Eligibility, any sex, with Dementia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Severity of Dementia-related Behavioral SymptomsPrimary· Baseline
The severity of symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Severity (NPI-Q Severity). The NPI-Q Severity is a validated survey that assesses the caregiver's perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score ranges from 0-36 with higher scores indicating more severe symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data
Group
Value
95% CI
Health Systems-Based Dementia Care
10.32
± 0.22
Community-Based Dementia Care
9.93
± 0.21
Usual Care
10.42
± 0.56
Severity of Dementia-related Behavioral SymptomsPrimary· 3-month
The severity of symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Severity (NPI-Q Severity). The NPI-Q Severity is a validated survey that assesses the caregiver's perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score ranges from 0-36 with higher scores indicating more severe symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data
Group
Value
95% CI
Health Systems-Based Dementia Care
9.10
± 0.24
Community-Based Dementia Care
8.98
± 0.22
Usual Care
9.67
± 0.65
Severity of Dementia-related Behavioral SymptomsPrimary· 6-month
The severity of symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Severity (NPI-Q Severity). The NPI-Q Severity is a validated survey that assesses the caregiver's perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score ranges from 0-36 with higher scores indicating more severe symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data
Group
Value
95% CI
Health Systems-Based Dementia Care
9.41
± .25
Community-Based Dementia Care
8.78
± .23
Usual Care
9.93
± .68
Severity of Dementia-related Behavioral SymptomsPrimary· 12-month
The severity of symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Severity (NPI-Q Severity). The NPI-Q Severity is a validated survey that assesses the caregiver's perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score ranges from 0-36 with higher scores indicating more severe symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data
Group
Value
95% CI
Health Systems-Based Dementia Care
9.58
± .27
Community-Based Dementia Care
9.14
± .25
Usual Care
9.95
± .74
Severity of Dementia-related Behavioral SymptomsPrimary· 18-month
The severity of symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Severity (NPI-Q Severity). The NPI-Q Severity is a validated survey that assesses the caregiver's perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score ranges from 0-36 with higher scores indicating more severe symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data
Group
Value
95% CI
Health Systems-Based Dementia Care
9.80
± 0.29
Community-Based Dementia Care
9.51
± 0.27
Usual Care
9.60
± 0.79
Severity of Dementia-related Behavioral Symptoms (Common Baseline)Primary· Baseline
The severity of symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Severity (NPI-Q Severity). The NPI-Q Severity is a validated survey that assesses the caregiver's perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score ranges from 0-36 with higher scores indicating more severe symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data
Group
Value
95% CI
Common Baseline
10.07
9.71 – 10.43
Severity of Dementia-related Behavioral SymptomsPrimary· Average of 3M, 6M, 12M, and 18M least square means.
The severity of symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Severity (NPI-Q Severity). The NPI-Q Severity is a validated survey that assesses the caregiver's perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score ranges from 0-36 with higher scores indicating more severe symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data
Group
Value
95% CI
Health Systems-Based Dementia Care
9.79
9.37 – 10.22
Community-Based Dementia Care
9.50
9.08 – 9.91
Usual Care
10.12
9.15 – 11.08
Caregiver Distress/StrainPrimary· Baseline
The level of caregiver distress/strain as measured by the Modified Caregiver Strain Index (MCSI). The MCSI is a 13-item validated tool used to assess severity of caregiver strain. The index targets financial, physical, psychological, and social aspects of strain and is scored from 0 to 26 with higher scores indicating greater levels of strain. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of
Group
Value
95% CI
Health Systems-Based Dementia Care
11.03
± 0.20
Community-Based Dementia Care
10.65
± 0.19
Usual Care
11.13
± 0.55
Caregiver Distress/StrainPrimary· 3-month
The level of caregiver distress/strain as measured by the Modified Caregiver Strain Index (MCSI). The MCSI is a 13-item validated tool used to assess severity of caregiver strain. The index targets financial, physical, psychological, and social aspects of strain and is scored from 0 to 26 with higher scores indicating greater levels of strain. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of
Group
Value
95% CI
Health Systems-Based Dementia Care
10.52
± 0.22
Community-Based Dementia Care
10.01
