RecruitingPhase 3NCT07323914

Clinical Analgesic Management in Dementia

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


Sponsor

Xuanwu Hospital, Beijing

Enrollment

10 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is designed to assess the efficacy and safety of oxycodone in managing moderate to severe pain in patients with Alzheimer's disease. The trial will be conducted at Xuanwu Hospital, Capital Medical University, and will enroll 10 eligible participants. Participants will receive oxycodone/acetaminophen (5 mg/325 mg) once daily for 12 weeks. The treatment will follow international guidelines, with dosages adjusted based on the patient's baseline pain levels and individual needs. Dosages will be adjusted based on baseline pain levels and patient needs, following international guidelines. Efficacy and adverse events will be assessed at baseline, week 6, week 12, and at a 12-week post-treatment follow-up. The primary outcome is change in VAS pain scores; secondary outcomes include PAINAD, SF-36, functional ability, and safety profiles.


Eligibility

Min Age: 50 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how pain is managed in people who have Alzheimer's disease and also experience chronic pain. People with dementia often struggle to communicate their pain, which can lead to it being undertreated. The study is testing opioid-based pain therapy in this population. **You may be eligible if...** - You are 50–90 years old - You have been diagnosed with probable Alzheimer's disease (mild to moderate stage) - You have chronic pain that has been diagnosed within the past 6 months and is appropriate for opioid treatment - You have a reliable caregiver who spends at least 8 hours a week with you and can help with study participation - Any medications for your brain or mood have been at a stable dose for at least 3 months **You may NOT be eligible if...** - You had a stroke, TIA (mini-stroke), or seizure in the past 12 months - You have active hallucinations, severe depression, or delusions - You are allergic to opioid medications - You have severe hearing or vision problems - You have a history of alcohol or drug addiction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTylex

Tylenol (compound oxycodone/acetaminophen) is a non-narcotic analgesic that combines a lower dose of oxycodone (5 mg) with acetaminophen (325 mg). Compared to OxyContin, it provides milder opioid potency and utilizes a synergistic mechanism to achieve pain control with reduced risk of opioid-related side effects.


Locations(1)

Xuanwu Hospital, Capital Medical University

Beijing, China

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NCT07323914


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