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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tylex group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tylex | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Assessment in Advanced Dementia Scale (PAINAD) | baseline, 6 weeks, 12 weeks, 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline; 12 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Tang, M.D., Ph.D. | Contact | 00861083199456 | tangyi@xwhosp.org | |
| Ouyang Chen, Ph.D. | Contact | 15652888562 | chenouyang@xwhosp.org |
| Name | Affiliation | Role |
|---|---|---|
| Yi Tang | M.D., Ph.D. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Mobilization-Observation-Behavior-Intensity-Dementia Pain Scale, version 2 (MOBID-2) |
| baseline, 6 weeks, 12 weeks, 24 weeks. |
| Change from Baseline in Brain Amyloid Plaque Deposition as measured by PET Scan | baseline; 12 weeks. |
| Change from baseline on the Neuropaychiatic Inventory (NPI) | baseline; 6 weeks; 12 weeks; 24 weeks. |
| Change from baseline on the Alzheimer's Disease Cooperative study-Activities of Daily Living Scale(ADCS-ADL) | 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) | baseline; 6 weeks; 12 weeks; 24 weeks. |
| Change from baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) | baseline; 6 weeks; 12 weeks; 24 weeks. |
| Change from baseline on the Mini Mental state Examination (MMSE) score | baseline; 6 weeks; 12 weeks; 24 weeks. |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |