PuntoCare: Digital support platform for mild cognitive impairment (MCI) and dementia (v1.0)

Eligibility criteria

Inclusion Criteria:
Patients:
1. Adults aged >=50 years
2. Capacity to provide informed consent
3. Individuals in one of the following groups, as determined through routine clinical assessment and application of the following criteria:
   - Subjective Cognitive Decline (SCD; also referred to as Subjective Memory Complaints, SMC):
     The following criteria will be used to define SCD (Jessen et al., 2014):
     (1) Self-experienced persistent decline in cognitive capacity compared with a previously normal status
     (2) Normal performance on standardised cognitive assessments
     (3) No significant impairment in activities of daily living
     (4) Absence of mild cognitive impairment or dementia
   - Mild Cognitive Impairment (MCI):
     An individual meeting the following diagnostic criteria will be identified as having MCI (Albert et al., 2011):
     (1) Concern regarding a change in cognition, whether reported by the self, informant, or clinician.
     (2) Objective evidence of impairment in one or more cognitive domains, typically including memory.
     (3) Preservation of independence in functional abilities.
     (4) Absence of dementia.
   - Mild dementia:
     An individual meeting the following diagnostic criteria will be identified as having mild dementia (DSM-5, 2013):
     (1) Evidence of cognitive decline from a previous level of performance, reported by the individual, an informant, or a clinician
     (2) Objective impairment in one or more cognitive domains (e.g. memory, attention, language, executive function)
     (3) Interference with independence in everyday activities (e.g. requiring assistance with complex tasks)
     (4) Not better explained by delirium or another mental disorder
   - Healthy controls:
     An individual meeting the following diagnostic criteria will be identified as a healthy control:
     (1) No self-reported cognitive concerns
     (2) Normal performance on a standardised cognitive assessment, defined as a score of >=27 on the Mini-Mental State Examination (MMSE) (Molloy & Standish, 1997)
     (3) No clinical diagnosis of mild cognitive impairment or dementia
     (4) Independent in activities of daily living
4. Sufficient proficiency in English to complete the study procedures and use the digital platform
5. Willingness and ability to engage with the PuntoCare digital platform over the study period
6. Access to a compatible smartphone capable of running the PuntoCare application, either personally or via a carer.
Carers (participation is voluntary and not required for patient enrolment):
1. Age >=18 years
2. Named carer of an eligible enrolled patient
3. Capacity to provide informed consent
4. Sufficient proficiency in English
5. Able and willing to participate in study procedures
Exclusion Criteria:
Patients:
1. Moderate or severe dementia, or any condition associated with lack of capacity to provide informed consent
2. Severe sensory, motor, or cognitive impairments that would prevent completion of the study procedures, including use of the digital assessment tools, even with support
3. Acute or unstable physical or mental health conditions that, in the opinion of the clinical team, would make participation inappropriate
Carers:
1. Lack capacity to provide informed consent

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2026-10-05