Alzheimer DiseasePhase 3CALM-DNCT07323914
Clinical Analgesic Management in Dementia
A Phase 3 study testing Tylex in people with Alzheimer Disease, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Tylex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 31 Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing
Yi Tang, M.D., Ph.D., 00861083199456, tangyixw@vip.163.com
About this study
Official title: A Clinical Study on the Efficacy of Analgesic Treatments for Chronic Pain in Patients With Dementia
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.
- Conditions
- Alzheimer Disease
- Being tested
- Tylex
- Keywords
- Alzheimer disease, chronic pain, opioid drugs
- Medical subject headings
- Alzheimer Disease, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TylexDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Tylex group | Experimental | Not described Receives: Drug: Tylex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Assessment in Advanced Dementia Scale (PAINAD)
Measured: baseline, 6 weeks, 12 weeks, 24 weeks.
Secondary outcomes (8)
Changes from baseline of exploratory blood biomarkers
Description: Exploratory blood biomarkers related to astrocyte-neuron interactions will be assessed using the SomaScan 11k platform. These include glial fibrillary acidic protein (GFAP), S100B, YKL-40, β-synuclein, neuregulin 1, GluN2A, and neurogranin.
Measured: baseline; 12 weeks.
Mobilization-Observation-Behavior-Intensity-Dementia Pain Scale, version 2 (MOBID-2)
Measured: baseline, 6 weeks, 12 weeks, 24 weeks.
Change from Baseline in Brain Amyloid Plaque Deposition as measured by PET Scan
Measured: baseline; 12 weeks.
Change from baseline on the Neuropaychiatic Inventory (NPI)
Measured: baseline; 6 weeks; 12 weeks; 24 weeks.
Change from baseline on the Alzheimer's Disease Cooperative study-Activities of Daily Living Scale(ADCS-ADL)
Measured: baseline; 6 weeks; 12 weeks; 24 weeks.
Change from baseline on the Alzheimer's Disease Cooperative study-clinical global impression of change scale(ADCS-CGIC)
Measured: baseline; 6 weeks; 12 weeks; 24 weeks.
Change from baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)
Measured: baseline; 6 weeks; 12 weeks; 24 weeks.
Change from baseline on the Mini Mental state Examination (MMSE) score
Measured: baseline; 6 weeks; 12 weeks; 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Mar 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi Tang, Study chair, M.D., Ph.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323914
- Sponsor's protocol ID
- 2025005001
- Acronym
- CALM-D
- Status last verified
- Jan 2025
- First submitted
- 23 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Efficacy of Analgesic Treatments for Chronic Pain in Patients With Dementia
- ClinicalTrials.gov ID
- NCT07323914
- Acronym / sponsor ID
- CALM-D / 2025005001
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer disease, chronic pain, opioid drugs
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tylex group | Experimental | Drug: Tylex |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TylexTylenol (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. | Drug | Tylex group |
Primary outcome
Pain Assessment in Advanced Dementia Scale (PAINAD)
Time frame: baseline, 6 weeks, 12 weeks, 24 weeks.
8 secondary outcomes
Changes from baseline of exploratory blood biomarkers
Time frame: baseline; 12 weeks.
Mobilization-Observation-Behavior-Intensity-Dementia Pain Scale, version 2 (MOBID-2)
Time frame: baseline, 6 weeks, 12 weeks, 24 weeks.
Change from Baseline in Brain Amyloid Plaque Deposition as measured by PET Scan
Time frame: baseline; 12 weeks.
Change from baseline on the Neuropaychiatic Inventory (NPI)
Time frame: baseline; 6 weeks; 12 weeks; 24 weeks.
Change from baseline on the Alzheimer's Disease Cooperative study-Activities of Daily Living Scale(ADCS-ADL)
Time frame: baseline; 6 weeks; 12 weeks; 24 weeks.
Change from baseline on the Alzheimer's Disease Cooperative study-clinical global impression of change scale(ADCS-CGIC)
Time frame: baseline; 6 weeks; 12 weeks; 24 weeks.
Change from baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)
Time frame: baseline; 6 weeks; 12 weeks; 24 weeks.
Change from baseline on the Mini Mental state Examination (MMSE) score
Time frame: baseline; 6 weeks; 12 weeks; 24 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yi Tang study chair
M.D., Ph.D.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tylex in people with Alzheimer Disease, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Tang, M.D., Ph.D. (00861083199456, tangyi@xwhosp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Assessment in Advanced Dementia Scale (PAINAD) (time frame: baseline, 6 weeks, 12 weeks, 24 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.