Cognitive DeclineFINGER-NLNCT05256199
Dutch Multidomain Lifestyle Intervention in Older Adults at Risk of Cognitive Decline
A study testing Multidomain lifestyle intervention in people with Cognitive Decline and Life Style, run by Alzheimercentrum Amsterdam at 5 sites in Netherlands.
Trial summary
FINGER-NL is a multi-center, randomized, controlled, multidomain lifestyle intervention trial among 1,206 older adults at risk for cognitive decline with a duration of 24 months. Read more about this study
- Who is it for?
- Ages 60 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline, Life Style, Risk Reduction
- What is being tested?
- Multidomain lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,210 participants
- Where
- 5 sitesNetherlands
- Study dates
- 24 Feb 2022to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60-79 years of age at pre-screening;
- Adequate fluency in Dutch to understand the informed consent and complete questionnaires;
- Providing informed consent to all study procedures;
- Internet access at home;
- Presence of ≥3 self-reported risk factors for cognitive decline (must contain at least 2 modifiable risk factors and 1 non-modifiable riskfactor).
Who cannot join
- Diagnosis of dementia or mild cognitive impairment at baseline (self-reported);
- Significant cognitive impairment assessed using the Modified Telephone Interview for Cognitive Status battery (TICSm score<23);
- Conditions affecting safe and continuous engagement in the intervention (e.g. under treatment for current malignant diseases, major psychiatric disorders (e.g. major depression, psychosis, bipolar disorder), neurological disorders (e.g. Parkinson's disease, multiple sclerosis), symptomatic cardiovascular disease (e.g. stroke, angina pectoris, heart failure, myocardial infarction), re-vascularization within three months, severe loss of vision, hearing or communicative ability, severe mobility impairment, other conditions preventing co-operation) as judged by the local study nurse or consulted physician at the local study site;
- Coincident participation in any other intervention trial at time of pre-screening.
- Coincident participation of spouse in FINGER-NL trial.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Netherlands5 sites
Alzheimer Center Amsterdam
Amsterdam, 1671 EA
University Medical Center Groningen
Groningen
Maastricht University
Maastricht
Radboud University
Nijmegen
Wageningen Unversity and Research
Wageningen
About this study
FINGER-NL is a multi-center, randomized, controlled, multidomain lifestyle intervention trial among 1,206 older adults at risk for cognitive decline with a duration of 24 months. Participants are randomized in a 1:1 ratio to a personalized multi-domain lifestyle intervention (high-intensity intervention group) versus online access to general lifestyle-related health information (low-intensity intervention group). After the intervention period, participants are invited for a 24 month extension of follow-up.
- Conditions
- Cognitive Decline, Life Style, Risk Reduction
- Being tested
- Multidomain lifestyle intervention
- Medical subject headings
- Cognitive Dysfunction, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidomain lifestyle interventionBehavioural
A multidomain lifestyle intervention, including (1) physical activity, (2) cognitive training, (3) cardiovascular risk factor management (Cardiovascular), (4) dietary counselling, (5) Souvenaid, (6) sleep counselling, (7) stress management, and (8) social activities.
| Study group | Role | What they receive |
|---|---|---|
| high-intensity group | Experimental | The high intensity group receives a personalized, supervised intervention consisting of group meetings and individual sessions. Receives: Behavioral: Multidomain lifestyle intervention |
| low-intensity group | No intervention | The low-intensity arm receives online access to general lifestyle-related health information. |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year change from baseline in global cognitive composite score
Global cognitive composite score derived from subtest scores from the Neuropsychological Test Battery (NTB) that includes 15-Word Verbal Learning Test delayed recall (discrete number; 0-15 (higher score means a better outcome)), Digit Symbol Substitution Test 90 seconds (discrete number; 0-90 (higher score means a better outcome)), WAIS digit span backwards (discrete number; 0-14 (higher score means a better outcome)), and semantic fluency (discrete number; 0-no maximum, higher score means a better outcome)).
Measured: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Secondary outcomes (36)
15-Word Verbal Learning Test delayed recall
discrete number; score: 0-15 (higher score means a better outcome)
Measured: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Digit Symbol Substitution Test 90 seconds
discrete number; 0-90 (higher score means a better outcome)
Measured: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Wechsler Adult Intelligence Scale (WAIS) digit span backwards
discrete number; 0-14 (higher score means a better outcome)
Measured: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Semantic fluency
word count in one minute; minimum 0, no maximum, higher score means a better outcome.
