Alzheimer DiseaseCOMFORTageNCT07031167
The COMFORTage Project at Ace Alzheimer Center Barcelona
A study testing Cognitive and functional stimulation using digital platforms in people with Alzheimer Disease and Mild Cognitive Impairment, run by Fundació ACE Institut Català de Neurociències Aplicades at 1 site in Spain.
Trial summary
The COMFORTage study at Ace Alzheimer Center Barcelona is investigating whether a personalized cognitive and functional stimulation program can help slow cognitive decline in individuals diagnosed with mild cognitive impairment (MCI) or mild Alzheimer's disease (AD) dementia. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment
- What is being tested?
- Cognitive and functional stimulation using digital platforms
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2025to 1 Jul 2028
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 60 and 85 years.
- Diagnosis of MCI based on Petersen criteria with a CDR score of 0.5.
- Diagnosis of mild AD dementia according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria with a CDR score of 1.
- Proficiency in using digital tools such as mobile apps, tablets, or computers.
- Ability and willingness to attend regular in-person sessions at Ace Alzheimer Center Barcelona.
- Provided written informed consent after receiving a full explanation of the study.
Who cannot join
- History of traumatic brain injury.
- Diagnosis of severe depression.
- History of stroke or brain tumors.
- Presence of significant uncorrected visual or auditory impairments.
- Lack of access to a digital device or internet connection.
- Inability to participate in regular in-person sessions at the study site.
- Any medical condition that may confound cognitive assessment or limit participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Ace Alzheimer Centre Barcelona (Fundació ACE)
Barcelona, Barcelona, 08028
Sergi Valero, 934447318, svalero@fundacioace.org
About this study
Official title: The COMFORTage Project: Integration of Multiple Sources Towards Personalized Preventions at Ace Alzheimer Center Barcelona
The COMFORTage study at Ace Alzheimer Center Barcelona is investigating whether a personalized cognitive and functional stimulation program can help slow cognitive decline in individuals diagnosed with mild cognitive impairment (MCI) or mild Alzheimer's disease (AD) dementia.
The study involves 100 participants aged 60 to 85, who are randomly assigned to one of two groups. The active group receives weekly in-person sessions for one year, featuring individualized cognitive and physical training through digital platforms developed by the COMFORTage project. The control group does not participate in the training but undergoes the same schedule of health assessments and monitoring.
Read more
All participants are followed for a total of two years. Throughout the study, researchers collect comprehensive clinical, neuropsychological, and biological data. This includes cognitive assessments, magnetic resonance imaging (MRI) brain scans, blood and cerebrospinal fluid (CSF) samples, and genetic testing. In addition, participants complete spontaneous speech recordings from home every 3-4 months using a dedicated mobile application.
The primary objective is to determine whether the stimulation program more effectively preserves memory and cognitive function compared to no intervention. The study also evaluates its impact on physical and emotional well-being, daily functioning, and quality of life. Insights from the trial will contribute to the development of an artificial intelligence (AI)-powered digital health platform aimed at delivering personalized care for individuals living with dementia.
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment
- Being tested
- Cognitive and functional stimulation using digital platforms
- 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.
Cognitive and functional stimulation using digital platformsBehavioural
Participants in the intervention group receive personalized cognitive and functional stimulation over one year through digital platforms developed by the COMFORTage project. These include Eligence, a brain-training tool featuring interactive games targeting memory, attention, and language; Language Games, which assess and train linguistic and cognitive skills in realistic scenarios; and Healthentia, a platform that monitors daily health metrics and provides virtual coaching. Sessions are conducted both in person and remotely, and are adapted to each participant's abilities and level of digital literacy. The intervention aims to support cognitive health and daily functioning in individuals with MCI or mild AD.
| Study group | Role | What they receive |
|---|---|---|
| Non-Active Functional Intervention | No intervention | No stimulation activity |
| Active Functional Intervention | Experimental | Stimulation activity Receives: Behavioral: Cognitive and functional stimulation using digital platforms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in neuropsychological assessment
Assesses the change in cognitive function over two years using composite scores from the Neuropsychological Battery used at Ace (NBACE). The scores evaluate five domains: attention, memory, visuospatial/visuoperceptual functions, executive functions, and language. The scores for each domain range from -3 (low competence) to 3 (high competence).
