What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease, such as Selective Serotonin Reuptake Inhibitors (SSRIs) like Escitalopram, can cause side effects including nausea, headache, sleep disturbances, and sexual dysfunction. SSRIs may also exacerbate agitation and carry a risk of increasing suicidal thoughts, particularly in younger populations. Other Alzheimer's treatments, such as cholinesterase inhibitors (e.g., donepezil) and NMDA receptor antagonists (e.g., memantine), can cause gastrointestinal issues, dizziness, and confusion.

What prior FDA approvals exist?

FDA-approved treatments for Alzheimer's Disease primarily include cholinesterase inhibitors (donepezil, rivastigmine, and galantamine) and an NMDA receptor antagonist (memantine). These drugs aim to manage symptoms but do not cure the disease. While escitalopram, an SSRI, is being studied for its potential effects on Alzheimer's biomarkers, it is not currently approved for Alzheimer's treatment. Other investigational drugs in clinical trials include those targeting amyloid plaques (e.g., aducanumab) and tau protein aggregation (e.g., TRx0237).

What other types of research exist?

A promising novel alternative to Escitalopram for Alzheimer's Disease patients is AVN-211, a highly selective 5-HT6 receptor antagonist. AVN-211 has demonstrated significant procognitive and neuroprotective effects in preclinical evaluations, showing improvements in cognition and learning in AD-related behavioral models.

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Selective Serotonin Reuptake Inhibitor

Escitalopram for Depression and Alzheimer's Prevention

Phase 4

Recruiting

Led By Nunzio Pomara, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Only individuals with normal hepatic and renal function including normal creatinine clearance will be included

Medically stable with no significant cerebrovascular, neurological, or systemic disease expected to interfere with the study

Must not have

Treatment with specific medications not permitted

Evidence of clinically relevant or unstable cardiac, pulmonary, endocrine or hematological conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 8

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Escitalopram may cause side effects like nausea, headache, trouble sleeping, fatigue, dry mouth, increased sweating, sexual problems and weight changes. Placebo has no active ingredients but some participants might report symptoms due to their expectations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver and kidney functions are normal.

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I don't have any major health issues that could affect my participation in the study.

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I am 60 years old or older.

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I can hear well and see clearly, with or without glasses.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not currently taking any medications that are excluded from the trial.

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I have no unstable heart, lung, hormone, or blood conditions.

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I do not have mental retardation or serious neurological disorders like Parkinson's.

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I use insulin to manage my diabetes.

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I have a history of brain issues, including tumors, damage, or significant trauma.

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I am currently taking fluoxetine.

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I have had a bad reaction or no improvement with escitalopram.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Scores on Montgomery-Asberg Depression Ration Scale (MADRS)

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Escitalopram (ESC)Active Control1 Intervention

Group II: Placebo (PBO)Placebo Group1 Intervention

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Alzheimer's Disease (AD) include cholinesterase inhibitors (e.g., donepezil, rivastigmine) and NMDA receptor antagonists (e.g., memantine). Cholinesterase inhibitors work by preventing the breakdown of acetylcholine, a neurotransmitter important for learning and memory, thereby improving communication between nerve cells. NMDA receptor antagonists help regulate glutamate activity, which can be harmful in excessive amounts, thus protecting neurons from damage. Additionally, SSRIs like Escitalopram, primarily used to treat depression, are being studied for their potential to normalize AD biomarkers and reduce peripheral inflammation, which may help mitigate some symptoms of AD. These treatments are crucial as they aim to improve cognitive function, manage behavioral symptoms, and potentially slow disease progression, enhancing the quality of life for AD patients.