Completed

Effectiveness Comparison of Drug and Non-Drug Therapy for Agitation in Alzheimer's Disease

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Data Collection

Who is being recruted

Aberrant Motor Behavior in Dementia+16

+ Alzheimer Disease

+ Behavior

Over 50 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
See protocol details

Summary

Principal SponsorNational Institute on Aging (NIA)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Agitation is a common issue, affecting up to 90% of Alzheimer's Disease (AD) patients. It includes symptoms like verbal and physical aggression, irritability, wandering, and restlessness, making home care challenging. Two commonly prescribed drugs for agitation in AD are Trazodone and Haldol. There's also a non-drug approach called behavior management, which has shown effectiveness in reducing agitation. However, it's still unknown which method, drug or non-drug, is most effective for treating agitation in AD patients. The Alzheimer's Disease Cooperative Study, funded by the National Institute on Aging, is conducting a treatment program across 21 sites in 16 states to find the best treatment for agitation in AD patients.

Official TitleAgitation in Alzheimer's Disease
NCT00000179
Principal SponsorNational Institute on Aging (NIA)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Aberrant Motor Behavior in DementiaAlzheimer DiseaseBehaviorMental DisordersBehavioral SymptomsBrain DiseasesCentral Nervous System DiseasesDementiaNervous System DiseasesNeurologic ManifestationsPsychomotor AgitationPsychomotor DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodegenerative DiseasesNeurobehavioral ManifestationsNeurocognitive DisordersDyskinesiasTauopathies

Criteria

4 inclusion criteria required to participate
Memory problem consistent with a probable diagnosis of Alzheimer's disease (AD)

Agitation symptoms for at least the past 2 weeks

Patient has caregiver who can participate

Patient lives in the same household as the caregiver

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 16 locations

Suspended

University of California, Los Angeles

Los Angeles, United StatesOpen University of California, Los Angeles in Google Maps
Suspended

University of California, San Diego

San Diego, United States
Suspended

University of Miami

Miami, United States
Suspended

University of South Florida

Tampa, United States
Completed16 Study Centers