NCT07031167Not yet recruiting
The COMFORTage Project at Ace Alzheimer Center Barcelona
The COMFORTage Project: Integration of Multiple Sources Towards Personalized Preventions at Ace Alzheimer Center Barcelona
Source: ClinicalTrials.gov · Last updated 22 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 4 Jun 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 1 Jul 2028
- Lead sponsor
- Fundació ACE Institut Català de Neurociències Aplicades
- Diseases
- Alzheimer disease
- NCT number
- NCT07031167
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 1 Jul 2025 to the primary completion date, 1 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of traumatic brain injury.
- History of stroke or brain tumors.
- Any medical condition that may confound cognitive assessment or limit participation.
Other
- Diagnosis of severe depression.
- 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.
Who the study is looking for
- 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.
Age in the registry: 60 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ace Alzheimer Centre Barcelona (Fundació ACE) Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
Related publications
- The COMFORTage project: study protocol for the integration of multiple sources towards personalised preventions at Ace Alzheimer Center Barcelona.Front Digit Health · 2025 · PMID 41669721
This page is information, not medical advice. Discuss any trial with your doctor.