Measured: Baseline, 1-year follow-up, and 2-year follow-up
Secondary outcomes (17)
Change in Mini-Mental State Examination (MMSE) score
This test is administered to assess general cognitive function. Results are expressed as points on a scale from 0 (severe cognitive impairment) to 30 (normal cognitive function).
Measured: Baseline, 1-year follow-up, and 2-year follow-up
Change in Memory Test Score from the 7-Minute Screen Test (Spanish version)
This test measures memory recall for cognitive screening purposes. The unit of measure is points on a scale from 0 (poor recall) to 7 (excellent recall).
Measured: Baseline, 1-year follow-up, and 2-year follow-up
Change in Hachinski Ischemia Scale score
This scale evaluates the vascular contribution to cognitive impairment. Scores range from 0 (pure Alzheimer's disease) to 18 (multi-infarct dementia likely).
Measured: Baseline, 1-year follow-up, and 2-year follow-up
Change in Neuropsychiatric Inventory Questionnaire (NPI-Q) score
NPI-Q assesses behavioral and psychological symptoms in dementia, using a scale from 0 to 36 where higher scores indicate greater symptom severity and caregiver distress.
Measured: Baseline, 1-year follow-up, and 2-year follow-up
Change in Global Deterioration Scale (GDS) score
GDS assesses stages of cognitive decline from normal aging to severe dementia. Scores range from 1 (no cognitive decline) to 7 (very severe cognitive decline).
Measured: Baseline, 1-year follow-up, and 2-year follow-up
Change in Clinical Dementia Rating (CDR) score
CDR evaluates the severity of dementia symptoms across multiple domains, using a global score from 0 (no dementia) to 3 (severe dementia).
Measured: Baseline, 1-year follow-up, and 2-year follow-up
Change in Blessed Dementia Scale score
This test measures functional deterioration related to dementia. Scores range from 0 (normal function) to 28 (severe dementia-related impairment).
Measured: Baseline, 1-year follow-up, and 2-year follow-up
Change in Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) score
CAIDE evaluates long-term dementia risk associated with cardiovascular and lifestyle-related factors. The score is a composite with no fixed scale; a higher score indicates a higher risk.
Measured: Baseline, 1-year follow-up, and 2-year follow-up
Change in Cumulative Illness Rating Scale (CRIS) score
CRIS assesses comorbidity burden across organ systems to quantify illness severity. The score per domain ranges from 0 (no impairment) to 4 (extremely severe), and a summed score is used.
Measured: Baseline, 1-year follow-up, and 2-year follow-up
Change in body weight
Participants' weight is measured to monitor physical health and its association with cognitive and functional outcomes, recorded in kilograms (kg).
Measured: Baseline, 1-year follow-up, and 2-year follow-up
Change in body height
This supports anthropometric analysis by recording participants' height in centimeters (cm).
Measured: Baseline, 1-year follow-up, and 2-year follow-up
Change in abdominal circumference
Measured in cm, this indicates central adiposity and metabolic risk.
Measured: Baseline, 1-year follow-up, and 2-year follow-up
Change in blood pressure
Systolic and diastolic pressures are measured as indicators of cardiovascular health, expressed in millimeters of mercury (mmHg).
Measured: Baseline, 1-year follow-up, and 2-year follow-up
Questionnaire for User Interaction Satisfaction (QUIS)
QUIS evaluates satisfaction with digital tool usability and interaction. Each question is rated from 1 (very poor satisfaction) to 9 (very high satisfaction).
Measured: Baseline, 1-year follow-up, and 2-year follow-up
5-level EQ-5D (EQ5D5L) questionnaire
EQ5D5L measures health-related quality of life across five dimensions. Responses are recorded as five-level categorical options per domain and on a scale from 0 (worst health) to 100 (best imaginable health).
