All studies
Active not recruitingPHASE3INTERVENTIONAL

Escitalopram for Agitation in Alzheimer's Disease

This research study is investigating if a medication called escitalopram can reduce agitation in individuals living with Alzheimer's disease. Agitation can be a challenging symptom of Alzheimer's, affecting both patients and their families. Participants in the study, along with their caregivers, will first try a supportive talking therapy. If this doesn't help, some will receive escitalopram, and others a placebo (a dummy pill), for 12 weeks. The study aims to understand how safe and effective escitalopram is for this condition. It's a 'Phase 3' study, which means it's one of the final steps before a treatment might be considered for wider use.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
JHSPH Center for Clinical Trials
Enrolment target
187
Start
03 Jan 2018
Estimated completion
01 May 2025

What is this study about?

This research study is looking into a common challenge faced by people with Alzheimer's disease: agitation. Agitation can mean restlessness, anxiety, or sometimes aggressive behaviour, and it can be very difficult for both the person with Alzheimer's and their family or carers.

The study aims to find out if a specific medicine, called escitalopram, can safely and effectively reduce these symptoms. Escitalopram is already used for other conditions like depression. In this study, we're carefully testing its use for agitation in Alzheimer's patients. By doing this research, we hope to find new ways to help improve the quality of life for those with Alzheimer's and their caregivers.

It’s important to understand that this is a research study – not a standard treatment. Half of the participants who continue into the medication part of the study will receive the active medicine (escitalopram), while the other half will receive a placebo, which looks identical but contains no active drug. This comparison helps researchers truly understand if the medicine is working or if changes are due to other factors.

Key takeaways

  • The study explores if escitalopram can reduce agitation in Alzheimer's.
  • Participation involves either talking therapy or medication (escitalopram or placebo).
  • A dedicated caregiver is a must for joining this study.
  • The study lasts 12 weeks for those taking medication, with regular check-ups.
  • You can stop participating at any time without affecting your NHS care.

Who may be eligible?

To join this study, people must have been diagnosed with Alzheimer's disease and be experiencing agitation. Their memory and thinking skills will be assessed, but they don't need to be able to fully understand and sign forms themselves, as a caregiver can help with this process. Crucially, a caregiver who spends a good amount of time with them every week and can attend study visits is also required.

There are also some reasons why someone might not be able to join. For example, if they have another brain condition that explains their dementia, such as Parkinson's disease, or if they have severe depression. People living in nursing homes or long-term care facilities are not able to participate. Also, if there's a medical reason why they shouldn't take escitalopram, they won't be able to join. This includes if they've recently taken certain other medicines called MAOIs, or if they're allergic to escitalopram or similar drugs.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Do you have a diagnosis of Alzheimer's disease?
  2. Are you currently experiencing agitation?
  3. Do you have a caregiver who can commit to supporting you in the study?
  4. Are you not currently living in a nursing home or long-term care facility?
  5. Do you have any severe mental health conditions like major depression?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you and your caregiver will first receive support through talking and guidance. If this support doesn't help with agitation after three weeks, you might then be randomly chosen to receive either the study medicine (escitalopram, up to 15 mg per day) or a dummy pill (placebo) for 12 weeks.

Throughout the 12 weeks, you'll have appointments at weeks 3, 6, 9, and 12. Some of these can be in person, while others might be over the phone or video call. There will also be phone calls between these appointments to check in on how you're doing. If the initial talking support does help, you won't take the study medication but will still be checked on remotely for a period. The total duration of participation will depend on whether you receive the medication or respond to the initial support. Your caregiver will be an important part of the process, helping with visits and sharing information.

Potential risks and benefits

Participating in research always carries potential benefits and risks. A potential benefit of this study is that you or your loved one's agitation might improve with the study medication or the initial support. However, it's also possible that there will be no improvement, or that side effects from the medication could occur. As with any medication, escitalopram can have side effects, and these will be carefully monitored by the study team. You have the right to withdraw from the study at any time, for any reason, without affecting your regular medical care.

Locations (29)

  • Banner Sun Health Research Institute
    Verified postcode
    Sun City, United States
  • Biomedical Research Foundation
    Verified postcode
    Little Rock, United States
  • University of Arkansas for Medical Sciences
    Verified postcode
    Little Rock, United States
  • University of California Los Angeles/VA Greater Los Angeles Healthcare System
    Verified postcode
    Los Angeles, United States
  • University of Southern California Keck School of Medicine Memory and Aging Center
    Verified postcode
    Los Angeles, United States
  • Miami Jewish Health Systems
    Verified postcode
    Miami, United States
  • Kansas School of Medicine-Wichita Center for Clinical Research
    Verified postcode
    Wichita, United States
  • Maryland VA Health Care System
    Verified postcode
    Baltimore, United States
  • Johns Hopkins University School of Medicine, Bayview Medical Center
    Verified postcode
    Baltimore, United States
  • Alzheimer Disease Center
    Verified postcode
    Quincy, United States
  • Hackensack Meridian Health
    Verified postcode
    Hackensack, United States
  • Columbia University
    Verified postcode
    New York, United States

Common questions

What is escitalopram?

Escitalopram is a medicine that is commonly used to treat depression and anxiety. In this study, we are researching if it can also help with agitation in people with Alzheimer's disease.

What does 'placebo' mean?

A placebo is a 'dummy' pill that looks just like the study medicine but contains no active drug. It helps researchers know if the real medicine is actually making a difference.

Why is a caregiver needed for this study?

A caregiver is essential as they spend a lot of time with the person with Alzheimer's and can help with visits, give important information, and provide consent if needed.

What happens if the initial talking support helps?

If the initial talking support successfully reduces agitation, you won't need to take the study medication. You will still be followed up on to see how things are going.

How long will the study last for me?

If you go on to take the study medication, this phase will last for 12 weeks, with regular check-ups during that time. The initial support period is 3 weeks.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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