Measured: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Instrumental activities of daily living using the Amsterdam Instrumental Activity of Daily Living Questionnaire (A-IADL-Q)
Total scores range approximately 20-70, higher scores indicate better IADL functioning
Measured: 2 years (measured at baseline, follow-up 1 and follow-up 2)
5 level EuroQol-5D (EQ-5D-5L)
Quality of life, score 0-100, higher scores indicate better quality of life
Measured: 2 years (measured at baseline, follow-up 1 and follow-up 2)
LIfestyle for BRAin health (LIBRA)
Modifiable dementia risk using lifestyle for brain health; The score ranges from -5.9 (minimum score) to +12.7 (maximum score), with higher scores meaning a worse outcome (higher dementia risk)
Measured: 2 years (measured at baseline, follow-up 1 and follow-up 2)
grip strength test
Scores between 0 to 90 kg can be measured on the Jamar Hand dynamometer, with higher scores indicating better grip strength
Measured: 2 years (measured at baseline, follow-up 1 and follow-up 2)
SQUASH questionnaire
METs derived from the Ainsworth's compendium of physical activity will be used to classify physical activity intensity (<1.5METs- sedentary, 1.6-2.9 METs- light, 3.0-5.9METs- moderate, >6.0- vigorous physical activity).
Measured: 2 years (measured at baseline, follow-up 1 and follow-up 2)
LASA Sedentary Behavior Questionnaire
Average hours and minutes of sedentary behavior a day, range from 0 to 24 hours. Higher scores (more hours) means a more sedentary behavior.
Measured: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Pittsburgh Fatigability Scale
Total physical and mental fatigability scores range from 0-50, with higher scores indicating higher fatigability.
Measured: 2 years (measured at baseline, follow-up 1 and follow-up 2)
SARC-F Sarcopenia Questionnaire
sarcopenia, scores range from 0 to 10 (i.e. 0-2 points for each component; 0 = best to 10 = worst).
Measured: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF)
Total scale ranges from 24 - 120, higher scores indicate more mindfulness
Measured: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Perceived Stress Scale
Total score, scale 0 - 40, higher scores indicate more perceived stress
Measured: 2 years (measured at baseline, follow-up 1 and follow-up 2)
MetaMemory in Adulthood (MIA)
Sum of Part 1 + Part 2A and B. Part 1: Strategy (scores 10 - 50, higher scores indicate more use of strategies), Part 2A: Subjective memory functioning, scores ranges from 23 - 115, with higher scores indicate better memory self-efficacy and 2B: Locus, scores ranges from 7 - 35, higher scores indicate better perceived personal control over remembering abilities.
Measured: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Blood pressure
scores range from approximately (for diastolic) 60-120 and (for systolic) 100-180 mmHg, with higher scores indicating higher blood pressure.
Measured: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Cholesterol
total (healthy level: 125 to 200mg/dL), HDL (healthy level = 40mg/dL or higher), LDL (healthy level = Less than 100mg/dL) + triglycerides (healthy level = less than 150-199 mg/dL)
Measured: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Blood glucose
HbA1C, scores range from approximately 30-100 mmol/mol, with higher scores indicate higher blood glucose levels.
Measured: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Waist circumference
measured in cm
Measured: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Hip circumference
measured in cm
Measured: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Height
measured in cm
Measured: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Weight
measured in kg
Measured: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Hill-Bone Medication Adherence Scale
scores range from 9-26, with lower scores indicating better medication adherence
Measured: 2 years (measured at baseline, follow-up 1 and follow-up 2)
MIND-adjusted Eetscore-FFQ
Dutch Healthy Diet Index 2015 score (range 0-160 points, higher scores mean better outcome) and MIND score (range 0-15 points, higher scores mean better outcome), assessed by a short Food Frequency Questionnaire.
