Testing PMI@Home with Brain Health Pro against a placebo for mild cognitive impairment

Inclusion

• +Ages 60-85 years.
• +Absence of clinical dementia per DSM-IV criteria †Objective cognitive impairment is operationalized as: Montreal Cognitive Assessment (MoCA) total score between 16 and 25 (inclusive), and/or RAVLT delayed recall ≤6, and /or Clinical Dementia Rating Scale (CDR) =0.5
• +Having mild cognitive impairment (MCI) defined as meeting all of the following:
• +Presence of subjective memory complaints from the participant and/or informant.
• +Objective impairment on cognitive tests independent of outcome measuresEndpointThe specific thing a study measures to answer its question.Read more →.†
• +Preserved activities of daily living assessed (\>14/23 in Lawton-Brody IADL score). For the study, impairment of daily living will be assessed based on cognitive abilities, not physical abilities.
• +Have access to a home computer/laptop/tablet with home internet (have regular access to email) and ability to use technology (able to send and receive emails and join video conferences).
• +Self-reported levels of proficiency in English for speaking and understanding spoken and written language.
• +Have normal/corrected to normal vision in at least one eye to identify stimuli on computer/tablet screen.
• +Have normal to corrected hearing ability, in order for the participant to engage in digital/virtual communication. Research personnel will determine and assess the hearing ability as per participant's performance.
• +Able to comply with virtual visits, treatment plan, and trial-related activities.
• +Ability to participate in the study's exercise training as determined by the Get Active Questionnaire (GAQ).
• +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
• +Having a diagnosis of dementia (based on DSM-IV criteria).
• +Underlying severe disease that precludes engagement with interventions, including presence of psychiatric diagnoses (i.e., major depression (Geriatric Depression Scale (GDS-30) \>19), schizophrenia, severe anxiety, neurological disorder with severe motor deficits, such as current parkinsonism or any neurological disorder with residual severe motor deficits (i.e., stroke with motor deficit), or presence of unstable (non-controlled e.g., symptoms that suggest instability or no treatment for their condition) chronic disease such as congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) that may preclude the participant from engaging properly with the trial interventions, or advanced-stage active cancer that at the study physician's discretion will prevent them from participating.
• +Regular use of Benzodiazepine or neuroleptic drugs that may interfere with the participants ability to participate in the assessments and interventions.
• +Recent (in the past 12 months) and/or current substance or alcohol abuse.
• +Having had a transmural myocardial infarction (severe heart attack) within six months prior to enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → in the clinical trialInterventional studyA study where participants are given something to see what happens.Read more → that according to the study physician may preclude physical activity performance.
• +Intention to enroll in other interventional clinical trials during same time.
• +Having had surgery within the last 2 months or having an upcoming planned surgery in the next 12 months that could interfere with the participant's vision, hearing, mobility, or any other abilities to participate in the study.
• +Have ≥1 additional dementia risk factors targeted by our intervention as follows: low physical activity (less than 150 minutes of moderate-to-vigorous-intensity physical activity per week, as per GAQ), poor diet (14-item Mediterranean Diet Assessment (MDA-14) score ≤7), insomnia or subthreshold insomnia ( Insomnia Severity Index (ISI) score \>7), and vascular-metabolic risk (Cardiovascular Risk Factors Aging and Incidence of Dementia (CAIDE) score ≥6 and/or diabetes (type I or II) and/or obesity (BMI≥30) and/or diagnosis of high blood pressure (hypertension) and/or smoking).