Clinical trial NCT02719834: Behavioral Expressions in Alzheimer's Disease
Official title: An Analgesic Trial to Reduce Pain and Behavior Disruptions in Nursing Home Residents With Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Florida Department of Health
First posted: 2016-03-25
Enrollment: 4
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will recruit study participants from senior communities in the Gainesville area.

Brief summary: Behavioral expressions, such as agitation and aggression, affect up to 90% of persons with dementia and are a major source of patient and caregiver distress, nursing home placement, anti-psychotic medication use, restraints, and increased health care costs. The purpose of the research study is to investigate whether reducing pain reduces behavioral expressions of Alzheimer's disease (agitation and aggression).

Detailed description: The research study will investigate if routine analgesic use will reduce behavioral expressions of dementia and pain in older adults with Alzheimer's disease or other dementias. Using a randomized, placebo-controlled, double-blind, cross-over design, the investigators will compare effects of a routine acetaminophen intervention (650 mg administered routinely by mouth three times per day for 4 weeks) to those of routine placebo (methylcellulose), also given for 4 weeks. The maximum dose to be administered will be 1,950 mg per 24 hours, which is below the current FDA recommendations (maximum dose of 3,000 mg/day).

Participants will be randomly assigned to either treatment or placebo group. The initial treatment phase will last for 4 weeks. At the end of the first 4 weeks, the treatment will be reversed after a 3 day washout period. During the 2nd intervention period, the study drug will be reversed (those receiving acetaminophen will receive the placebo drug and vice versa). The second treatment phase will last for 4 weeks. At the end of 2nd treatment phase, all study treatments will be discontinued

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Change from baseline, weeks 2, 4, 6 and 8
measure: Cohen-Mansfield Agitation Inventory (CMAI) will be used for changes between the groups at baseline, weeks 2,4, 6 and 8
timeFrame: Change from baseline, weeks 2, 4, 6 and 8
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Oak Hammock Continuing Care Retirement Faculty
state: Florida
Study officials:
affiliation: University of Florida
name: Ann Horgas-Marsiske, RN PhD
role: PRINCIPAL_INVESTIGATOR
References: