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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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.
Ace Alzheimer Centre Barcelona (Fundació ACE)
Barcelona, Barcelona, Spain
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).
Time frame: Baseline, 1-year follow-up, and 2-year follow-up
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).
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)
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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: Baseline, 1-year follow-up, and 2-year follow-up
Change in abdominal circumference
Measured in cm, this indicates central adiposity and metabolic risk.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: Once at the beginning of the study
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