Behavioral Expressions in Alzheimer's Disease

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02719834
• Other study ID #: IRB201600020
• Secondary ID: 6AZ10
• Status: Completed
• Phase: N/A
• First received: March 21, 2016
• Last updated: March 1, 2018
• Start date: April 2016
• Est. completion date: February 2018

Study information

• Verified date: March 2018
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: February 2018
• Est. primary completion date: February 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Oak Hammock Continuing Care Retirement Faculty	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Florida Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Change from baseline, weeks 2, 4, 6 and 8
Primary	Cohen-Mansfield Agitation Inventory (CMAI) will be used for changes between the groups at 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.	Change from baseline, weeks 2, 4, 6 and 8