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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Active Functional Intervention | No Intervention | No stimulation activity | |
| Active Functional Intervention | Experimental | Stimulation activity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive and functional stimulation using digital platforms | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, 1-year follow-up, and 2-year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, 1-year follow-up, and 2-year follow-up |
| Change in Memory Test Score from the 7-Minute Screen Test (Spanish version) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in spontaneous speech evaluation | The speech assessment involves a picture description task where they describe a given image for one minute, followed by a category fluency task, listing as many items as possible within a given category, such as fruits or professions, within a minute. Finally, open-ended questions prompt participants to describe personal experiences and daily routines. All three tasks are completed within 3 minutes. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sergi Valero | Contact | 934447318 | svalero@fundacioace.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ace Alzheimer Centre Barcelona (Fundació ACE) | Barcelona | Barcelona | 08028 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41669721 | Derived | 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. |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
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). |
| 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). | 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. | 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). | 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). | 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). | 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. | 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. | 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). | 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). | Baseline, 1-year follow-up, and 2-year follow-up |
| Change in abdominal circumference | Measured in cm, this indicates central adiposity and metabolic risk. | 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). | 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). | 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). | 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). | 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. | Once at the beginning of the study |
| Every 3-4 months from baseline through 2 years |
| Changes in brain MRI | Evaluation of vascular contributions to cognitive impairment. | Once at the beginning of the study |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |