Escitalopram Effects on CSF Amyloid Beta

Completed · Phase 4 · Has a placebo group

Conditions studied: Amyloid Beta Protein

In brief

Alzheimers disease (AD) is a devastating illness, estimated to affect 5 million patients in the United States alone and projected to increase dramatically over the next decades as the population ages unless preventive measures can be developed. The investigators have preliminary evidence that selective serotonin reuptake inhibitor (SSRI) antidepressants lower the amount of amyloid plaques in the human brain. The interventions now propose to study the effects of an SSRI (escitalopram) on levels of amyloid beta peptide (the major constituent of the plaques) in the cerebrospinal fluid (CSF) of cognitively normal older adults.

Key facts

Study ID

NCT02161458

Run by

University of Pennsylvania

People needed

98

Starts

2014-06-01

Expected to finish

2019-01-01

Last updated by the study team

2020-04-09

Who can join

Age: 60 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 1) Age 60-85 (inclusive), male and female, any race.
• 2) Capacity to give informed consent and follow study procedures.
• 3) English speaking.
• 4) MOCA = 23 or greater

You may not qualify if…

• 1) Known history of relevant severe drug allergy or hypersensitivity (e.g. to Citalopram or Escitalopram)
• 2) Does not speak English
• 3) Cannot give informed consent
• 4) Diagnosis of Major Depression
• 5) Previous history of neurological disorders, such as Parkinson's disease, Alzheimer's disease or traumatic brain injury, cognitive impairment or dementia.
• 6) Diagnosis of a chronic psychiatric illness
• 7) Significant hearing or visual impairment
• 8) Bleeding diathesis
• 9) Clinically significant hepatic, renal, pulmonary, metabolic or endocrine disturbances as indicated by history, which in the opinion of the investigator might pose a potential safety risk to the subject.
• 10) Current clinically significant cardiovascular disease. Clinically significant cardiovascular disease usually includes one or more of the following: cardiac surgery or myocardial infarction within the last 4 weeks; unstable angina; acute decompensated congestive heart failure or class IV heart failure; current significant cardiac arrhythmia or conduction disturbance, particularly those resulting in ventricular fibrillation, or causing syncope or near syncope; uncontrolled high blood pressure; QTc greater than 450msec (by history for subjects with cardiac disease); documented prior stroke.
• 11) Clinically significant abnormalities on EKG. Primary AV block or Right bundle branch block are not necessarily exclusionary.
• 12) History of drug or alcohol abuse within the last year or prior prolonged history of abuse
• 13) Use of an Investigational medicine within the past 30 days 14) Use of Coumadin, Warfarin or other blood thinners within the past 6 months
• 15) Use of antipsychotic medication or antidepressant medication (e.g. MAOIs, SSRIs, SNRIs).
• 16) Use of the following drug/drug classes: Pimozide, Triptans, Tricyclics, Lithium, Tramadol
• 17) Use of over-the-counter supplements such as tryptophan or St. Johns Wort 18) Any other factor that in the investigator's judgment may affect patient safety or compliance (e.g. distance greater than 100 miles from the research institution)

Where it is running

• Washington University — St Louis, Missouri, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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