Measured: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Nutritional intake
Change in nutritional intake measured by an online 3-day food diary (assessed by Traqq application), qualitative assessment
Measured: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Pittsburg Sleep Quality Index
Total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality
Measured: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Insomnia severity index
The score ranges from 0 (minimum score) to 28 (maximum score), with lower scores indicating a better outcome
Measured: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Lubben Social Network Scale
The score ranges from 0 (minimum score) to 30 (maximum score), with higher scores meaning a better outcome (higher level of perceived social support)
Measured: 2 years (measured at baseline, follow-up 1 and follow-up 2)
De Jong Gierveldt Loneliness Scale
The score ranges from 0 (minimum score) to 6 (maximum score), with higher scores representing a worse outcome (higher loneliness scores)
Measured: 2 years (measured at baseline and follow-up 2)
Aβ42/40 ratio
amyloid-β (1-42)/(1-40) (pg/mL)
Measured: 2 years (measured at baseline and follow-up 2)
p-tau
phosphorylated tau (pg/mL)
Measured: 2 years (measured at baseline and follow-up 2)
NfL
neurofilament light chain (pg/mL)
Measured: 2 years (measured at baseline and follow-up 2)
GFAP
glial fibrillary acidic protein (pg/mL)
Measured: 2 years (measured at baseline and follow-up 2)
BDNF
brain-derived neurotrophic factor (pg/mL)
Measured: 2 years (measured at baseline and follow-up 2)
Actigraph (Groningen site only)
physical activity, sedentary behavior and sleep-wake activity
Measured: 2 year (measured for 1 week at baseline, follow-up 1 and follow-up 2)
Physical Activity Record questionnaire (Groningen site only)
physical activity, sedentary behavior and sleep-wake activity
Measured: 2 year (measured for 1 week at baseline, follow-up 1 and follow-up 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start24 Feb 2022
- Primary completion30 Jul 2025
- Study completion1 Aug 2027 (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 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alzheimercentrum Amsterdam
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University, Radboud University Medical Center, Wageningen University and Research, University Medical Center Groningen, Danone Nutricia Research
- Responsible party
- Principal investigator, Marissa Zwan, Amsterdam UMC, location VUmc
- Investigators
- Marissa D. Zwan, Dr., Principal investigator, Alzheimer Center AmsterdamSebastian Köhler, Prof., Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256199
- Sponsor's protocol ID
- 2021.0220
- Other IDs
- NL77242.029.21
- Acronym
- FINGER-NL
- Status last verified
- May 2026
- First submitted
- 11 Jan 2022
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Deckers K, Zwan MD, Soons LM, Waterink L, Beers S, van Houdt S, Stiensma B, Kwant JZ, Wimmers SCPM, Heutz RAM, Claassen JAHR, Oosterman JM, de Heus RAA, van de Rest O, Vermeiren Y, Voshaar RCO, Smidt N, Broersen LM, Sikkes SAM, Aarts E; MOCIA consortium; FINGER-NL consortium; Kohler S, van der Flier WM. A multidomain lifestyle intervention to maintain optimal cognitive functioning in Dutch older adults-study design and baseline characteristics of the FINGER-NL randomized controlled trial. Alzheimers Res Ther. 2024 Jun 13;16(1):126. doi: 10.1186/s13195-024-01495-8.
PubMed 38872204
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dutch Multidomain Lifestyle Intervention in Older Adults at Risk of Cognitive Decline
- ClinicalTrials.gov ID
- NCT05256199
- Acronym / sponsor ID
- FINGER-NL / 2021.0220
- Conditions
- Cognitive Decline, Life Style, Risk Reduction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,210 participants (actual)
- Lead sponsor
- Alzheimercentrum AmsterdamUniversity, hospital or other
- Collaborators
- Maastricht University, Radboud University Medical Center, Wageningen University and Research, University Medical Center Groningen, Danone Nutricia Research
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 25 Feb 2022 (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.
FINGER-NL is a multi-center, randomized, controlled, multidomain lifestyle intervention trial among 1,206 older adults at risk for cognitive decline with a duration of 24 months. Participants are randomized in a 1:1 ratio to a personalized multi-domain lifestyle intervention (high-intensity intervention group) versus online access to general lifestyle-related health information (low-intensity intervention group). After the intervention period, participants are invited for a 24 month extension of follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high-intensity group | Experimental | Behavioral: Multidomain lifestyle interventionThe high intensity group receives a personalized, supervised intervention consisting of group meetings and individual sessions. |
| low-intensity group | No intervention | –The low-intensity arm receives online access to general lifestyle-related health information. |
Who may qualify
- Ages
- 60 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 60-79 years of age at pre-screening;
- Adequate fluency in Dutch to understand the informed consent and complete questionnaires;
- Providing informed consent to all study procedures;
- Internet access at home;
- Presence of ≥3 self-reported risk factors for cognitive decline (must contain at least 2 modifiable risk factors and 1 non-modifiable riskfactor).
