The COMFORTage Project at Ace Alzheimer Center Barcelona

Official title

The COMFORTage Project: Integration of Multiple Sources Towards Personalized Preventions at Ace Alzheimer Center Barcelona

Overview

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.

Interventions

• Behavioral 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 conduct

Primary outcome measures

• Changes in neuropsychological assessment [Time frame: Baseline, 1-year follow-up, and 2-year follow-up]

Secondary outcome measures (12)

• Change in Mini-Mental State Examination (MMSE) score [Time frame: Baseline, 1-year follow-up, and 2-year follow-up]
• Change in Memory Test Score from the 7-Minute Screen Test (Spanish version) [Time frame: Baseline, 1-year follow-up, and 2-year follow-up]
• Change in Hachinski Ischemia Scale score [Time frame: Baseline, 1-year follow-up, and 2-year follow-up]
• Change in Neuropsychiatric Inventory Questionnaire (NPI-Q) score [Time frame: Baseline, 1-year follow-up, and 2-year follow-up]
• Change in Global Deterioration Scale (GDS) score [Time frame: Baseline, 1-year follow-up, and 2-year follow-up]
• Change in Clinical Dementia Rating (CDR) score [Time frame: Baseline, 1-year follow-up, and 2-year follow-up]
• Change in Blessed Dementia Scale score [Time frame: Baseline, 1-year follow-up, and 2-year follow-up]
• Change in Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) score [Time frame: Baseline, 1-year follow-up, and 2-year follow-up]
• Change in Cumulative Illness Rating Scale (CRIS) score [Time frame: Baseline, 1-year follow-up, and 2-year follow-up]
• Change in body weight [Time frame: Baseline, 1-year follow-up, and 2-year follow-up]
• Change in body height [Time frame: Baseline, 1-year follow-up, and 2-year follow-up]
• Change in abdominal circumference [Time frame: Baseline, 1-year follow-up, and 2-year follow-up]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Spain · 1 center

• Ace Alzheimer Centre Barcelona (Fundació ACE) — Barcelona

Publications

• Valero S, Miguel A, Blazquez-Folch J, Calm B, Alegret M, Solivar A, Manias G, Antoniades A, Angelova N, Psimaris D, Segkouli S, Morera A, Tantinya N, Rosende-Roca M, Cano A, Fernandez MV, Sanz-Cartagena P, Gurruchaga MJ, Tarraga L, Boada M, Ruiz A, Marquie M; and COMFORTage Consortium. The COMFORTage project: study protocol for the integration of multiple sources towards personalised preventions a PMID 41669721

Identifiers

NCT: NCT07031167 · comfortage_ace_1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