Escitalopram To Reduce Amyloid in Older Adults With Depression

What Is This Study About?

Some research suggests a connection between depression and Alzheimer's disease. This Phase 4 trial will evaluate whether treating depression with the drug escitalopram decreases the levels of amyloid, a protein that is associated with the development of Alzheimer's disease. Participants with depression will be randomly assigned to take either an escitalopram pill or a placebo daily for two months. All participants will provide CSF samples at the start and end of the study, which will be used to measure changes in amyloid levels, and will complete a questionnaire, which researchers will use to evaluate any changes in depression.

Do I Qualify To Participate in This Study?

Must have:

• Major depression, based on a clinical evaluation and a Montgomery-sberg Depression Rating Scale score > 18
• Normal cognition, based on neurological testing, including:
  • Mini-Mental State Examination score > 27
  • Clinical Dementia Rating Scale Global score of 0
• Good overall health, based on physical and neurological examinations at study screening
• If taking antidepressants, dosage must be stable for at least three months before starting study
• Fluent in English and able to read at the 6th grade level
• Adequate vision and hearing to complete study tests
• Availability of a reliable study partner to attend screening visit to verify the participants cognitive and daily functioning
• Willing to undergo MRI brain scan, urine drug screen, blood sampling, lumbar puncture, and genetic testing

Must NOT have:

• Serious risk of suicide
• Alcoholism or drug abuse within past two years
• Positive urine drug screen for illicit drugs
• Any condition or implanted device that may make having an MRI brain scan unsafe (e.g., pacemaker, surgical clips, epilepsy)
• History of poor tolerance to, poor response to, or ongoing treatment with escitalopram
• Any serious or unstable medical illness that could interfere with study, including:
  • Cerebrovascular, neurological, liver, kidney, heart, lung, hormone, blood, or systemic disease
  • Insulin-dependent diabetes
  • History of brain tumor or MRI evidence of brain damage (e.g., significant trauma, hydrocephalus, seizures, brain vessel damage)
  • Mental disability or other serious neurological disorder (e.g., Parkinson's disease)
  • Current or past diagnosis of any psychiatric disorder other than major depression (e.g., schizophrenia, bipolar disorder, obsessive compulsive disorder)
• Currently taking medications that could interfere with study, including:
  • Anti-parkinsonian medications (e.g., carbidopa/levodopa, amantadine, bromocriptine, pergolide, selegiline)
  • Chronic use of medications with anticholinergic activity
  • Narcotics, sedatives, or certain medications for treating high blood pressure (e.g., reserpine, clonidine, guanethidine, melatonin)
  • Stimulants (e.g., amphetamines, appetite suppressants, theophylline)
  • Certain antipsychotic or anti-anxiety medications
  • Cholinesterase inhibitors or memantine 
  • Disulfiram, a drug to treat problem drinking
  • Fluoxetine, an antidepressant
  • Continuous use of aspirin or St. John's Wort is acceptable

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 

Where Is This Study Located?

New York
NYU Langone Health New York, NY 10016 Recruiting
Nathan S. Kline Institute for Psychiatric Research Orangeburg, NY 10962 Recruiting Antero Sarreal, MD 845-398-6532 Antero.sarreal@nki.rfmh.org

Who Sponsors This Study?

Lead: NYU Langone Health

Collaborator Sponsor

• National Institute on Aging (NIA)

Source: ClinicalTrials.gov ID: NCT05004987