NCT00012857

Brief Summary

Dementia illness often co-exists with painful medical conditions associated with aging (e.g., degenerative joint disease, osteoarthritis, skin ulcers, back pain, headaches, cancer, or angina). While the standard practice is pain assessment for all patients, the elderly with dementia have special needs for assessment, management, and evaluation. When they are unable to verbalize pain, objective measurement of their discomfort are possible manifestations of pain. No research relates systemic pain treatment with reduction of negative problematic behaviors in patient dementia.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

March 1, 2001

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2001

Completed
Last Updated

April 7, 2015

Status Verified

February 1, 2007

First QC Date

March 14, 2001

Last Update Submit

April 6, 2015

Conditions

DementiaAlzheimer Disease, PainBehavior, Agitation

Study Arms (1)

Arm 1

OTHER
Drug: acetaminophen 650 mg qid and placebo qid PRN. The other arm was placebo qid and acetaminophen 650 mg qid PRN

Interventions

acetaminophen 650 mg qid and placebo qid PRN. The other arm was placebo qid and acetaminophen 650 mg qid PRNDRUG
Arm 1

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must be: 55 years old and older, nursing home residents, a diagnosed painful that would respond to tylenol, documented agitated behavior, a dementia diagnosis or a functional impairment severe enough to rate a 7 on the Global Deterioration Scale, be unable to report pain. Patients must have been residents in the nursing home for at least 1 month with a plan to stay at least 2 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

MeSH Terms

Conditions

DementiaAlzheimer DiseasePainBehaviorPsychomotor Agitation

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDyskinesiasPsychomotor DisordersNeurobehavioral ManifestationsAberrant Motor Behavior in DementiaBehavioral Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Marilyn K. Douglas, DNSc RN FAAN

    VA Palo Alto Health Care System, Palo Alto, CA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2001

First Posted

March 16, 2001

Study Completion

March 1, 2001

Last Updated

April 7, 2015

Record last verified: 2007-02

Locations

US(1)