Escitalopram for Depression and Alzheimer's Prevention
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: NYU Langone Health
Must not be taking: Fluoxetine, Anti-Parkinsonian, Cholinesterase inhibitors, others
Disqualifiers: Brain tumor, Alcoholism, Schizophrenia, others
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
45678How 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.
34679Eligibility Criteria
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
+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.
+10 more
Trial Timeline
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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Nathan S. Kline Institute for Psychiatric ResearchOrangeburg, NY
NYU Langone HealthNew York, NY
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Who Is Running the Clinical Trial?
NYU Langone HealthLead Sponsor
National Institute on Aging (NIA)Collaborator
References
Design of Depression in Alzheimer's Disease Study-2. [2022]Research on the efficacy of antidepressant therapy for depressive symptoms in Alzheimer disease has been hampered by lack of systematic diagnosis, small sample sizes, and short-term follow up. To address these issues, the authors present the design of the Depression in Alzheimer's Disease Study-2 (DIADS-2), a randomized, placebo-controlled multicenter trial to evaluate the efficacy and safety of the selective serotonin reuptake inhibitor sertraline for the treatment of depression in people with Alzheimer disease.
Potential cognitive enhancing and disease modification effects of SSRIs for Alzheimer's disease. [2021]Selective serotonin reuptake inhibitors (SSRIs) have increased cognitive performance in some clinical studies of Alzheimer's disease (AD), but it is has been difficult to dissociate whether this is due to direct effects on cognition (neurochemical or disease-modifying) or a secondary effect of mood stabilization. We performed a systematic review for preclinical and human clinical trial evidence to support the use of SSRIs specifically for the management of cognitive decline in AD.
Pharmacotherapy for the treatment of depression in patients with alzheimer's disease: a treatment-resistant depressive disorder. [2022]Pharmacotherapy for the treatment of depressive disorders in Alzheimer's Disease (AD) represents a clinical challenge. pharmacological options are often attempted after a period of watchful waiting (8-12 weeks). monoaminergic antidepressant drugs have shown only modest or null clinical benefits, maybe because the etiology of depressive symptoms in ad patients is fundamentally different from that of nondemented subjects.
[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]to compare different doses of escitalopram (cipralex) in the prevention of dementia in patients with depression and moderate cognitive dysfunction associated with chronic brain ischemia.
Efficacy and Safety of Citalopram Compared to Atypical Antipsychotics on Agitation in Nursing Home Residents With Alzheimer Dementia. [2018]To assess efficacy and safety of citalopram compared to quetiapine and olanzapine for the treatment of agitation in patients with Alzheimer disease (AD).
Citalopram for agitation in Alzheimer's disease: design and methods. [2022]Agitation is one of the most common neuropsychiatric symptoms of Alzheimer's disease (AD), and is associated with serious adverse consequences for patients and caregivers. Evidence-supported treatment options for agitation are limited. The citalopram for agitation in Alzheimer's disease (CitAD) study was designed to evaluate the potential of citalopram to ameliorate these symptoms.
Escitalopram versus risperidone for the treatment of behavioral and psychotic symptoms associated with Alzheimer's disease: a randomized double-blind pilot study. [2022]Antipsychotics are frequently used to treat psychosis, aggression and agitation in patients with Alzheimer's disease (AD), but safety warnings abound. Escitalopram was investigated since citalopram has demonstrated some effectiveness in AD. We compared escitalopram and risperidone for psychotic symptoms and agitation associated with AD.
When and How to Treat Agitation in Alzheimer's Disease Dementia With Citalopram and Escitalopram. [2022]Agitation is a common neuropsychiatric symptom (NPS) in the early and middle stages of Alzheimer's disease (AD) dementia, which is difficult to treat and causes much distress. The U.S. Food and Drug Administration (U.S. FDA) issued black box warnings against the use of antipsychotics in dementia in 2005 and 2008 due to the increased risk of morbidity and mortality, resulting in the reduction in antipsychotic use for treating dementia-related NPS and spurring the quest for safer and more effective pharmacological options. The data favoring the use of citalopram for treating agitation in AD dementia is particularly compelling, and this may be a class effect for all selective serotonin reuptake inhibitors. However, concerns about the cardiac side-effects of citalopram have limited its widespread use for this indication. In this article, available efficacy and safety data for the use of citalopram and escitalopram in treating agitation in AD dementia is reviewed, using a composite case to illustrate key points. Practical recommendations are made to facilitate the use of these medications in routine clinical practice, risk mitigation strategies are discussed and salient issues for future clinical research are emphasized.
Escitalopram for agitation in Alzheimer's disease (S-CitAD): Methods and design of an investigator-initiated, randomized, controlled, multicenter clinical trial. [2022]Alzheimer's disease (AD) is a disabling, common cause of dementia, and agitation is one of the most common and distressing symptoms for patients with AD. Escitalopram for agitation in Alzheimer's disease (S-CitAD) tests a novel, clinically derived therapeutic approach to treat agitation in patients with AD.