Alzheimer DiseaseComfortage-P4NCT06896201
Comfortage - AD Prevention Strategies
A study testing Neuropsychological Assessments and Other Questionnaires, Blood Exams, Fluid Biomarkers, Genetics and Connectivity Analysis in people with Alzheimer Disease and Subjective Cognitive Impairment, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Study is Interventional, cross-sectional, clinical trial without drug and without device Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer Disease, Subjective Cognitive Impairment, Mild Cognitive Impairment
- What is being tested?
- Neuropsychological Assessments and Other Questionnaires, Blood Exams, Fluid Biomarkers, Genetics and Connectivity Analysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 7 Oct 2025to Mar 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjective cognitive decline, defined as self-experienced persistent decline in cognitive capacity in comparison with a previously normal status and unrelated to an acute event; normal performance on standardised cognitive tests adjusted for age, sex, and education; decline cannot be explained by psychiatric or other neurologic disease, medical disorder, medication, or substance use; no functional impact on daily life activities
- mild cognitive decline, defined as persistent decline in cognitive performance (in comparison with a previous status) reported by the subject or by an informed caregiver; or observed by change on longitudinal cognitive testing; cognitive performance below expected range for that individual based on cognitive test performance (adjusted for age, sex, and education); performs daily life activities independently (but cognitive difficulty may result in detectable but minimal functional impact on the more complex activities of daily life, either self-reported or corroborated by a study partner); Clinical Dementia Rating Scale = 0.5
- Ability to sign and understand the informed consent form
Who cannot join
- Age under 50 or over 85 years
- Non-native Italian speakers
- Non degenerative and secondary forms of dementia
- Previous or current participation in clinical trials with anti-amyloid agents
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
About this study
Official title: Comfortage - Integration of Biomarkers, Genetic and Clinical Risk Factors for AD Prevention Strategies
Study is Interventional, cross-sectional, clinical trial without drug and without device
- Being tested
- Neuropsychological Assessments and Other Questionnaires, Blood Exams, Fluid Biomarkers, Genetics, Connectivity Analysis, Physical Activity, Healthentia
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological Assessments and Other QuestionnairesDiagnostic test
A brief assessment of the cognitive status will be performed by the means of Mini-Mental State Examination (MMSE), Clinical Dementia Rating Scale (CDR-SB), Activities of the Daily Living (ADL) and Instrumental Activities of the Daily Living (IADL) scales. Moreover, extended neuropsychological assessments assessing memory, language, executive functions, attention and visuospatial perception will be conducted by trained neuropsychologists, as per clinical practice. Concerning depression and behavioural / neuropsychiatric symptoms, which are known to be relevant in cognitive decline and ageing, data will be collected by the means of Neuropsychiatric Inventory (NPI). Additional questionnaires about subjective cognitive decline, quality of sleep (Pittsburgh scale) and cognitive reserve (CRIq) will be conducted on some subgroups of subjects.
Blood Exams, Fluid Biomarkers, GeneticsBiological
All patients will undergo a blood samples collection at T0 and T4, as per clinical practice. Additional blood samples will be collected stored and processed according to literature recommendation-based standardized operating procedures.. Blood will be collected into EDTA tubes and will be immediately refrigerated and centrifugated at 2000x g for 10 minutes. Plasma will then be aliquoted in 0.5 ml polypropylene vials and frozen at -80°C. Levels of blood biomarkers of amyloidopathy, tauopathy, neurodegeneration and neuroinflammation will be measured using the Lumipulse G assays (Fujirebio) and the Multiplex assays for Ella (Biotechne). Whole blood samples will be used for genetic analysis, which will include the determination of APOE genotype
Connectivity AnalysisOther
Functional Magnetic Resonance Imaging (fMRI) and/or high-density electroencephalography (EEG) will be used to assess connectivity in selected group of subjects. EEG data will be collected during four 5-minute runs of alternating eyes-open and eyes-closed conditions using a 128-electrode high-density EEG system.
The EEG spectral coherence analysis will evaluate the functional coupling between the brain areas under study. Brain connectivity measures will be computed for each frequency band and for each subject, to be used as measure of weight of the graph in a graph analyses.
