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Completed

NCT Number: NCT02719834

Behavioral Expressions in Alzheimer's Disease

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).

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oak Hammock Continuing Care Retirement Faculty

Gainesville, Florida, 32607, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetaminophen

Drug

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 names: Tylenol

Placebo

Other

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.

Other names: Methycellulose

Primary outcomes

  1. 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

    The MOBID-2 is a two-part, observational pain behavior measure. Part 1 assesses pain related to the musculoskeletal system (the most common cause of pain in older adults) during a set of standardized, guided movements during morning care (5 items). Part 2 assesses pain that might originate from internal organs, head, and skin and is monitored over time (5 items). If a pain behavior is detected, pain intensity is rated using a 0-10 numerical rating scale.

  2. 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

    The CMAI is a 29-item instrument designed to measure the frequency with which persons with dementia display agitation and other behavioral disturbances. The measure consists of 4 subscales that measure aggressive behavior (hitting, scratching, cursing), physical non-aggressive behavior (pacing, restlessness, disrobing), verbally agitated behavior (complaining, repetitive questions, negativism) and hiding/hoarding. Item frequency is scored on a 1 to 7 scale, with (1) = never, (2) = < once per week, (3) once or twice per week, (4) several times per week, (5) once or twice per day, (6) several times per day, or (7) several times per hour. Total scores range from 29-203.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Florida Department of Health

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Mar 25, 2016
Registry last updated
Mar 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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