Amyloid Beta Protein Clinical Trial
Official title:
Escitalopram Effects on CSF Amyloid Beta Total Concentrations
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.
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.
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