Alzheimer's DiseaseNCT00018291
Specific Interventions for Agitation in Alzheimer's Disease
A study testing Risperidone and Gabapentin in people with Alzheimer's Disease and Dementia, run by US Department of Veterans Affairs at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Disease, Dementia
- What is being tested?
- Risperidone and Gabapentin
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jan 2001to Jan 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 50 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.
Who cannot join
- 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)
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- 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.)
- Any psychotropic medications or other medications which may cause or exacerbate agitated behavior. Patients taking these medications may participate in the study if the drugs can be successfully discontinued during the washout period and the remainder of the study, and if after discontinuation they still meet inclusion criteria for the investigation. Excluded medications include: antipsychotics; antidepressants; anxiolytics; CNS stimulants; anti convulsants; and sedative hypnotics.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Palo Alto VA Health Care System
Menlo Park, California, 94025
About this study
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.
Read the detailed 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.
- Conditions
- Alzheimer's Disease, Dementia
- Being tested
- Risperidone, Gabapentin
- Keywords
- Dementia, Agitated Behavior, Behavioral disturbance
- Medical subject headings
- Alzheimer Disease, Dementia, Psychomotor Agitation, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
GabapentinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2001 (estimated)
- Study startJan 2001
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00018291
- Sponsor's protocol ID
- AGCG-005-00S
- Status last verified
- Dec 2004
- First submitted
- 3 Jul 2001
- Last updated
- 21 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specific Interventions for Agitation in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00018291
- Acronym / sponsor ID
- AGCG-005-00S
- Conditions
- Alzheimer's Disease, Dementia
- Keywords
- Dementia, Agitated Behavior, Behavioral disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jan 2001
- Study completion
- Jan 2005
- First posted
- 5 Jul 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risperidone | Drug | – |
| Gabapentin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risperidone and Gabapentin in people with Alzheimer's Disease and Dementia, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2009.