Escitalopram Effects on CSF Amyloid Beta
Condition: Amyloid Beta Protein
MeSH terms: Amyloidosis
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      The investigators will measure CSF Amyloid Beta levels before and after two weeks or eight
      weeks of treatment with escitalopram using a double blind placebo-controlled study design
      with approximately 30 cognitively normal participants, age 60-85, with a MOCA of 23 or
      higher. They will be recruited from the community. Participants will be randomized
      (approximately 30 per group).

      Participants in the 2 week arm will have 3 study visits:

        1. Screening Visit: Consent and screening procedures will be complete. Participants will be
           randomized 1:1 to receive escitalopram or placebo.

        2. Study Visit 1: This visit will take approximately 45 minutes - 1 hour; participants will
           have a lumbar puncture (LP) in order to obtain cerebrospinal fluid (CSF), a blood draw,
           and will receive study medication.

        3. Study Visit 2: This visit will take approximately 45 minutes - 1 hour; participants will
           have a lumbar puncture (LP) in order to obtain cerebrospinal fluid (CSF), a blood draw,
           will receive taper-down study medication, and will complete an end-of-study
           questionnaire.

      Participants in the 8-week arm(s) will have 4 study visits:

        1. Screening Visit: Consent and screening procedures will be complete. Participants will be
           randomized 1:1 to receive escitalopram or placebo.

        2. Study Visit 1: This visit will take approximately 45 minutes - 1 hour; participants will
           have a lumbar puncture (LP) in order to obtain cerebrospinal fluid (CSF), a blood draw,
           and will receive 4 weeks of study medication.

        3. Study Visit 2: Researchers will check in with participants and participants will receive
           another 4 weeks of study medication.

        4. Study Visit 3:This visit will take approximately 45 minutes - 1 hour; participants will
           have a lumbar puncture (LP) in order to obtain cerebrospinal fluid (CSF), a blood draw,
           will receive taper-down study medication, and will complete an end-of-study
           questionnaire.

      The current proposal will test whether clinically relevant doses of an SSRI reduce CSF levels
      of Amyloid Beta in healthy older human participants. The investigators hypothesize that
      compared to placebo, participants receiving escitalopram will show significantly lower
      Amyloid Beta levels in the second CSF sample.
    

Intervention name(s): Escitalopram 20mg for 2 weeks; Escitalopram 20mg for 8 weeks; Escitalopram 30mg for 8 weeks; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: Escitalopram; Amyloid Beta; Cerebrospinal Fluid