Ace Alzheimer Centre Barcelona (Fundació ACE)
Barcelona, 08028, Spain
NCT Number: NCT07031167
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.
Trial opening soon.
Get Notified60 year–85 year
All sexes
Interventional
Not applicable
Barcelona, 08028, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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).
Time frame: Baseline, 1-year follow-up, and 2-year follow-up
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
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
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
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
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
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
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
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
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
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
This supports anthropometric analysis by recording participants' height in centimeters (cm).
Time frame: Baseline, 1-year follow-up, and 2-year follow-up
Measured in cm, this indicates central adiposity and metabolic risk.
Time frame: Baseline, 1-year follow-up, and 2-year follow-up
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
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
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
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: Once at the beginning of the study
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: Every 3-4 months from baseline through 2 years
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.
Time frame: Once at the beginning of the study
Evaluation of vascular contributions to cognitive impairment.
Contact information is provided by the study sponsor or research team.
Fundació ACE Institut Català de Neurociències Aplicades
Other
The COMFORTage Project: Integration of Multiple Sources Towards Personalized Preventions at Ace Alzheimer Center Barcelona
Acronym: COMFORTage
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07652931
Alzheimer Disease, Behavior
Milan, Milano, Italy
View Trial DetailsNCT07361601
Alzheimer Disease, Brain Diseases
Chicago, Illinois, United States
View Trial DetailsNCT05899764
Alzheimer Disease, Brain Diseases
Los Angeles, California, United States
View Trial DetailsNCT06896201
Alzheimer Disease, Brain Diseases
View Trial Details