The COMFORTage Project at Ace Alzheimer Center Barcelona

NCT07031167 | Not Yet Recruiting

• 1 other identifier: comfortage_ace_1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline, 1-year follow-up, and 2-year follow-up

Secondary Outcomes (17)

• Change in Mini-Mental State Examination (MMSE) score

  Baseline, 1-year follow-up, and 2-year follow-up

• Change in Memory Test Score from the 7-Minute Screen Test (Spanish version)

  Baseline, 1-year follow-up, and 2-year follow-up

• Change in Hachinski Ischemia Scale score

  Baseline, 1-year follow-up, and 2-year follow-up

• Change in Neuropsychiatric Inventory Questionnaire (NPI-Q) score

  Baseline, 1-year follow-up, and 2-year follow-up

• Change in Global Deterioration Scale (GDS) score

  Baseline, 1-year follow-up, and 2-year follow-up

Other Outcomes (2)

• Changes in spontaneous speech evaluation

  Every 3-4 months from baseline through 2 years

• Changes in brain MRI

  Once at the beginning of the study

Study Arms (2)

Non-Active Functional Intervention

NO INTERVENTION

No stimulation activity

Active Functional Intervention

EXPERIMENTAL

Stimulation activity

Behavioral: Cognitive and functional stimulation using digital platforms

Interventions

Cognitive and functional stimulation using digital platforms 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.

Active Functional Intervention

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundació ACE Institut Català de Neurociències Aplicades: lead

Study Sites (1)

Ace Alzheimer Centre Barcelona (Fundació ACE)

Barcelona, Barcelona, 08028, Spain

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Central Study Contacts

Sergi Valero

CONTACT

934447318; svalero@fundacioace.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 22, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

ES (1)