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Agitation in Alzheimer's Disease

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00000179
Enrollment
Unknown
Registered
1999-11-01
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Keywords

Alzheimer's disease, Psychomotor agitation, Behavioral symptoms, Haloperidol, Trazodone, Anti-psychotic agents, Anti-depressant agents

Brief summary

Agitation affects 70 to 90 percent of patients with AD. Signs of agitation include verbal and physical aggressiveness, irritability, wandering, and restlessness. These behaviors often make caring for patients at home very difficult. Trazodone and haldol are two of the most commonly prescribed drugs for agitation in AD patients. Behavior management, a non drug approach, has been effective in reducing signs of agitation. Researchers have yet to compare the effectiveness of drug versus non drug therapy to treat agitation in AD patients and determine which is the best treatment. The Alzheimer's Disease Cooperative Study, with funding from the National Institute on Aging, is conducting an agitation treatment program at 21 sites in 16 States. This study will assess which of the above treatments is most effective.

Interventions

DRUGTrazodone
DRUGHaloperidol

Sponsors

National Institute on Aging (NIA)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026