2012).
Measured: up to 2 years
Change in perceived Quality of life - EQ-D-5L scale
The EQ-5D-5L (Herdman M. et al. 2011) essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Measured: up to 2 years
Depressive and anxiety sympthoms. Hospital Anxiety and Depression Scale (HADS)
HADS was originally developed by Zigmond and Snaith (1983) and is commonly used to determine the levels of anxiety and depression that a person is experiencing. The HADS is a fourteen-item scale that generates: Seven of the items relate to anxiety and seven relate to depression.
Measured: up to 2 years
Change in cognitive performance in different groups of patients with the same APOE status
To assess whether differences between intervention groups concerning the primary and secondary cognitive outcomes vary among subgroups defined by APOE status as a genetic condition.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start3 Dec 2021
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies 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 Gipuzkoa GOIZ ZAINDU - GO-ON study is a two year randomized, controlled trial to evaluate the effectiveness of multi-component lifestyle and dementia risk factor intervention in preventing cognitive decline in older adults with cognitive frailty.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1,094 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion CITA-alzheimer
- Sponsor type
- University, hospital or other
- Collaborators
- Biogipuzkoa Health Research Institute, University of the Basque Country (UPV/EHU), Achucarro Basque Center For Neuroscience, NavarraBiomed Biomedical Research Center, Basque Culinary Center Fundazioa, Karolinska Institutet
- Responsible party
- Principal investigator, Mikel Tainta, Fundacion CITA-alzheimer
- Investigators
- Mikel Tainta, MD, Principal investigator, Principal InvestigatorPablo Martinez-Lage, MD PhD, Study chair, Scientific Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840030
- Sponsor's protocol ID
- Go-on_studyprotocol_v3_apr20
- Acronym
- CITA GO-ON
- Status last verified
- Feb 2023
- First submitted
- 26 Mar 2021
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to research raw data will be available after request. Following the foundational principles of data harmonization from the Worldwide FINGERs network, data might be shared after assuring participants' confidentiality and privacy, with WWFINGERs leaders from Karolinska Institute.
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 25771249
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Lifestyle Multidomain Intervention to Prevent Cognitive Decline in the Basque Country. GOIZ ZAINDU Gipuzkoa - CITA GO-ON Study
- ClinicalTrials.gov ID
- NCT04840030
- Acronym / sponsor ID
- CITA GO-ON / Go-on_studyprotocol_v3_apr20
- Conditions
- Dementia, Cognitive Decline, Prevention, Life Style, Risk Factor, Cardiovascular, Diet Habit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,094 participants (estimated)
- Lead sponsor
- Fundacion CITA-alzheimerUniversity, hospital or other
- Collaborators
- Biogipuzkoa Health Research Institute, University of the Basque Country (UPV/EHU), Achucarro Basque Center For Neuroscience, NavarraBiomed Biomedical Research Center, Basque Culinary Center Fundazioa, Karolinska Institutet
- Study start
- 3 Dec 2021 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 9 Apr 2021 (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.
The GOIZ ZAINDU Gipuzkoa - GO - ON Study is an intervention trial to evaluate the efficacy of dementia prevention strategies in cognitively frail people. It is a large-scale randomized controlled trial in over 1000 older adults between 60 and 85 years old with increased CAIDE risk score (≥6), non-demented but with low performance in at least one of three brief cognitive tests. Participants will be randomized to receive standard health advice (SHA-control) or a multidomain intervention (MM-Int) consisting of 1) Risk factor control (vascular factors, polypharmacy); 2) Cognitive training, 3) Physical activity, 4) Dietary changing program, and 5) emotional counseling and social engagement.
The primary aim is to demonstrate a 20% reduction in the proportion of subjects who decline in their NTB performance (z score) after 24 months in the intervention group compared to the controls.
Secondary aims include: 1) Analyze cost-effectiveness; 2) Show a beneficial effect of the intervention on functional abilities, quality of life, and depressive and anxiety symptoms; 3) Investigate the impact of a lifestyle intervention on aging. In this sense, biological samples and neuroimaging studies will be collected to allow exploratory investigations on aging mechanisms, amyloid imbalance, tau pathology, epigenetics, neuroinflammation, vascular dysfunction, lipid dysregulation, white matter disintegration, cognitive and brain reserve.
This protocol is participant-centered, empowering citizens since the recruitment process to gain access to knowledge about their dementia risk status via web or by phone and then decide to participate. Intervention activities have also taken into account participants' perspective with the design of easy-to-use and appealing activities (e.g., using a self-administered at-home physical activity program such as VIVIFRAIL© and EXERCITA© cognitive training materials that have been developed, taking into account the Basque Country population's cultural, linguistic and educational particularities; and diet and nutritional workshops with famous chefs to learn innovative and attractive healthy recipes).