± 0.20
Usual Care
10.00
± 0.53
Caregiver Distress/StrainPrimary· 6-month
The level of caregiver distress/strain as measured by the Modified Caregiver Strain Index (MCSI). The MCSI is a 13-item validated tool used to assess severity of caregiver strain. The index targets financial, physical, psychological, and social aspects of strain and is scored from 0 to 26 with higher scores indicating greater levels of strain. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of
Group
Value
95% CI
Health Systems-Based Dementia Care
10.61
± 0.23
Community-Based Dementia Care
10.26
± 0.22
Usual Care
10.53
± 0.65
Caregiver Distress/StrainPrimary· 12-month
The level of caregiver distress/strain as measured by the Modified Caregiver Strain Index (MCSI). The MCSI is a 13-item validated tool used to assess severity of caregiver strain. The index targets financial, physical, psychological, and social aspects of strain and is scored from 0 to 26 with higher scores indicating greater levels of strain. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of
Group
Value
95% CI
Health Systems-Based Dementia Care
11.00
± 0.24
Community-Based Dementia Care
10.50
± 0.24
Usual Care
10.41
± 0.69
Caregiver Distress/StrainPrimary· 18-month
The level of caregiver distress/strain as measured by the Modified Caregiver Strain Index (MCSI). The MCSI is a 13-item validated tool used to assess severity of caregiver strain. The index targets financial, physical, psychological, and social aspects of strain and is scored from 0 to 26 with higher scores indicating greater levels of strain. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of
Group
Value
95% CI
Health Systems-Based Dementia Care
11.26
± 0.26
Community-Based Dementia Care
10.64
± 0.24
Usual Care
10.32
± 0.72
Adverse events — posted to ClinicalTrials.gov
Time frame: Enrollment through death, withdrawal, or 18 months of follow-up.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Health Systems-Based Dementia Care
Serious: 528/1016 (52%)
Deaths: 254/1016
Community-Based Dementia Care
Serious: 533/1016 (52%)
Deaths: 223/1016
Usual Care
Serious: 70/144 (49%)
Deaths: 37/144
Serious adverse events (32 terms)
Reaction
System
Health Systems-Based Demen…
Community-Based Dementia C…
Usual Care
Falls or fractures
Musculoskeletal and connective tissue disorders
—
—
—
Infection
Infections and infestations
—
—
—
Neurologic
Nervous system disorders
—
—
—
Cardiopulmonary
Cardiac disorders
—
—
—
Gastroenterologic
Gastrointestinal disorders
—
—
—
Cardiopulmonary
Respiratory, thoracic and mediastinal disorders
—
—
—
Unknown/Other
General disorders
—
—
—
COVID-19
Infections and infestations
—
—
—
Renal or electrolytes
Renal and urinary disorders
—
—
—
Neuropsychiatric complications of dementia
Psychiatric disorders
—
—
—
Surgical procedure other than fracture repair
Surgical and medical procedures
—
—
—
Muskuloskeletal
Musculoskeletal and connective tissue disorders
—
—
—
Unknown/Other
Infections and infestations
—
—
—
Endocrine or Metabolic
Endocrine disorders
—
—
—
Unknown/Other
Musculoskeletal and connective tissue disorders
—
—
—
Oncologic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
D-CARE: The Dementia Care Study
This pragmatic randomized clinical trial of 2150 persons with dementia and their caregivers, at four diverse clinical trial sites in the United States, compares the effectiveness and cost-effectiveness of 18 months of health systems-based dementia care provided by a Dementia Care Specialist (nurse practitioner or physician assistant) who works within the heath system versus community-based dementia care provided by a Care Consultant (social worker, nurse, or therapist) who works at a Community-Based Organization (CBO).
The trial will also compare the effectiveness and cost-effectiveness of both models versus usual care.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07531589 — BrainLive Connect: Non-professional Delivered CST for People Living With Dementia
· NA
· recruiting
NCT07290387 — Tele-Savvy for Latino Caregivers
· NA
· recruiting
NCT06088810 — The Impact of Music Intervention on Sleep
· NA
· recruiting
NCT07482800 — Dementia in Fiction and Clinical Narratives
· recruiting
NCT07392944 — Multicomponent Exercise Program on Physical Function, Cognition and Falls Risk Among Older Adults Living in Nursing Home
· NA
· recruiting
Other University of California, Los Angeles trials
Trials by the same sponsor.
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· NA
· not yet recruiting
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· Phase 2
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· Phase 2
· withdrawn
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· Phase 1
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NCT07534696 — Evaluation of Non-Invasive Pelvic Floor Neuromuscular Stimulation for Urinary Incontinence After Prostatectomy
· NA
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of California, Los Angeles
Last refreshed: 30 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03786471.