Measured: Baseline, 1-year follow-up, and 2-year follow-up
Change in concentration of plasma biomarkers
Plasma samples are analyzed for phosphorylated tau isoforms (pTau181 and pTau217) to evaluate longitudinal changes related to cognitive decline. Results are reported in picograms per milliliter (pg/mL).
Measured: Baseline, 1-year follow-up, and 2-year follow-up
Basal evaluation of CSF biomarkers
CSF samples are analyzed at the beginning of the study for AD biomarkers (amyloid beta 40 (Aβ40) and amyloid beta 42 (Aβ42), phosphorylated tau, total tau), following Alzheimer's Biomarker Standardization Initiative protocols. Units are pg/mL.
Measured: Once at the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (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 Alzheimer DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació ACE Institut Català de Neurociències Aplicades
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031167
- Sponsor's protocol ID
- comfortage_ace_1
- Acronym
- COMFORTage
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Valero S, Miguel A, Blazquez-Folch J, Calm B, Alegret M, Solivar A, Manias G, Antoniades A, Angelova N, Psimaris D, Segkouli S, Morera A, Tantinya N, Rosende-Roca M, Cano A, Fernandez MV, Sanz-Cartagena P, Gurruchaga MJ, Tarraga L, Boada M, Ruiz A, Marquie M; and COMFORTage Consortium. The COMFORTage project: study protocol for the integration of multiple sources towards personalised preventions at Ace Alzheimer Center Barcelona. Front Digit Health. 2026 Jan 26;7:1633507. doi: 10.3389/fdgth.2025.1633507. eCollection 2025.
PubMed 41669721
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The COMFORTage Project: Integration of Multiple Sources Towards Personalized Preventions at Ace Alzheimer Center Barcelona
- ClinicalTrials.gov ID
- NCT07031167
- Acronym / sponsor ID
- COMFORTage / comfortage_ace_1
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fundació ACE Institut Català de Neurociències AplicadesUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 22 Jun 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.
The COMFORTage study at Ace Alzheimer Center Barcelona is investigating whether a personalized cognitive and functional stimulation program can help slow cognitive decline in individuals diagnosed with mild cognitive impairment (MCI) or mild Alzheimer's disease (AD) dementia.
The study involves 100 participants aged 60 to 85, who are randomly assigned to one of two groups. The active group receives weekly in-person sessions for one year, featuring individualized cognitive and physical training through digital platforms developed by the COMFORTage project. The control group does not participate in the training but undergoes the same schedule of health assessments and monitoring.
All participants are followed for a total of two years. Throughout the study, researchers collect comprehensive clinical, neuropsychological, and biological data. This includes cognitive assessments, magnetic resonance imaging (MRI) brain scans, blood and cerebrospinal fluid (CSF) samples, and genetic testing. In addition, participants complete spontaneous speech recordings from home every 3-4 months using a dedicated mobile application.
The primary objective is to determine whether the stimulation program more effectively preserves memory and cognitive function compared to no intervention. The study also evaluates its impact on physical and emotional well-being, daily functioning, and quality of life. Insights from the trial will contribute to the development of an artificial intelligence (AI)-powered digital health platform aimed at delivering personalized care for individuals living with dementia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Active Functional Intervention | No intervention | –No stimulation activity |
| Active Functional Intervention | Experimental | Behavioral: Cognitive and functional stimulation using digital platformsStimulation activity |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 60 and 85 years.
- Diagnosis of MCI based on Petersen criteria with a CDR score of 0.5.
- Diagnosis of mild AD dementia according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria with a CDR score of 1.
- Proficiency in using digital tools such as mobile apps, tablets, or computers.
- Ability and willingness to attend regular in-person sessions at Ace Alzheimer Center Barcelona.
Key exclusion criteria (7 listed)
- History of traumatic brain injury.
- Diagnosis of severe depression.
- History of stroke or brain tumors.
- Presence of significant uncorrected visual or auditory impairments.
- Lack of access to a digital device or internet connection.
