Trial results for a study investigating a palliative care program for persons with late-stage Alzheimer's and related dementias (ADRD) and their caregivers were posted on ClinicalTrials.gov on 2025-12-16. The program demonstrated a statistically significant improvement in patient symptom treatment, with a mean score of 8.06 compared to 6.49 in the control group (p=0.001).
Background
Millions of Americans live with late-stage Alzheimer's and related dementias (ADRD), a condition characterized by progressive loss of self-awareness, increasing dependency, and a range of physical and neuropsychiatric symptoms. This stage of the disease often leads to significant suffering for patients and imposes substantial physical, emotional, and financial strain on their family caregivers. Addressing these multifaceted challenges through comprehensive support is crucial for improving quality of life for both patients and their caregivers.
Trial design
This completed study, designated as Phase NA, enrolled 884 participants to investigate conditions including Dementia, Vascular Dementia, Dementia With Lewy Bodies, Frontal Dementia, and Mixed Dementia. The trial evaluated the ADRD Palliative Care (ADRD-PC) program, which was triggered during hospitalization and included dementia-specific palliative care, standardized caregiver education, and transition support. Participants in the intervention group received the ADRD-PC program, while those in the control group received standard care.
Key results
The trial reported several key measurements:
- Incidence of Hospital Transfers (Patients):
- In the Intervention Condition (ADRD-PC Program), the incidence was 0.99 events per person day at risk.
- In the Control Condition, the incidence was 1.12 events per person day at risk.
- Analysis using Poisson regression showed a p-value of 0.522.
- Symptom Treatment (Patients):
- In the Intervention Condition (ADRD-PC Program), the mean score on a scale was 8.06 (Standard Deviation 2.14).
- In the Control Condition, the mean score on a scale was 6.49 (Standard Deviation 2.27).
- Analysis using a t-test (2 sided) showed a p-value of 0.001.
- Symptom Control for Physical Symptoms (Patients):
- In the Intervention Condition (ADRD-PC Program), the mean score on a scale was 21.0 (Standard Deviation 9.08).
- In the Control Condition, the mean score on a scale was 21.8 (Standard Deviation 9.25).
- Analysis using a t-test (2 sided) showed a p-value of 0.402.
- Symptom Control for Neuropsychiatric Symptoms-Severity (Patients):
- In the Intervention Condition (ADRD-PC Program), the mean score on a scale was 21.6 (Standard Deviation 5.83).
- In the Control Condition, the mean score on a scale was 21.8 (Standard Deviation 5.87).
- Analysis using a t-test (2 sided) showed a p-value of 0.803.
- Symptom Control for Neuropsychiatric Symptoms-Distress (Patients):
- In the Intervention Condition (ADRD-PC Program), the mean score on a scale was 24.9 (Standard Deviation 13.7).
- In the Control Condition, the mean score on a scale was 27.7 (Standard Deviation 13.8).
- Analysis using a t-test (2 sided) showed a p-value of 0.045.
- Access to Hospice (Patients):
- In the Intervention Condition (ADRD-PC Program), 17.2 percentage of participants accessed hospice.
- In the Control Condition, 17.6 percentage of participants accessed hospice.
- Analysis using Chi-squared showed a p-value of 0.977.
What this means
The ADRD Palliative Care program demonstrated a statistically significant improvement in overall symptom treatment for patients with late-stage Alzheimer's and related dementias, as well as a significant reduction in neuropsychiatric symptom distress. While the intervention group showed a numerically lower incidence of hospital transfers, this difference did not reach statistical significance. Similarly, there were no significant differences observed in physical symptom control or access to hospice care between the intervention and control groups. These findings suggest that comprehensive palliative care interventions can play a meaningful role in enhancing symptom management and reducing distress for patients and their caregivers in the challenging context of advanced dementia.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04948866, titled "Palliative Care for Persons With Late-stage Alzheimer's and Related Dementias and Their Caregivers", were posted on 2025-12-16 on clinicaltrials.gov.