Escitalopram Effects on CSF Amyloid Beta
Condition: Amyloid Beta Protein
MeSH terms: Amyloidosis
Intervention: Escitalopram 20mg for 2 weeks; Escitalopram 20mg for 8 weeks; Escitalopram 30mg for 8 weeks; Placebo
Intervention description: 30 cognitively normal adults aged 60-85 will receive escitalopram 20 mg for 2 weeks; amyloid beta levels in the CSF will be measured at baseline (before drug administration) and following the full study drug (i.e., active drug) administration.; 30 cognitively normal adults aged 60-85 will receive escitalopram 20 mg for 8 weeks; amyloid beta levels in the CSF will be measured at baseline (before drug administration) and following the full study drug (i.e., active drug) administration.; 30 cognitively normal adults aged 60-85 will receive escitalopram 30 mg for 8 weeks; amyloid beta levels in the CSF will be measured at baseline (before drug administration) and following the full study drug (i.e., active drug) administration.; Additionally, 30 cognitively normal adults aged 60-85 will receive a placebo; amyloid beta levels in the CSF will be measured at baseline (before drug administration) and following the full study drug (i.e., placebo) administration.
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 98.0
Sex: All
Minimum age: 60 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Escitalopram; Amyloid Beta; Cerebrospinal Fluid

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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)