60 Participants Needed

Escitalopram for Depression and Alzheimer's Prevention

Recruiting at 1 trial location
AS
CR
Overseen ByChelsea Reichert Plaska, PhD
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether treating depression with the antidepressant escitalopram (also known as Lexapro or Cipralex) can help prevent Alzheimer's disease by examining biological markers related to Alzheimer's. Participants will receive either escitalopram or a placebo to determine if reducing depression might also affect these markers. The trial seeks individuals aged 60 or older who have been diagnosed with major depressive disorder and do not have memory or cognitive issues. Participants should not have significant neurological conditions or a history of severe substance abuse. The goal is to understand if managing depression can lower the risk of developing Alzheimer's disease. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand how escitalopram benefits more patients.

Do I need to stop taking my current medications to join the trial?

You may need to stop taking certain medications to join the trial. If you are on antidepressants like fluoxetine, you will need a washout period (time without taking the medication). Some medications, like continuous aspirin or NSAIDs, must be temporarily stopped before certain procedures. If you are on stable doses of prescribed psychoactive medications, you may be able to continue them.

What is the safety track record for escitalopram?

Research has shown that escitalopram, an FDA-approved medication for major depression, is usually well-tolerated. Studies have found that it can lower levels of amyloid-β (Aβ), a protein linked to Alzheimer's disease, in the brain and spinal fluid. This suggests potential benefits beyond treating depression.

While escitalopram is generally safe, some reports mention side effects. One study linked it to a faster decline in thinking skills compared to another antidepressant, sertraline. This indicates that while escitalopram effectively treats depression, its impact on mental function should be considered, especially with long-term use.

Overall, escitalopram is widely used and considered safe for treating depression. However, discussing any concerns or possible side effects with a healthcare provider is always important.12345

Why are researchers enthusiastic about this study treatment?

Escitalopram is unique because it is being explored not just as a treatment for depression, which is its typical use, but also for its potential to prevent Alzheimer's disease. Unlike most treatments that primarily focus on managing symptoms of depression, escitalopram might offer dual benefits by also targeting the mechanisms involved in Alzheimer's prevention. Researchers are excited about this possibility because it could represent a significant advancement in treating two conditions with one medication, potentially simplifying therapy and improving patient outcomes.

What is the effectiveness track record for escitalopram in treating depression and potentially preventing Alzheimer's?

Research shows that escitalopram, a type of antidepressant, can effectively reduce symptoms of depression. A review of several studies found that escitalopram significantly helped reduce depression in people with Alzheimer's disease. Other studies also found that escitalopram lowered levels of a protein linked to Alzheimer's in both mice and humans. In this trial, participants will receive either escitalopram or a placebo to evaluate its effects on depression and Alzheimer's prevention. While escitalopram has shown promise in treating depression and Alzheimer's-related issues, some research suggests that older adults taking these antidepressants might have a higher risk of developing dementia compared to those who receive talk therapy. Overall, escitalopram has been effective for depression and may also impact Alzheimer's-related markers.12367

Who Is on the Research Team?

Nunzio Pomara, MD | NYU Langone Health

Nunzio Pomara

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for individuals aged 60+ with major depressive disorder and no cognitive impairment, as indicated by specific mental state and dementia rating scales. Participants must be medically stable, fluent in English, willing to undergo various tests including MRI and lumbar puncture, and not have a significant history of neurological disorders or substance abuse.

Inclusion Criteria

Have results of a physical examination, neurological examination, vitals, and EKG within normal limits at screening
I can read and understand English at a 6th grade level or higher.
Clinical Dementia Rating Scale (CDR) Global of 0
See 9 more

Exclusion Criteria

I am not currently taking any medications that are excluded from the trial.
I have no unstable heart, lung, hormone, or blood conditions.
I do not have mental retardation or serious neurological disorders like Parkinson's.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the SSRI antidepressant escitalopram or placebo to treat depressive symptoms

8 weeks
Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Escitalopram Oxalate
  • Placebo
Trial Overview The study compares the antidepressant escitalopram oxalate against a placebo to see if treating depression affects Alzheimer's disease biomarkers. It aims to understand whether improving depression can normalize biological factors linked to Alzheimer's risk.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Escitalopram (ESC)Active Control1 Intervention
Group II: Placebo (PBO)Placebo Group1 Intervention

Escitalopram Oxalate is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Lexapro for:
🇪🇺
Approved in European Union as Cipralex for:
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Approved in Canada as Cipralex for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Citations

Escitalopram for agitation in Alzheimer's Disease (S-CitAD)Racemic citalopram was effective, with 40% of citalopram-treated participants experiencing clinical improvement vs. 26% on placebo.
A systematic review and meta-analysis on the efficacy ...SSRIs attenuated depressive symptoms in patients with AD (0.905 SMD, 95%CI, 0.689 to 1.121, p < 0.000). At individual SSRI level, escitalopram, ...
Antidepressant use and cognitive decline in patients with ...However, older adults with depression receiving SSRIs/SNRIs were associated with an increased risk of dementia compared to psychotherapy [2].
Effect of escitalopram on Aβ levels and plaque load in an ...Escitalopram significantly reduced Aβ in mice, similar to previous findings in humans treated with acute dosing of an SSRI.
Does Escitalopram Prevent Alzheimer-Related Agitation?At 12 weeks, the proportion of patients whose agitation improved did not differ significantly between the groups (≈30% in each group), nor did ...
Comparative efficacy and safety of antidepressant therapy ...The results of the CitAD trial revealed that 30 mg of citalopram daily improved BPSD symptoms and agitation scores in non-depressed patients ...
Could antidepressant drugs aid Alzheimer disease ...Treatment with the selective serotonin reuptake inhibitor (SSRI) escitalopram can reduce amyloid-β (Aβ) levels in cerebrospinal fluid (CSF) and brain tissue.
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