An Integrated Solution for Sustainable Care for Multimorbid Elderly Patients With Dementia (CAREPATH)

This is an interventional treatment trial for Comorbidities and Coexisting Conditions focused on measuring Alzheimer Disease, Dementia, Quality of Life, Multimorbidity, Health monitoring, Home monitoring, Telemedicine Read More

Inclusion Criteria:

• Women and men aged ≥ 65 years old (randomization will warrant that at least 40% of each sex will be included in the study).
• Meets NIAAA core clinical criteria for probable Alzheimer disease, dementia or Mild Cognitive Impairment due to Alzheimer´s Disease (consistent with the NIAAA diagnostic criteria and guidelines for MCI; Albert MS, DeKosky ST, Dickson B, et al. The diagnosis of mild cognitive impairment due to Alzheimer's disease: Recommendations from the National Institute on Aging Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimer's & Dement 2011; 7: 270-9)
• Mild symptomatology, as defined by a screening MMSE score of ≥ 22 points and CDR-GS of 0.5 or 1.0.
• Evidence of retrospective decline in cognitive functions.
• Multimorbidity: Presence of at least one of the following chronic diseases: Diabetes mellitus needing pharmacologic treatment, hypertension needing pharmacologic treatment, heart failure NYHA class 2-4, atrial fibrillation with a CHA2DS2-Vasc, chronic obstructive pulmonary disease (COPD) GOLD staging B-D, asthma needing pharmacologic treatment or chronic kidney disease (CKD) stage III-V.
• Living at home.
• Independence for basic activities of daily living.

• Availability of a person (referred to as the "caregiver" throughout this protocol) who in the investigator's judgment:

  • Has frequent and sufficient contact with the patient to be able to provide accurate information regarding the patient's cognitive and functional abilities, agrees to provide information at clinic visits (which require partner input for scale completion), signs the necessary consent form, and has sufficient cognitive capacity to accurately report upon the patient's behavior and cognitive and functional abilities.
  • Is in sufficiently good general health to have a high likelihood of maintaining the same level of interaction with the patient and participation in study procedures throughout the study duration.
  • Note that every effort should be made to have same caregiver participate throughout the duration of the study.
• Fluency in the language used at the study site.
• Willingness and ability to complete all aspects of the study; the patient should be capable of completing assessments either alone or with the help of the caregiver.
• Adequate visual and auditory acuity, in the investigator's judgement, sufficient to perform the neuropsychological testing (eye glasses and hearing aids are permitted).
• Patient must have completed at least 6 years of formal education after the age of 5 years.

• Able to provide written consent signed by the patient (co-signed by the patient's legally authorized representative, if required by the local regulations, guidelines, and independent ethics committee or institutional review board [IRB]).

  • Patients should be judged by the investigator to be lucid and oriented to person, place, time, and situation when giving the informed consent.
  • In judging capacity, the investigator must confirm that the patient is able to understand the information relevant to the decision to participate in the study, appreciate the situation in terms of the treatment and research options and their likely outcomes, and weigh the potential risks and benefits of participation in order to come to a decision and communicate that decision.

Exclusion Criteria:

• Any evidence of established dementia, including but not limited to, frontotemporal dementia, dementia with Lewy bodies, vascular dementia, Parkinson's disease, corticobasal degeneration, Creutzfeldt-Jakob disease, progressive supranuclear palsy, frontotemporal degeneration, Huntington's disease, normal pressure hydrocephalus, seizure disorder, or hypoxia. Presence of cerebral tumors, trauma, infections, autoimmune diseases or vitamin deficits (B12, folate…) affecting cognition.
• At risk of suicide in the opinion of the investigator.
• Inadequate home infrastructure to host the required technology.
• Inability to understand how to use the CAREPATH system.

• Illness that impedes carrying out the study:

  • Active cancer of any type except non-melanoma skin cancer.
  • Terminal disease (<12 months of life expectancy).
  • Other pathologies involving clinical instability.
• Psychiatric disorders or alcohol/drugs abuse.
• Living with a participant.
• Participation in other interventional clinical studies