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 will test if treating depression with the antidepressant escitalopram can affect biological markers related to Alzheimer's disease. It targets people with major depressive disorder to see if reducing their depression can also lower their risk of developing Alzheimer's. The study compares escitalopram to understand its effects on these markers. Escitalopram is commonly used to treat major depressive disorder.

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.

Is escitalopram safe for humans?

Escitalopram, also known as Lexapro or Cipralex, is generally considered safe for humans, but like many medications, it can have side effects. Some studies have looked at its use in Alzheimer's disease and depression, and while it may be safer than some antipsychotics, there are concerns about potential heart-related side effects, similar to those seen with citalopram.12345

How is the drug escitalopram unique for treating depression and preventing Alzheimer's?

Escitalopram is unique because it is being studied not only for treating depression but also for potentially preventing dementia in patients with depression and cognitive issues related to chronic brain ischemia (reduced blood flow to the brain). Unlike other treatments, it is being explored for its dual role in addressing both mood and cognitive symptoms in Alzheimer's disease.12367

What data supports the effectiveness of the drug Escitalopram for preventing Alzheimer's in patients with depression?

Research suggests that selective serotonin reuptake inhibitors (SSRIs), like escitalopram, may improve cognitive performance in Alzheimer's disease, although it's unclear if this is due to direct effects on cognition or mood stabilization.24689

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:
  • Major depressive disorder
  • Generalized anxiety disorder
🇪🇺
Approved in European Union as Cipralex for:
  • Major depressive episodes
  • Generalized anxiety disorder
  • Social anxiety disorder
  • Panic disorder with or without agoraphobia
  • Obsessive-compulsive disorder
🇨🇦
Approved in Canada as Cipralex for:
  • Major depressive disorder
  • Generalized anxiety disorder
  • Social anxiety disorder

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+

Published Research Related to This Trial

Sertraline, a selective serotonin reuptake inhibitor, is one of the most studied antidepressants for treating depression in Alzheimer's Disease, but traditional antidepressants often show only modest benefits due to the unique causes of depression in these patients.
Current research is exploring new drug classes, including those targeting glutamate transmission and the NMDA antagonist ketamine, as potential treatments, highlighting the need for more effective and multimodal approaches to manage depression in Alzheimer's patients.
Pharmacotherapy for the treatment of depression in patients with alzheimer's disease: a treatment-resistant depressive disorder.Lozupone, M., La Montagna, M., D'Urso, F., et al.[2022]
The DIADS-2 study is a well-structured, randomized, placebo-controlled trial designed to evaluate the efficacy and safety of sertraline, a selective serotonin reuptake inhibitor, for treating depression in Alzheimer’s disease, addressing previous research limitations like small sample sizes and short follow-up periods.
This study includes comprehensive measures of patient and caregiver outcomes, structured psychosocial therapy for caregivers, and ongoing diagnostic evaluations, aiming to provide a thorough understanding of depression in Alzheimer’s patients and its treatment effects.
Design of Depression in Alzheimer's Disease Study-2.Martin, BK., Frangakis, CE., Rosenberg, PB., et al.[2022]
Preclinical studies suggest that SSRIs may enhance cognitive function in Alzheimer's disease by acting on the hippocampus, potentially stimulating neurogenesis and reducing amyloid plaque formation, but clinical trials have not consistently measured cognitive outcomes separately from mood stabilization.
Current evidence does not support SSRIs as effective cognition enhancers or disease modifiers in Alzheimer's, highlighting the need for better-designed clinical trials that assess multiple outcome variables, including mood, behavior, and neurochemistry.
Potential cognitive enhancing and disease modification effects of SSRIs for Alzheimer's disease.Chow, TW., Pollock, BG., Milgram, NW.[2021]

Citations

Pharmacotherapy for the treatment of depression in patients with alzheimer's disease: a treatment-resistant depressive disorder. [2022]
Design of Depression in Alzheimer's Disease Study-2. [2022]
Potential cognitive enhancing and disease modification effects of SSRIs for Alzheimer's disease. [2021]
4.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Comparison of different doses of escitalopram in the prevention of dementia in patients with depression and moderate cognitive dysfunction associated with chronic brain ischemia]. [2022]
Efficacy and Safety of Citalopram Compared to Atypical Antipsychotics on Agitation in Nursing Home Residents With Alzheimer Dementia. [2018]
Citalopram for agitation in Alzheimer's disease: design and methods. [2022]
Escitalopram versus risperidone for the treatment of behavioral and psychotic symptoms associated with Alzheimer's disease: a randomized double-blind pilot study. [2022]
When and How to Treat Agitation in Alzheimer's Disease Dementia With Citalopram and Escitalopram. [2022]
Escitalopram for agitation in Alzheimer's disease (S-CitAD): Methods and design of an investigator-initiated, randomized, controlled, multicenter clinical trial. [2022]
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