Behavioral Expressions in Alzheimer's Disease

NCT ID: NCT02719834

Last Updated: 2018-03-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2018-02-28

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

Conditions

Alzheimer's Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Acetaminophen, then placebo

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

Acetaminophen

Intervention Type: 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.

Placebo

Intervention Type: 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.

Placebo, then acetaminophen

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

Acetaminophen

Intervention Type: 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.

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Other Intervention Names

Tylenol; Methycellulose

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Florida Department of Health

OTHER_GOV

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ann Horgas-Marsiske, RN PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

Oak Hammock Continuing Care Retirement Faculty

Gainesville, Florida, United States

Countries

United States

Other Identifiers

6AZ10

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB201600020

Identifier Type: -

Identifier Source: org_study_id