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Title: Evaluation of lorazepam, pregabalin, and olanzapine in treating agitated behavior in dementia patients who did not respond to standard treatments

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on treating agitated behavior in people with dementia who have not responded well to standard treatments. The research will test three different medications: quetiapine, olanzapine, and lorazepam. These medications belong to a group of drugs called psychotropic drugs, which affect brain function and mental state. The purpose is to determine how well these medications work in controlling agitation symptoms in dementia patients.

During the study, participants will receive either one of the active medications or a placebo. The medications will be given in capsule form and taken by mouth. The treatment period will last for 6 weeks, during which the maximum daily doses will be 50mg for quetiapine, 10mg for olanzapine, or 2mg for lorazepam. To ensure that neither the patients nor the healthcare providers know which treatment is being given, all medications will be placed in identical capsules.

The study will monitor changes in agitated behavior over time using various assessment tools. Healthcare providers will track any side effects that may occur during the treatment period. This research specifically targets nursing home residents who have dementia with agitated behavior and whose doctors have determined they need medication to manage their symptoms.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medication assignment

    You will receive either quetiapine, olanzapine, or lorazepam medication, or a placebo (inactive substance)

    The placebo looks identical to the real medication but contains only microcrystalline cellulose

    The medication or placebo will be taken orally (by mouth)

  2. Step 2

    Treatment monitoring - primary assessment

    Your agitated behavior will be monitored using a special assessment tool called Cohen Mansfield Agitation Inventory (CMAI)

    This assessment helps track changes in agitation levels over time

  3. Step 3

    Treatment monitoring - additional assessments

    Your condition will be evaluated using two additional scales: the Clinical Global Impression of Severity (CGI-S) and Clinical Global Impression of Change (CGI-C)

    The frequency and severity of specific agitated behaviors will be recorded

    Any side effects from the medication will be monitored and documented

  4. Step 4

    Study duration

    The study begins in May 2025

    The study continues until May 2027

    Your participation helps determine if these medications are effective for treating agitation in people with dementia

Who can join the trial?

8 criteria

  • You must be a resident of a nursing home with diagnosed dementia and show signs of agitated behavior (restlessness, aggression, or increased activity)
  • Your treating physician must have already decided to prescribe one of these medications:
    • quetiapine (a medication used to manage behavioral symptoms)
    • olanzapine (a medication used to treat certain mental/mood conditions)
    • lorazepam (a medication used to reduce anxiety and agitation)
    • The decision to use these medications must have been made between you and/or your legal representative and your doctor, independently of this research study
    • You can be either male or female
    • You must be an adult (aged 18 years or older)
    • You must be able to provide consent yourself or have a legal representative who can provide consent on your behalf

Who cannot join the trial?

15 criteria

  • History of severe allergic reactions to any psychiatric medications
  • Presence of other serious mental health conditions besides dementia
  • Severe liver or kidney problems that could affect medication processing
  • Current participation in other clinical trials
  • Inability to comply with study procedures or follow-up visits
  • Use of medications that could interact with the study drugs
  • Uncontrolled high blood pressure or severe heart conditions
  • History of substance abuse within the past 6 months
  • Severe neurological conditions other than dementia
  • Pregnant or breastfeeding women
  • Legal incapacity or limited legal capacity to consent
  • Terminal illness with life expectancy less than 12 months
  • Severe communication difficulties that prevent proper assessment
  • Blood disorders that could affect medication safety
  • Recent major surgery (within past 3 months)
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Investigated drugs

Psychotropic medications are drugs that affect brain function, behavior, and mood. In this trial, these medications are being studied for their effects on agitated behavior in people with dementia when standard recommended treatments haven't worked. These medications work by altering brain chemistry to help manage symptoms like aggression, restlessness, and emotional outbursts that can occur in dementia patients. Non-guideline recommended medications refers to treatments that are not currently included in the standard treatment guidelines for dementia-related agitation. These medications are being evaluated as alternative options for patients who haven't responded well to conventional treatments. Note: The specific medications used in this trial are not explicitly named in the source data, but the trial focuses on testing psychotropic medications that are not currently recommended in treatment guidelines for dementia-related agitation.

What is already known about the treatment

Based on the provided trial data, I'll describe the relevant psychotropic medications commonly used for agitated behavior in dementia: Risperidone - An oral antipsychotic medication available in tablet and liquid form, commonly used to manage severe agitation and aggression in dementia patients. This medication works by blocking specific dopamine and serotonin receptors in the brain, helping to reduce aggressive and agitated behaviors. It belongs to the class of second-generation (atypical) antipsychotics and is one of the few medications with substantial evidence for treating behavioral symptoms in dementia. Quetiapine - An atypical antipsychotic medication administered orally as tablets, used off-label in dementia-related agitation when other treatments have failed. It acts on multiple neurotransmitter receptors in the brain, particularly dopamine and serotonin, to help control agitated behavior and psychological symptoms. This medication is known for having a relatively favorable side effect profile compared to other antipsychotics used in elderly patients. Haloperidol - A first-generation antipsychotic medication available in oral and injectable forms, used for severe agitation in dementia when rapid control is needed. It works primarily by blocking dopamine receptors in the brain, helping to reduce severe behavioral disturbances and agitation. This medication is typically reserved for short-term use in cases where other treatments have proven ineffective.

Investigated diseases

  • Agitated Behavior

    A state characterized by excessive psychomotor activity often accompanied by irritability, aggression, and emotional lability. It manifests as restlessness, pacing, verbal outbursts, or physical aggression. The condition can vary in intensity from mild fidgeting to severe physical agitation. It frequently occurs as part of other medical or psychiatric conditions.

  • Dementia

    A group of symptoms affecting memory, thinking, and social abilities severely enough to interfere with daily life. The condition is characterized by a decline in cognitive function, including memory loss and difficulties with reasoning, language, and problem-solving. Dementia typically develops gradually and progresses over time. The condition affects behavior, feelings, and relationships.

Trial detailsLast updated 7 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2024-510601-29-00Estimated enrolment100 patientsSponsorAmsterdam UMC Stichting

sourced from the EU Clinical Trials Register and site verification

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