Oxycodone for managing pain in people with Alzheimer's disease

A Clinical Study on the Efficacy of Analgesic Treatments for Chronic Pain in Patients With Dementia

This trial will test whether a daily low-dose oxycodone/acetaminophen pill helps people with Alzheimer's disease who have moderate to severe chronic pain feel less pain over 12 weeks.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 50 Years to 90 Years
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07323914 on ClinicalTrials.gov

What this trial studies

This single-center, phase 3 interventional trial at Xuanwu Hospital will enroll 10 people with probable Alzheimer's disease and chronic moderate-to-severe pain. Participants will receive oxycodone/acetaminophen (5 mg/325 mg) once daily for 12 weeks with dose adjustments guided by baseline pain and international guidelines. Pain intensity (primary outcome: VAS) and secondary measures (PAINAD, MOBID-2, SF-36, functional ability) plus safety assessments will be recorded at baseline, week 6, week 12, and at a 12-week post-treatment follow-up. The trial includes only participants with a reliable caregiver and requires stable doses of permitted concomitant medications before enrollment.

Who should consider this trial

Good fit: Ideal candidates are people aged 50–90 with probable Alzheimer's disease (CDR global 0.5–2.0), documented chronic pain appropriate for opioid therapy, and a reliable caregiver to support participation.

Not a fit: Patients without chronic pain, those with dementia more severe than the enrolled CDR range, or people with contraindications to opioids or without caregiver support are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this treatment could reduce pain and improve daily functioning and quality of life for people with Alzheimer's disease who have chronic moderate-to-severe pain.

How similar studies have performed: Previous use of opioids for pain in dementia has produced mixed efficacy results and raised safety concerns, so evidence for clear benefit is limited but not entirely novel.

Eligibility criteria

Inclusion Criteria:

* Male or female, aged 50 to 90 years at the time of enrollment.
* Meets the NIA-AA core clinical diagnostic criteria for probable Alzheimer's disease.
* Clinical Dementia Rating - Global Score (CDR-GS) between 0.5 and 2.0, inclusive, and Clinical Dementia Rating - Memory Box (CDR-MB) score ≥ 0.5.
* Diagnosed with chronic pain within 6 months prior to enrollment and considered appropriate for opioid therapy.
* Presence and severity of pain confirmed using PAINAD, MOBID-2, or comparable scales.
* Educational attainment: at least 4-6 years of formal education, or not illiterate.
* If currently receiving psychotropic or cognitive-enhancing medications, the dosage must have been stable for at least 3 months prior to study entry and remain unchanged during the study. Unless otherwise specified, all other permitted concomitant medications (non-AD related) must be stably administered for at least 4 weeks prior to baseline.
* Has a reliable caregiver/companion who can assist with study participation, defined as a person who can support the participant throughout the study and spend at least 8 hours per week with the participant.
* Willing and able to participate in this clinical trial, to maintain the assigned intervention during the study period, and has signed the informed consent form.

Exclusion Criteria:

* History of transient ischemic attack (TIA), stroke, or seizure within the past 12 months.
* Presence of any psychiatric diagnosis or symptoms that may interfere with study participation (e.g., hallucinations, major depression, or delusions).
* Known allergy to opioid analgesics.
* Severe visual or hearing impairment.
* Alcohol dependence, substance abuse, or other drug addiction or addictive tendency.
* Current participation in another study related to the treatment of Alzheimer's disease.
* Any other uncontrolled or inadequately treated medical condition (e.g., cardiac, respiratory, gastrointestinal, hepatic, or renal disease), or any condition judged by the investigator to compromise participant safety or interfere with study assessments.
* Any other reason deemed by the investigator to preclude participation in the study.

Where this trial is running

Beijing

• Xuanwu Hospital, Capital Medical University — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Yi Tang, M.D., Ph.D.

Conditions: Alzheimer Disease, Alzheimer disease, chronic pain, opioid drugs