Specific Interventions for Agitation in Alzheimer's Disease

NCT00018291 | Completed

• 1 other identifier: AGCG-005-00S
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer's Disease; Dementia

Keywords

Dementia; Agitated Behavior; Behavioral disturbance

Interventions

Risperidone DRUG

Gabapentin DRUG

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of probable AD according to DSM-IV, which show high agreement with NINCDS-ADRDA criteria (McKhann et al., 1984); kappa = 0.81 (Chui et al., in press).
• At least a two-week history of two or more agitated behaviors from the Agitation Screening Inventory (a shortened version of the 24-item Revised Memory and Behavior Problem Checklist) (RMBPC; Teri at al., 1992), occurring at least once weekly, and rated by the caregiver or nursing staff as at least moderately distressing.
• Not planning a change in living situation or placement during the investigational period.
• Stability (of dose and type) of medications for nonexcluded concurrent medical conditions (i.e. thyroid disease, anemia, cardiac disease) for four weeks prior to baseline.
• Ability to ingest oral medications and participate in all scheduled evaluations.
• A sixth grade education or a work history sufficient to exclude mental retardation.
• years of age or older.
• Medically acceptable for experimental drugs as confirmed by physical evaluation and laboratory tests.
• Modified Hachinski Scale score of 4 or less.

You may not qualify if:

• Neurological diagnoses other than AD which affect cognitive function. These include Parkinson?s Disease, tumors, hydrocephalus, history of significant trauma, and seizure disorder).
• A diagnosis of delirium by the Confusion Assessment Method (CAM, Inouye et al., 1990).
• A diagnosis of dementia related to infection with human immunodeficiency virus (HIV) or amnestic disorder, as defined by DSM-IV.
• Known hypersensitivity to risperidone or gabapentin.
• Alcohol or drug abuse within the past year.
• Serious, unstable medical illnesses (e.g., unstable angina, poorly controlled diabetes mellitus, labile hypertension)
• Any medical problem that would cause or exacerbate agitated behaviors (including unstable thyroid dysfunction, electrolyte disturbances, urinary tract infection, fecal impaction, respiratory disease complicated by hypoxia or hypercapnia, etc.)
• Significantly abnormal laboratory findings.
• Significantly abnormal EKG findings.
• Conditions such as blindness, deafness, or other disability that may prevent the patient from participating in the study.
• Current participation in any other investigational drug study or treatment.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

Palo Alto VA Health Care System

Menlo Park, California, 94025, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Psychomotor Agitation; Mental Disorders

Interventions

Risperidone; Gabapentin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED

Study Record Dates

• First Submitted: July 3, 2001
• First Posted: July 5, 2001
• Study Start: January 1, 2001
• Study Completion: January 1, 2005
• Last Updated: January 21, 2009

Record last verified: 2004-12

Locations

US (1)