Specific Interventions for Agitation in Alzheimer's Disease

Status Completed

Clinical Trial Summary

This study is aimed at investigating specific pharmacological interventions in the treatment of the disruptive, agitated behavior associated with Alzheimer's patients. In addition, it is hoped that specific clinical profiles will be found to predict which treatment is most effective for these particular patients.

Clinical Trial Description

Alzheimer's Disease (AD) is the most common cause of dementia, the fourth leading cause of death, and has enormous economic and emotional costs for caregivers of patients. Most of the patients with AD develop disruptive, agitated behaviors at some point during the ailment that are a common catalyst for placement in long-term care settings where they represent more than half of all the residents. Disruptive behaviors create stress for both staff and patients in long-term care settings, reduce patient quality of life because of excess use of physical restraints, and drain the financial resources of the facilities. This study proposes to design specific interventions designed to decrease disruptive, agitated behavior in patients with AD residing in long-term care facilities. This 12-week study will assess the efficacy of two pharmacological agents, an atypical neuroleptic (risperidone) and an anticonvulsant and mood stabilizer (gabapentin) while identifying moderators of differential treatment response to the two drugs. Specifically, this study aims to randomize 130 patients with AD who are manifesting agitated disruptive behavior, into two groups of 65 patients each, with one group receiving risperidone and the other gabapentin. There are two main hypotheses: 1) Patients in both of the treatment groups will manifest different overall group decreases in ratings of disruptive, agitated behavior; and 2) Measurable, clinical characteristics will identify subgroups of subjects with differential treatment response to the two medications. The two variables to be considered as moderators are as follows: a) Patients with higher psychosis ratings will manifest greater responsivity to risperidone compared to gabapentin, and b) Patients with high levels of affective lability will manifest greater responsivity to gabapentin compared to risperidone. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00018291
Study type	Interventional
Source	VA Office of Research and Development
Contact
Status	Completed
Phase	N/A
Start date	January 2001
Completion date	January 2005

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.