A subsample of subjects will be also investigated with connectivity measures of MRI by applying FA e DTI technique. All the data will be collected both at baseline and after a 2-years-period during which the prevention and intervention strategies will be performed.
Physical ActivityDevice
Participants will be proposed an unsupervised, monitored exercise program consisting of three 60-minute sessions of moderate-intensity aerobic exercise (40%-85% of their maximum heart rate) each week. To track exercise intensity. The activity will be personalized according to specific attitude of each subjects including walking session, bike sessions or swim sessions. The type, frequency and intensity of the activity will be recorded by means of a commercially available wearables (Garmin Vivosmart 4, Garmin Vivosmart 5) and the Healthentia application. Those non using the wearables will keep a diary of the activity. Study investigators will ensure both protocol adherence and participant safety through regular follow-up telephone contacts.
HealthentiaDevice
Healthentia, developed by Innovation Sprint, is a Software as a Medical Device (SaMD) designed for remote patient monitoring, virtual coaching, and automatic alerts using real-world data. It has been successfully used in over 20 studies and integrates features like teleconsultations, activity tracking, medication management, and support for wearable devices. It provides a patient companion app, offering remote patient monitoring and self-reporting, personalized advice or content in the form of dialogues. It is designed to optimize and improve patient engagement and ensure data integrity. The software facilitates daily self-reporting, providing information to patients and collecting other current data through self-reported questionnaires (health status, physical activity, quality of life, etc.), which will be crucial in order to control the adherence of patients to the program
EligenceDevice
Based Platform exercising the brain and the cognitive skills through 35+ games and activities designed by specialized health experts. It offers over 30 games focusing on cognitive skills such as memory, reasoning, attention, orientation, executive functions, construction skills, and language. It allows healthcare professionals to create personalized training sessions, monitor performance in real-time, and generate detailed evaluation reports. Accessible from any device, it is aimed at individuals in early stages of dementia or rehabilitation phases. In our clinical study, subjects will be trained on seven cognitive programs, which can be executed at home with or without assistance and supervision of a Health Professional (who can easily create personalized sessions to follow-up at distance) and/or an informal carer
NutritionOther
Participants will follow a personalized nutrition plan, as per clinical practice, receiving dietary advice derived by the same scheme already used in the FINGER project on prevention. The plan focuses on balanced, nutrient-rich meals, based on the reduction of carbohydrate assumption and stable inclusion of seeds, vegetables, fish and omega 3 aliments in the diet that may protect the brain through anti-inflammatory and antioxidant properties. A diary of the meals will be recorded in a diary included in the Healthentia application. No integrated meals or nutraceutical product will be used.
| Study group | Role | What they receive |
|---|---|---|
| SCD/MCI | Other | This 2 years study will include 100 individuals from two distinct clinical categories:
* subjects with subjective cognitive decline
* subjects with mild cognitive decline Receives: Diagnostic Test: Neuropsychological Assessments and Other Questionnaires; Biological: Blood Exams, Fluid Biomarkers, Genetics; Other: Connectivity Analysis; Device: Physical Activity; Device: Healthentia; Device: Eligence; Other: Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cognitive performance and quality of life through cognitive scales (MiniMental State Examination)
Statistically significant differences in changes in cognitive performance and quality of life after a 2-year intervention period, stratified by clinical, genetic, connectivity, and/or biomarker profiles through cognitive scales as MiniMental State Examination.
Measured: after 36 months
Changes in cognitive performance and quality of life through cognitive scales (Clinical Dementia Rating Scale)
Statistically significant differences in changes in cognitive performance and quality of life after a 2-year intervention period, stratified by clinical, genetic, connectivity, and/or biomarker profiles through cognitive scale as Clinical Dementia Rating Scale (CDR-SB).
Measured: after 36 months
Changes in cognitive performance and quality of life through cognitive scales (Activities of the Daily Living)
Statistically significant differences in changes in cognitive performance and quality of life after a 2-year intervention period, stratified by clinical, genetic, connectivity, and/or biomarker profiles through cognitive scale as Activities of the Daily Living (ADL).
Measured: after 36 months
Changes in cognitive performance and quality of life through cognitive scales (Instrumental activities of the daily living)
Statistically significant differences in changes in cognitive performance and quality of life after a 2-year intervention period, stratified by clinical, genetic, connectivity, and/or biomarker profiles through cognitive scale as Instrumental Activities of the Daily Living (IADL) scales.
