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Behavioral Expressions in Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02719834
Recruitment Status : Completed
First Posted : March 25, 2016
Last Update Posted : March 2, 2018
Sponsor:
Collaborator:
Florida Department of Health
Information provided by (Responsible Party):
University of Florida

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).

Condition or disease Intervention/treatment
Alzheimer's Disease Drug: Acetaminophen Other: Placebo

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

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Study Type : Observational
Actual Enrollment : 4 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Analgesic Trial to Reduce Pain and Behavior Disruptions in Nursing Home Residents With Alzheimer's Disease
Actual Study Start Date : April 2016
Actual Primary Completion Date : February 9, 2017
Actual Study Completion Date : February 2018


Group/Cohort Intervention/treatment
Acetaminophen, then placebo
Participants in this group will receive acetaminophen for the first four weeks, then placebo for the next four weeks.
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 Name: Tylenol

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.
Other Name: Methycellulose

Placebo, then acetaminophen
Participants in this group will receive placebo for the first four weeks, then acetaminophen for the next four weeks.
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 Name: Tylenol

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.
Other Name: Methycellulose




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We will recruit study participants from senior communities in the Gainesville area.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02719834


Locations
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United States, Florida
Oak Hammock Continuing Care Retirement Faculty
Gainesville, Florida, United States, 32607
Sponsors and Collaborators
University of Florida
Florida Department of Health
Investigators
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Principal Investigator: Ann Horgas-Marsiske, RN PhD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02719834    
Other Study ID Numbers: IRB201600020
6AZ10 ( Other Grant/Funding Number: Florida Department of Health )
First Posted: March 25, 2016    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics