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New hope for Alzheimer's pain: opioid combo trial launches

NCT ID NCT07323914

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial at Xuanwu Hospital in Beijing is testing whether a combination painkiller (oxycodone/acetaminophen) can safely ease chronic pain in 10 people with Alzheimer's disease. Participants will take the medication once daily for 12 weeks, with pain levels and side effects checked at several points. The goal is to find a better way to manage pain in patients who often cannot communicate their discomfort clearly.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
oxycodone/acetaminophen (Tylex)
What this could lead to
If successful, this could provide a safe and effective way to manage chronic pain in people with Alzheimer's disease, improving their comfort and quality of life.
What could go wrong
This is a very small trial with only 10 participants, so results may not apply to everyone. Opioids carry risks like drowsiness, falls, and dependence, especially in older adults with dementia.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Chronic Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Xuanwu Hospital, Capital Medical University

    RECRUITING

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.