Measured: after 36 months
Changes in cognitive performance and quality of life through questionnaires (Quality of sleep)
Statistically significant differences in changes in cognitive performance and quality of life after a 2-year intervention period, stratified by clinical, genetic, connectivity, and/or biomarker profiles through questionnaire as the quality of sleep (Pittsburgh scale).
Measured: after 36 months
Changes in cognitive performance and quality of life through questionnaires (Cognitive reserve)
Statistically significant differences in changes in cognitive performance and quality of life after a 2-year intervention period, stratified by clinical, genetic, connectivity, and/or biomarker profiles through questionnaires as the cognitive reserve (CRIq).
Measured: after 36 months
Secondary outcomes (7)
Measure of improvement in cognitive functioning
A greater than 20% improvement in cognitive functioning, as measured by standardized cognitive assessment tool as MiniMental State Examination, after a 2-year intervention period
Measured: after 36 months
Measure of improvement in cognitive functioning
A greater than 20% improvement in cognitive functioning, as measured by standardized cognitive assessment tool as MontReal Cognitive Assessment (MOCA), after a 2-year intervention period
Measured: after 36 months
Measure of improvement in quality of life
A greater than 35% improvement in quality of life, assessed through validated questionnaire as quality of sleep (Pittsburgh scale), following the 2-year intervention period
Measured: after 36 months
Measure of improvement in quality of life
A greater than 35% improvement in quality of life, assessed through validated questionnaire as cognitive reserve (CRIq), following the 2-year intervention period
Measured: after 36 months
inflammatory blood biomarker levels
Measurable and clinically relevant changes in AD neurodegenerative and inflammatory blood biomarker levels after the 2-year intervention period, correlating these changes with cognitive outcomes
Measured: after 36 months
Measure of improvement in user satisfaction
A greater than 45% improvement in user satisfaction and interaction with the novel tools and interventions, as measured by satisfaction questionnaire , after the 2-year intervention period
Measured: after 36 months
Measure of changes in brain connectivity
Measurable and clinically relevant changes in brain connectivity as resulted by electroencephalography (EEG) analyses after the 2-year intervention period, correlating these changes with cognitive outcomes.
Regarding EEG analysis, data will be acquired during four successive 5-min runs of alternating eyes-open and eyes-closed conditions using a high-density EEG (128 cephalic electrodes). Frequency bands of interest will be delta (2-4 Hz), theta (4-8 Hz), alpha1 (8-10.5 Hz), alpha2 (10.5-13 Hz), beta1 (13-20 Hz), beta2 (20-30 Hz) and gamma (30-40 Hz).
Measured: after 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start7 Oct 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional, cross-sectional, clinical trial without drug and without device
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896201
- Sponsor's protocol ID
- 7334
- Acronym
- Comfortage-P4
- Status last verified
- Sep 2026
- First submitted
- 26 Feb 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comfortage - Integration of Biomarkers, Genetic and Clinical Risk Factors for AD Prevention Strategies
- ClinicalTrials.gov ID
- NCT06896201
- Acronym / sponsor ID
- Comfortage-P4 / 7334
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 26 Mar 2025 (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.
