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Withdrawn Not applicable Interventional

An Intervention to Reduce Discrepancy in Everyday Preferences

ClinicalTrials.gov ID: NCT03577418

Public ClinicalTrials.gov record NCT03577418. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 4:26 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03577418
Recruitment status
Withdrawn
Study type
Interventional
Phase
Not applicable
Lead sponsor
Mclean Hospital
Other
Enrollment
Not listed

Conditions and interventions

Eligibility (public fields only)

Age range
55 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2026
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028
Last update posted
Jun 29, 2026

2026 – 2028

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
McLean Hospital Belmont Massachusetts 02478

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03577418, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 29, 2026 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03577418 live on ClinicalTrials.gov.

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