Alzheimer's DiseasePhase 4NCT00260624
Escitalopram Treatment of Patients With Agitated Dementia
A Phase 4 study testing Escitalopram (Lexapro) in people with Alzheimer's Disease and Psychomotor Agitation, run by University of Rochester at 3 sites in United States.
Trial summary
The purpose of this study is to determine the safety and efficacy of escitalopram (Lexapro) using 10 or 20 mg daily in patients with Alzheimer's disease who are also experiencing agitation. Read more about this study
- Who is it for?
- Ages 61 years and older
- Conditions the study is for
- Alzheimer's Disease, Psychomotor Agitation
- What is being tested?
- Escitalopram (Lexapro)
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2003to Dec 2006
- Phase
- Phase 4
- 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 61 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dementia of Alzheimer's type with behavioral disturbance
- Mild to severe cognitive impairment
- Age over 60
- Medically stable
- Agitation present both at screening and baseline
- Agitation not responsive to simple nonpharmacologic interventions and lasting at least 2 weeks prior to enrollment.
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- Available Health Care Proxy or other legal representative to give informed consent, and patient assent.
- No planned change in environment for duration of study
- At least one reliable caregiver
Who cannot join
- Any intercurrent medical problem that could explain the agitation
- History of major depression or bipolar preceding the onset of dementia
- Other major psychiatric illness preceding the onset of dementia or mental retardation
- Other dementias
- History of alcohol abuse or dependence in the last 2 years
- Delirium (or history of delirium in the last 8 weeks)
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- Treatment with other psychotropic drugs except those permitted in the protocol. Patients already treated for agitation with psychotropic medication must be able to successfully discontinue it and tolerate a washout period of no less than 1 week.
- Treatment with non-psychotropic, centrally active drugs believed to contribute to patient's agitation.
- Severe psychiatric symptoms requiring psychiatric hospitalization or suicidal, homicidal potential.
- History of intolerance to citalopram
- Noncompliance with oral medication or inability to take oral medication
- Modified Hachinski score of 4 or greater
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Fairport Baptist Home
Fairport, New York, 14450
The Highlands at Brighton
Rochester, New York, 14618
University of Rochester
Rochester, New York, 14642
About this study
Official title: Escitalopram in the Treatment of Patients With Agitated Dementia
The purpose of this study is to determine the safety and efficacy of escitalopram (Lexapro) using 10 or 20 mg daily in patients with Alzheimer's disease who are also experiencing agitation.
Read the detailed description
This study is designed for men and women over 60 who have an established diagnosis of mild to severe Alzheimer's disease and who also present behaviors of agitation such as restlessness, physical aggression, yelling and socially inappropriate interactions. While nonpharmacologic interventions are preferable, many times they are not effective alone. Each consented subject will be enrolled in a 12 week study with escitalopram, 10 or 20 mg per day. Each subject will be evaluated using rating scales designed for symptoms of Alzheimer's and agitated behavior. Each subject will also undergo physical and neurological examinations, laboratory tests and monitoring of side effects of escitalopram.
- Conditions
- Alzheimer's Disease, Psychomotor Agitation
- Being tested
- Escitalopram (Lexapro)
- Keywords
- agitation, dementia, Alzheimer's Disease
- Medical subject headings
- Alzheimer Disease, Psychomotor Agitation, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Escitalopram (Lexapro)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Agitation factor on the Neurobehavioral Rating Scale (NBRS)
Secondary outcomes (4)
Total NBRS scores
Cohen-Mansfield Agitation Inventory
Neuropsychiatric Inventory
Global Clinical Impression of Change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startFeb 2003
- Primary completionDec 2006
- Study completionDec 2006
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.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Investigators
- Adrian Leibovici MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260624
- Sponsor's protocol ID
- LXP MD 43
- Status last verified
- Feb 2012
- First submitted
- 29 Nov 2005
- Last updated
- 24 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Escitalopram in the Treatment of Patients With Agitated Dementia
- ClinicalTrials.gov ID
- NCT00260624
- Acronym / sponsor ID
- LXP MD 43
- Conditions
- Alzheimer's Disease, Psychomotor Agitation
- Keywords
- agitation, dementia, Alzheimer's Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Feb 2003
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 1 Dec 2005 (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.
The purpose of this study is to determine the safety and efficacy of escitalopram (Lexapro) using 10 or 20 mg daily in patients with Alzheimer's disease who are also experiencing agitation.
Detailed description
This study is designed for men and women over 60 who have an established diagnosis of mild to severe Alzheimer's disease and who also present behaviors of agitation such as restlessness, physical aggression, yelling and socially inappropriate interactions. While nonpharmacologic interventions are preferable, many times they are not effective alone. Each consented subject will be enrolled in a 12 week study with escitalopram, 10 or 20 mg per day. Each subject will be evaluated using rating scales designed for symptoms of Alzheimer's and agitated behavior. Each subject will also undergo physical and neurological examinations, laboratory tests and monitoring of side effects of escitalopram.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 61 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Dementia of Alzheimer's type with behavioral disturbance
- Mild to severe cognitive impairment
- Age over 60
- Medically stable
- Agitation present both at screening and baseline
Key exclusion criteria (12 listed)
- Any intercurrent medical problem that could explain the agitation
- History of major depression or bipolar preceding the onset of dementia
- Other major psychiatric illness preceding the onset of dementia or mental retardation
- Other dementias
- History of alcohol abuse or dependence in the last 2 years
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 |
|---|---|---|
| Escitalopram (Lexapro) | Drug | – |
Primary outcome
Agitation factor on the Neurobehavioral Rating Scale (NBRS)
4 secondary outcomes
Total NBRS scores
Cohen-Mansfield Agitation Inventory
Neuropsychiatric Inventory
Global Clinical Impression of Change
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 24 Feb 2012.
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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.
Adrian Leibovici MD principal investigator
University of Rochester
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Escitalopram (Lexapro) in people with Alzheimer's Disease and Psychomotor Agitation, run by University of Rochester at 3 sites 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 24 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Agitation factor on the Neurobehavioral Rating Scale (NBRS). It is what the study was designed to measure, not a finding.
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 24 Feb 2012.