Study is Interventional, cross-sectional, clinical trial without drug and without device
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional, cross-sectional, clinical trial without drug and without device
| Arm | Type | Receives |
|---|---|---|
| SCD/MCI | Other | Diagnostic Test: Neuropsychological Assessments and Other Questionnaires, Biological: Blood Exams, Fluid Biomarkers, Genetics, Other: Connectivity Analysis, Device: Physical Activity, Device: Healthentia, Device: Eligence, Other: NutritionThis 2 years study will include 100 individuals from two distinct clinical categories: * subjects with subjective cognitive decline * subjects with mild cognitive decline |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- subjective cognitive decline, defined as self-experienced persistent decline in cognitive capacity in comparison with a previously normal status and unrelated to an acute event; normal performance on standardised cognitive tests adjusted for age, sex, and education; decline cannot be explained by psychiatric or other neurologic disease, medical disorder, medication, or substance use; no functional impact on daily life activities
- mild cognitive decline, defined as persistent decline in cognitive performance (in comparison with a previous status) reported by the subject or by an informed caregiver; or observed by change on longitudinal cognitive testing; cognitive performance below expected range for that individual based on cognitive test performance (adjusted for age, sex, and education); performs daily life activities independently (but cognitive difficulty may result in detectable but minimal functional impact on the more complex activities of daily life, either self-reported or corroborated by a study partner); Clinical Dementia Rating Scale = 0.5
- Ability to sign and understand the informed consent form
Key exclusion criteria (4 listed)
- Age under 50 or over 85 years
- Non-native Italian speakers
- Non degenerative and secondary forms of dementia
- Previous or current participation in clinical trials with anti-amyloid agents
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 |
|---|---|---|
| Neuropsychological Assessments and Other QuestionnairesA brief assessment of the cognitive status will be performed by the means of Mini-Mental State Examination (MMSE), Clinical Dementia Rating Scale (CDR-SB), Activities of the Daily Living (ADL) and Instrumental Activities of the Daily Living (IADL) scales. Moreover, extended neuropsychological assessments assessing memory, language, executive functions, attention and visuospatial perception will be conducted by trained neuropsychologists, as per clinical practice. Concerning depression and behavioural / neuropsychiatric symptoms, which are known to be relevant in cognitive decline and ageing, data will be collected by the means of Neuropsychiatric Inventory (NPI). Additional questionnaires about subjective cognitive decline, quality of sleep (Pittsburgh scale) and cognitive reserve (CRIq) will be conducted on some subgroups of subjects. | Diagnostic test | SCD/MCI |
| Blood Exams, Fluid Biomarkers, GeneticsAll patients will undergo a blood samples collection at T0 and T4, as per clinical practice. Additional blood samples will be collected stored and processed according to literature recommendation-based standardized operating procedures.. Blood will be collected into EDTA tubes and will be immediately refrigerated and centrifugated at 2000x g for 10 minutes. Plasma will then be aliquoted in 0.5 ml polypropylene vials and frozen at -80°C. Levels of blood biomarkers of amyloidopathy, tauopathy, neurodegeneration and neuroinflammation will be measured using the Lumipulse G assays (Fujirebio) and the Multiplex assays for Ella (Biotechne). Whole blood samples will be used for genetic analysis, which will include the determination of APOE genotype | Biological | SCD/MCI |
| Connectivity AnalysisFunctional Magnetic Resonance Imaging (fMRI) and/or high-density electroencephalography (EEG) will be used to assess connectivity in selected group of subjects. EEG data will be collected during four 5-minute runs of alternating eyes-open and eyes-closed conditions using a 128-electrode high-density EEG system. The EEG spectral coherence analysis will evaluate the functional coupling between the brain areas under study. Brain connectivity measures will be computed for each frequency band and for each subject, to be used as measure of weight of the graph in a graph analyses. A subsample of subjects will be also investigated with connectivity measures of MRI by applying FA e DTI technique. All the data will be collected both at baseline and after a 2-years-period during which the prevention and intervention strategies will be performed. | Other | SCD/MCI |
| Physical ActivityParticipants will be proposed an unsupervised, monitored exercise program consisting of three 60-minute sessions of moderate-intensity aerobic exercise (40%-85% of their maximum heart rate) each week. To track exercise intensity. The activity will be personalized according to specific attitude of each subjects including walking session, bike sessions or swim sessions. The type, frequency and intensity of the activity will be recorded by means of a commercially available wearables (Garmin Vivosmart 4, Garmin Vivosmart 5) and the Healthentia application. Those non using the wearables will keep a diary of the activity. Study investigators will ensure both protocol adherence and participant safety through regular follow-up telephone contacts. | Device | SCD/MCI |