The GO-ON trial may shed light on the tools that people need to fulfill the expectation of an active, healthy dementia-free aging. These include digital tools that in the COVID19 pandemic have shown to be effective in removing distance barriers. GO-ON uses them to give support and expand the possibilities to clinical assessment settings and intervention delivery. The digital part of the intervention may expand preventive actions to small rural areas, including digital socialization.
GO-ON Study, which starts in summer 2021, is the first large-scale lifestyle intervention trial in Southern Europe that takes part in the WORLDWIDE FINGERs network and will help answer whether the FINGER results can be replicated. The intervention design has been made on the basis that if proven to be efficacious, it may be easily applied at a Public System-level to guarantee a rapid and easy translation of research results to Primary Care settings and people homes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- The Gipuzkoa GOIZ ZAINDU - GO-ON study is a two year randomized, controlled trial to evaluate the effectiveness of multi-component lifestyle and dementia risk factor intervention in preventing cognitive decline in older adults with cognitive frailty.
| Arm | Type | Receives |
|---|---|---|
| Standard health advice (SHA-control) | No intervention | –The participant will receive verbal information of risk factors and information, reassessment, and written materials regarding approved recommendations on active and healthy aging on topics such as diet, physical activity, cognitive training as well as risk factor control following the state of the art and published guidelines by the Department of Health of the Basque Government/ Basque Country Public Health System (Osakidetza) and the WHO (Guidelines for risk reduction of cognitive decline and Dementia and the "Guidance on person-centered assessment and pathways in primary care - ICOPE"). Participants in this group will receive the best standard health care from their primary care and specialist health teams according to already established routines as well as usual social services assessments and care as needed. |
| Multidomain intervention (MM-Int) | Experimental | Behavioral: Multimodal intervention (MM-int)Participants in this group will receive the same verbal and written recommendations as to the ones in the SHA-Control group but then they will perform a 2 year structured program with periodic individual and group visits regarding 1) Risk factor control (vascular factors, polypharmacy); 2) Cognitive training, 3) Physical activity, 4) Dietary changing program and 5) emotional counseling and social engagement. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- People between 60-85 years old, willing to participate and comply with all the study evaluation and intervention procedures.
- With a CAIDE dementia Risk score ≥ 6
- Below-than-expected cognitive performance in at least one of three brief cognitive tests:
Key exclusion criteria (15 listed)
- Exclusion criteria are conditions that may affect the achievement of study objectives and procedures or clinical diagnoses that by themselves compromise participant's cognitive performance or compliance with study procedures. They include:
- Inability to perform a neuropsychological evaluation or a cognitive stimulation program (sensory limitation, mental retardation, illiteracy)
- Barthel index < 90.
- Geriatric Depression Scale ≥ 9
- Dementia or Moderate Cognitive impairment (MMSE < 20).
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 |
|---|---|---|
| Multimodal intervention (MM-int)1. Cognitive intervention objective: To enhance cognitive functioning and incorporate daily habits and routines that are cognitively stimulating 2. Socio-emotional intervention objective: • Promote socio-emotional skills associated with awareness, communication and regulation of emotions in late life. 3. Nutritional intervention objective: To improve eating habits of participants to be based on the Mediterranean Dietary pattern by an educational program 4. Physical activity intervention objective: To improve aerobic capacity y, decrease the risk of falls, and improve static and dynamic balance. 5. Risk factors and comorbidities monitoring intervention: quarterly scheduled visits for a cardiovascular risk factors check-up and review active medication | Behavioural | Multidomain intervention (MM-Int) |
Primary outcome
Global Cognitive performance
Time frame: up to 2 years
Cognitive performance will be assessed with the Neuropsychological Test Battery modified (NTBm) (Harrison J. et aet al.ch Neurol 2007). The NTBm consists of 9 validated components: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.
6 secondary outcomes
Performance in each cognitive domain
Time frame: up to 2 years
Incremental Cost-Utility Ratio (ICUR)
Time frame: up to 2 years
Amsterdam questionnaire for Instrumental Activities of Daily Living (A-IADL-Q)
Time frame: up to 2 years
Change in perceived Quality of life - EQ-D-5L scale
Time frame: up to 2 years
Depressive and anxiety sympthoms. Hospital Anxiety and Depression Scale (HADS)
Time frame: up to 2 years
Change in cognitive performance in different groups of patients with the same APOE status
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 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.
- Individual participant dataSharing planned: Yes. Access to research raw data will be available after request. Following the foundational principles of data harmonization from the Worldwide FINGERs network, data might be shared after assuring participants' confidentiality and privacy, with WWFINGERs leaders from Karolinska Institute.
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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
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 Multimodal intervention (MM-int) in people with Dementia and Cognitive Decline, 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 6 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 16 Feb 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?
Results are not available in the source record.
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?
Global Cognitive performance (time frame: up to 2 years). 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 NCT04840030, which also lists 1 linked publication.
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 16 Feb 2023.