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 |
|---|---|---|
| Cognitive and functional stimulation using digital platformsParticipants in the intervention group receive personalized cognitive and functional stimulation over one year through digital platforms developed by the COMFORTage project. These include Eligence, a brain-training tool featuring interactive games targeting memory, attention, and language; Language Games, which assess and train linguistic and cognitive skills in realistic scenarios; and Healthentia, a platform that monitors daily health metrics and provides virtual coaching. Sessions are conducted both in person and remotely, and are adapted to each participant's abilities and level of digital literacy. The intervention aims to support cognitive health and daily functioning in individuals with MCI or mild AD. | Behavioural | Active Functional Intervention |
Primary outcome
Changes in neuropsychological assessment
Time frame: Baseline, 1-year follow-up, and 2-year follow-up
Assesses the change in cognitive function over two years using composite scores from the Neuropsychological Battery used at Ace (NBACE). The scores evaluate five domains: attention, memory, visuospatial/visuoperceptual functions, executive functions, and language. The scores for each domain range from -3 (low competence) to 3 (high competence).
17 secondary outcomes
Change in Mini-Mental State Examination (MMSE) score
Time frame: Baseline, 1-year follow-up, and 2-year follow-up
Change in Memory Test Score from the 7-Minute Screen Test (Spanish version)
Time frame: Baseline, 1-year follow-up, and 2-year follow-up
Change in Hachinski Ischemia Scale score
Time frame: Baseline, 1-year follow-up, and 2-year follow-up
Change in Neuropsychiatric Inventory Questionnaire (NPI-Q) score
Time frame: Baseline, 1-year follow-up, and 2-year follow-up
Change in Global Deterioration Scale (GDS) score
Time frame: Baseline, 1-year follow-up, and 2-year follow-up
Change in Clinical Dementia Rating (CDR) score
Time frame: Baseline, 1-year follow-up, and 2-year follow-up
Change in Blessed Dementia Scale score
Time frame: Baseline, 1-year follow-up, and 2-year follow-up
Change in Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) score
Time frame: Baseline, 1-year follow-up, and 2-year follow-up
Change in Cumulative Illness Rating Scale (CRIS) score
Time frame: Baseline, 1-year follow-up, and 2-year follow-up
Change in body weight
Time frame: Baseline, 1-year follow-up, and 2-year follow-up
Change in body height
Time frame: Baseline, 1-year follow-up, and 2-year follow-up
Change in abdominal circumference
Time frame: Baseline, 1-year follow-up, and 2-year follow-up
Change in blood pressure
Time frame: Baseline, 1-year follow-up, and 2-year follow-up
Questionnaire for User Interaction Satisfaction (QUIS)
Time frame: Baseline, 1-year follow-up, and 2-year follow-up
5-level EQ-5D (EQ5D5L) questionnaire
Time frame: Baseline, 1-year follow-up, and 2-year follow-up
Change in concentration of plasma biomarkers
Time frame: Baseline, 1-year follow-up, and 2-year follow-up
Basal evaluation of CSF biomarkers
Time frame: Once at the beginning of the study
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 22 Jun 2025.
- Derived from this study: PubMed 41669721Valero S, Miguel A, Blazquez-Folch J, Calm B, Alegret M, Solivar A, Manias G, Antoniades A, Angelova N, Psimaris D, Segkouli S, Morera A, Tantinya N, Rosende-Roca M, Cano A, Fernandez MV, Sanz-Cartagena P, Gurruchaga MJ, Tarraga L, Boada M, Ruiz A, Marquie M; and COMFORTage Consortium. The COMFORTage project: study protocol for the integration of multiple sources towards personalised preventions at Ace Alzheimer Center Barcelona. Front Digit Health. 2026 Jan 26;7:1633507. doi: 10.3389/fdgth.2025.1633507. eCollection 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive and functional stimulation using digital platforms in people with Alzheimer Disease and Mild Cognitive Impairment, run by Fundació ACE Institut Català de Neurociències Aplicades 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 7 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: opening soon, as of the sponsor's last update on 22 Jun 2025. 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?
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?
Contact Sergi Valero (934447318, svalero@fundacioace.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in neuropsychological assessment (time frame: Baseline, 1-year follow-up, and 2-year follow-up). 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 NCT07031167, 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 22 Jun 2025; AzTrials last refreshed its copy on 7 Nov 2026.