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Completed

Behavioral Expressions in Alzheimer's Disease

An Analgesic Trial to Reduce Pain and Behavior Disruptions in Nursing Home Residents With Alzheimer's Disease

Lead sponsor

University of Florida

Asset

Acetaminophen

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE ≤23

Primary endpoints

•Mobilization-Observation-Behaviour-Intensity-Dementia Pain Scale (MOBID-2) will•Cohen-Mansfield Agitation Inventory (CMAI) will be used for changes between

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

Other grant6AZ10Florida Department of Health

Org study IDIRB201600020

NCT IDNCT02719834

Timeline

Milestones

Study first posted2016-03-25estimated

Study start2016-04actual (month precision)

Primary completion2017-02-09actual

Study completion2018-02actual (month precision)

Last update posted2018-03-02actual

Assets

Drug assets

Acetaminophen

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•documented diagnosis of Alzheimer's Disease or other dementia

•history of a typically painful condition, such as osteoarthritis, back pain, or other chronic musculoskeletal pain

•able to swallow oral medication

•history of aggressive or agitated behavior (defined as score of > 39 on the Cohen-Mansfield Agitation Inventory),

•Mini Mental State Exam (MMSE) score < 23

Exclusion criteria

•currently taking acetaminophen or opioid medication on a routine (regularly-scheduled, round the clock) basis

•receiving hospice care

•history of liver or renal disease

•drinks more than 3 alcoholic beverages per day

•known allergy or adverse reaction to acetaminophen

•bed-ridden or comatose

•currently taking warfarin

Endpoints (2)

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.

Behavior / neuropsychiatric

2 endpoints

Primary/protocol endpoint

Mobilization-Observation-Behaviour-Intensity-Dementia Pain Scale (MOBID-2) will be used for changes between the groups at baseline, weeks 2, 4, 6 and 8

Time frame:Change from baseline, weeks 2, 4, 6 and 8

descriptive

Primary/protocol endpoint

Cohen-Mansfield Agitation Inventory (CMAI) will be used for changes between the groups at baseline, weeks 2,4, 6 and 8

Time frame:Change from baseline, weeks 2, 4, 6 and 8

event count, event

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.