| HealthentiaHealthentia, developed by Innovation Sprint, is a Software as a Medical Device (SaMD) designed for remote patient monitoring, virtual coaching, and automatic alerts using real-world data. It has been successfully used in over 20 studies and integrates features like teleconsultations, activity tracking, medication management, and support for wearable devices. It provides a patient companion app, offering remote patient monitoring and self-reporting, personalized advice or content in the form of dialogues. It is designed to optimize and improve patient engagement and ensure data integrity. The software facilitates daily self-reporting, providing information to patients and collecting other current data through self-reported questionnaires (health status, physical activity, quality of life, etc.), which will be crucial in order to control the adherence of patients to the program | Device | SCD/MCI |
| EligenceBased Platform exercising the brain and the cognitive skills through 35+ games and activities designed by specialized health experts. It offers over 30 games focusing on cognitive skills such as memory, reasoning, attention, orientation, executive functions, construction skills, and language. It allows healthcare professionals to create personalized training sessions, monitor performance in real-time, and generate detailed evaluation reports. Accessible from any device, it is aimed at individuals in early stages of dementia or rehabilitation phases. In our clinical study, subjects will be trained on seven cognitive programs, which can be executed at home with or without assistance and supervision of a Health Professional (who can easily create personalized sessions to follow-up at distance) and/or an informal carer | Device | SCD/MCI |
| NutritionParticipants will follow a personalized nutrition plan, as per clinical practice, receiving dietary advice derived by the same scheme already used in the FINGER project on prevention. The plan focuses on balanced, nutrient-rich meals, based on the reduction of carbohydrate assumption and stable inclusion of seeds, vegetables, fish and omega 3 aliments in the diet that may protect the brain through anti-inflammatory and antioxidant properties. A diary of the meals will be recorded in a diary included in the Healthentia application. No integrated meals or nutraceutical product will be used. | Other | SCD/MCI |
Primary outcome
Changes in cognitive performance and quality of life through cognitive scales (MiniMental State Examination)
Time frame: after 36 months
Statistically significant differences in changes in cognitive performance and quality of life after a 2-year intervention period, stratified by clinical, genetic, connectivity, and/or biomarker profiles through cognitive scales as MiniMental State Examination.
Changes in cognitive performance and quality of life through cognitive scales (Clinical Dementia Rating Scale)
Time frame: after 36 months
Statistically significant differences in changes in cognitive performance and quality of life after a 2-year intervention period, stratified by clinical, genetic, connectivity, and/or biomarker profiles through cognitive scale as Clinical Dementia Rating Scale (CDR-SB).
Changes in cognitive performance and quality of life through cognitive scales (Activities of the Daily Living)
Time frame: after 36 months
Statistically significant differences in changes in cognitive performance and quality of life after a 2-year intervention period, stratified by clinical, genetic, connectivity, and/or biomarker profiles through cognitive scale as Activities of the Daily Living (ADL).
Changes in cognitive performance and quality of life through cognitive scales (Instrumental activities of the daily living)
Time frame: after 36 months
Statistically significant differences in changes in cognitive performance and quality of life after a 2-year intervention period, stratified by clinical, genetic, connectivity, and/or biomarker profiles through cognitive scale as Instrumental Activities of the Daily Living (IADL) scales.
Changes in cognitive performance and quality of life through questionnaires (Quality of sleep)
Time frame: after 36 months
Statistically significant differences in changes in cognitive performance and quality of life after a 2-year intervention period, stratified by clinical, genetic, connectivity, and/or biomarker profiles through questionnaire as the quality of sleep (Pittsburgh scale).
Changes in cognitive performance and quality of life through questionnaires (Cognitive reserve)
Time frame: after 36 months
Statistically significant differences in changes in cognitive performance and quality of life after a 2-year intervention period, stratified by clinical, genetic, connectivity, and/or biomarker profiles through questionnaires as the cognitive reserve (CRIq).
7 secondary outcomes
Measure of improvement in cognitive functioning
Time frame: after 36 months
Measure of improvement in cognitive functioning
Time frame: after 36 months
Measure of improvement in quality of life
Time frame: after 36 months
Measure of improvement in quality of life
Time frame: after 36 months
inflammatory blood biomarker levels
Time frame: after 36 months
Measure of improvement in user satisfaction
Time frame: after 36 months
Measure of changes in brain connectivity
Time frame: after 36 months
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 3 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological Assessments and Other Questionnaires, Blood Exams, Fluid Biomarkers, Genetics and Connectivity Analysis in people with Alzheimer Disease and Subjective Cognitive Impairment, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 3 inclusion and 4 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 3 Sep 2026. 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 Italy. 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?
Changes in cognitive performance and quality of life through cognitive scales (MiniMental State Examination) (time frame: after 36 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2026.