The COMFORTage Project at Ace Alzheimer Center Barcelona

NCT ID: NCT07031167

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2028-07-01

Brief 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.

Conditions

Alzheimer Disease; Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Non-Active Functional Intervention

No stimulation activity

Group Type: NO_INTERVENTION

No interventions assigned to this group

Active Functional Intervention

Stimulation activity

Group Type: EXPERIMENTAL

Cognitive and functional stimulation using digital platforms

Intervention Type: 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.

Interventions

Cognitive and functional stimulation using digital platforms

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundació ACE Institut Català de Neurociències Aplicades

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ace Alzheimer Centre Barcelona (Fundació ACE)

Barcelona, Barcelona, Spain

Countries

Spain

Central Contacts

Sergi Valero

Role: CONTACT

svalero@fundacioace.org

934447318

Facility Contacts

Sergi Valero

Role: primary

svalero@fundacioace.org

934447318

Other Identifiers

comfortage_ace_1

Identifier Type: -

Identifier Source: org_study_id