Key exclusion criteria (5 listed)
- Diagnosis of dementia or mild cognitive impairment at baseline (self-reported);
- Significant cognitive impairment assessed using the Modified Telephone Interview for Cognitive Status battery (TICSm score<23);
- Conditions affecting safe and continuous engagement in the intervention (e.g. under treatment for current malignant diseases, major psychiatric disorders (e.g. major depression, psychosis, bipolar disorder), neurological disorders (e.g. Parkinson's disease, multiple sclerosis), symptomatic cardiovascular disease (e.g. stroke, angina pectoris, heart failure, myocardial infarction), re-vascularization within three months, severe loss of vision, hearing or communicative ability, severe mobility impairment, other conditions preventing co-operation) as judged by the local study nurse or consulted physician at the local study site;
- Coincident participation in any other intervention trial at time of pre-screening.
- Coincident participation of spouse in FINGER-NL trial.
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 lifestyle interventionA multidomain lifestyle intervention, including (1) physical activity, (2) cognitive training, (3) cardiovascular risk factor management (Cardiovascular), (4) dietary counselling, (5) Souvenaid, (6) sleep counselling, (7) stress management, and (8) social activities. | Behavioural | high-intensity group |
Primary outcome
2-year change from baseline in global cognitive composite score
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Global cognitive composite score derived from subtest scores from the Neuropsychological Test Battery (NTB) that includes 15-Word Verbal Learning Test delayed recall (discrete number; 0-15 (higher score means a better outcome)), Digit Symbol Substitution Test 90 seconds (discrete number; 0-90 (higher score means a better outcome)), WAIS digit span backwards (discrete number; 0-14 (higher score means a better outcome)), and semantic fluency (discrete number; 0-no maximum, higher score means a better outcome)).
36 secondary outcomes
15-Word Verbal Learning Test delayed recall
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Digit Symbol Substitution Test 90 seconds
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Wechsler Adult Intelligence Scale (WAIS) digit span backwards
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Semantic fluency
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Instrumental activities of daily living using the Amsterdam Instrumental Activity of Daily Living Questionnaire (A-IADL-Q)
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
5 level EuroQol-5D (EQ-5D-5L)
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
LIfestyle for BRAin health (LIBRA)
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
grip strength test
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
SQUASH questionnaire
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
LASA Sedentary Behavior Questionnaire
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Pittsburgh Fatigability Scale
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
SARC-F Sarcopenia Questionnaire
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF)
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Perceived Stress Scale
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
MetaMemory in Adulthood (MIA)
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Blood pressure
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Cholesterol
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Blood glucose
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Waist circumference
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Hip circumference
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Height
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Weight
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Hill-Bone Medication Adherence Scale
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
MIND-adjusted Eetscore-FFQ
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Nutritional intake
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Pittsburg Sleep Quality Index
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Insomnia severity index
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Lubben Social Network Scale
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
De Jong Gierveldt Loneliness Scale
Time frame: 2 years (measured at baseline and follow-up 2)
Aβ42/40 ratio
Time frame: 2 years (measured at baseline and follow-up 2)
p-tau
Time frame: 2 years (measured at baseline and follow-up 2)
NfL
Time frame: 2 years (measured at baseline and follow-up 2)
GFAP
Time frame: 2 years (measured at baseline and follow-up 2)
BDNF
Time frame: 2 years (measured at baseline and follow-up 2)
Actigraph (Groningen site only)
Time frame: 2 year (measured for 1 week at baseline, follow-up 1 and follow-up 2)
Physical Activity Record questionnaire (Groningen site only)
Time frame: 2 year (measured for 1 week at baseline, follow-up 1 and follow-up 2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Derived from this study: PubMed 38872204Deckers K, Zwan MD, Soons LM, Waterink L, Beers S, van Houdt S, Stiensma B, Kwant JZ, Wimmers SCPM, Heutz RAM, Claassen JAHR, Oosterman JM, de Heus RAA, van de Rest O, Vermeiren Y, Voshaar RCO, Smidt N, Broersen LM, Sikkes SAM, Aarts E; MOCIA consortium; FINGER-NL consortium; Kohler S, van der Flier WM. A multidomain lifestyle intervention to maintain optimal cognitive functioning in Dutch older adults-study design and baseline characteristics of the FINGER-NL randomized controlled trial. Alzheimers Res Ther. 2024 Jun 13;16(1):126. doi: 10.1186/s13195-024-01495-8.
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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.
Marissa D. Zwan, Dr. principal investigator
Alzheimer Center Amsterdam
Sebastian Köhler, Prof. principal investigator
Maastricht University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidomain lifestyle intervention in people with Cognitive Decline and Life Style, run by Alzheimercentrum Amsterdam at 5 sites in Netherlands.
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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
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?
2-year change from baseline in global cognitive composite score (time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)). 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 NCT05256199, 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 2 Jun 2026.