Clinician-Facilitated Intervention for Dementia

Overseen By James Wilkins, MD, DPhil

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mclean Hospital

Disqualifiers: No NPS, Long-term care, Psychiatric disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

20 Participants Needed

Trial Summary

What is the purpose of this trial?

Dementia is a disabling, progressive major neurocognitive disorder. Although cognitive symptoms drive the diagnosis of dementia, neuropsychiatric symptoms (NPS), such as depression, agitation/aggression, and psychosis, are common and associated with a number of significant adverse outcomes. There are currently extremely limited FDA (Food and Drug Administration)-approved treatments for NPS of dementia; there remains a critical need for safe and effective interventions for NPS that can be easily administered and monitored in typical clinical settings. As cognitive impairment progresses, persons living with dementia or cognitive impairment (PLWD/CI) increasingly rely on surrogate decision-makers, such that the quality of life for PLWD/CI is directly impacted by the decisions made by a surrogate. Discrepancy between preferences of PLWD/CI and proxy assessments by surrogate decision-makers is common. Our previous work has shown that such discrepancies in everyday preferences are associated with a higher burden of NPS for PLWD/CI. We hypothesize that discrepancy in everyday preferences assessment between PLWD/CI and care partners creates a set of "unmet needs" that increase the likelihood or severity of NPS; our preliminary data support this model of unmet needs as drivers of NPS. Specifically, as the neurodegenerative process disrupts the ability of PLWD/CI not only to provide for their own needs but also to communicate needs and preferences effectively to others, NPS may emerge in response. Thus, our hypothesis fits within a larger conceptual framework for understanding etiology of NPS: i.e., the mismatch between personality habits, physical/mental states, and environmental factors drive NPS as a means to resolve or communicate unmet needs. Building from this conceptual framework and our own preliminary data, the proposed pilot project addresses major gaps in the availability of safe, effective, and accessible strategies to reduce NPS by developing and testing the feasibility, acceptability, fidelity, and mechanistic target engagement of a templated, clinician-facilitated intervention to align everyday living preferences assessment between PLWD/CI and their care partners (n=20 dyads) to reduce NPS. The study is unique in developing a bioethics-driven intervention for NPS that is effective, portable, and easily transferrable to diverse settings. The crux of this intervention is meeting the needs of PLWD/CI by aligning everyday decision-making with priorities that matter most.

Research Team

James Wilkins, MD, DPhil

Principal Investigator

Mclean Hospital

Eligibility Criteria

This trial is for individuals aged 55 or older with mild cognitive impairment or mild to moderate dementia, who show signs of neuropsychiatric symptoms. They must have a MoCA score above 10 and an involved care partner (family, friend, caregiver) in regular contact at least three times a week.

Inclusion Criteria

I am 55 or older with mild to moderate memory problems and a MoCA score over 10.

I experience symptoms of dementia.

I have a care partner who knows me well and contacts me at least three times a week.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Intervention

Participants complete the PELI assessment to articulate preferences, and care partners complete proxy assessments. A clinician facilitates alignment of preferences.

8 weeks

3 visits (in-person or virtual)

Follow-up

Participants are monitored for changes in neuropsychiatric symptoms and alignment of preferences.

4 weeks

1 visit (in-person or virtual)

Treatment Details

Interventions

• Clinician-facilitated educational intervention
• Enhanced usual care

Trial Overview The study tests a new intervention where clinicians help align the everyday living preferences between people with dementia/cognitive impairment and their care partners. The goal is to reduce neuropsychiatric symptoms by addressing unmet needs through better decision-making alignment.

Participant Groups

Group I: Templated, clinician-facilitated intervention to align everyday living preferences assessment Experimental Treatment 1 Intervention

In step 1, persons living with dementia or cognitive impairment (PLWD/CI) will complete the PELI (hereafter, "assessment PELI-CI" for Cognitive Impairment) to articulate their preferences. In step 2, care partners will consider the preferences of PLWD/CI; care partners will complete concurrent but separate proxy PELI assessments from the perspective of the PLWD/CI (i.e., as if acting as surrogate decision-makers; hereafter "assessment PELI-CP" for Care Partner). In the Intervention (step 3), the study clinician will ask the PLWD/CI to identify up to 3 "social engagement" preferences that matter most to them. Second, in discussion with the PLWD/CI and care partner, the study clinician will review areas where there is a difference in ratings between the PELI-CI and PELI-CP. The study clinician will then ask the PLWD/CI to identify up to 3 items of disagreement that are most important for the care partner to know about. A 1-page Preferences Priorities document will then be created.

Who Is Running the Clinical Trial?

Mclean Hospital

Lead Sponsor

Trials

221

Recruited

22,500+