The COMFORTage Project: Integration of Multiple Sources Towards Personalized Preventions at Ace Alzheimer Center Barcelona
Trial ID: NCT07031167
Status: NOT_YET_RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2025-07-01
Completion date: 2028-07-01
Sponsor: Fundació ACE Institut Català de Neurociències Aplicades
Conditions: Alzheimer Disease; Mild Cognitive Impairment
Interventions: Cognitive and functional stimulation using digital platforms
Locations: Ace Alzheimer Centre Barcelona (Fundació ACE)
Countries: Spain
Enrollment: 100
Age range: 60 Years - 85 Years
Sex: ALL

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.

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.

Eligibility criteria:
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Outcomes:
Changes in neuropsychological assessment