NCT02719834

Behavioral Expressions in Alzheimer's Disease

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Acetaminophen	Acetaminophen (regular strength) will be provided in two capsules: 325 mg, take two capsules 3 times/day for 28 days (1,950 maximum daily dose). Capsules will be labeled to maintain blinding.
OTHER	Placebo	The placebo will be provided in the same type of capsules as the acetaminophen. Two capsules, given 3x a day for 28 days. Capsules will be labeled to maintain binding.

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-02-09
• Completion: 2018-02-01
• First posted: 2016-03-25
• Last updated: 2018-03-02

Locations

1 site across 1 country: United States