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CALM-D

RecruitingPhase 3

Clinical Analgesic Management in Dementia

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

Lead sponsor

Xuanwu Hospital, Beijing

Asset

Tylex

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Study partner/caregiver required

Primary endpoint

•Pain Assessment in Advanced Dementia Scale (PAINAD)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID2025005001

NCT IDNCT07323914

Timeline

Milestones

Study start2025-03-01actual

Study first posted2026-01-07actual

Last update posted2026-01-07actual

Primary completion2027-01-01estimated

Study completion2027-03-31estimated

Assets

Drug assets

Tylex

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Behavior / neuropsychiatric

Function / daily living

Amyloid biomarkers

Neurodegeneration biomarkers

Other clinical outcomes

Other (unclassified)

Global cognition

2 endpoints

Secondary/protocol endpoint

Change from baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)

Time frame:baseline; 6 weeks; 12 weeks; 24 weeks.

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline on the Mini Mental state Examination (MMSE) score

Time frame:baseline; 6 weeks; 12 weeks; 24 weeks.

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Function / daily living

1 endpoint

Secondary/protocol endpoint

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.

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

Mobilization-Observation-Behavior-Intensity-Dementia Pain Scale, version 2 (MOBID-2)

Time frame:baseline, 6 weeks, 12 weeks, 24 weeks.

descriptive

Secondary/protocol endpoint

Change from baseline on the Neuropaychiatic Inventory (NPI)

Time frame:baseline; 6 weeks; 12 weeks; 24 weeks.

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Amyloid biomarkers

1 endpoint

Secondary/protocol endpoint

Change from Baseline in Brain Amyloid Plaque Deposition as measured by PET Scan

Time frame:baseline; 12 weeks.

change from baseline, improvement

Neurodegeneration biomarkers

1 endpoint

Secondary/protocol endpoint

Changes from baseline of exploratory blood biomarkers

Time frame:baseline; 12 weeks.

descriptive

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

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, improvement

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

Pain Assessment in Advanced Dementia Scale (PAINAD)

Time frame:baseline, 6 weeks, 12 weeks, 24 weeks.

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.