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Escitalopram Effects on CSF Amyloid Beta

Information source: University of Pennsylvania
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Amyloid Beta Protein

Intervention: Escitalopram or Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Pennsylvania

Official(s) and/or principal investigator(s):
Yvette Sheline, M.D., Principal Investigator, Affiliation: University of Pennsylvania

Overall contact:
Yvette Sheline, M.D., Phone: 215-573-0082, Email: sheline@mail.med.upenn.edu

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. The investigators will measure CSF Amyloid Beta levels before and after two weeks of treatment with escitalopram using a double blind placebo-controlled study design with approximately 30 cognitively normal participants, age 65-85, with a Clinical Dementia Rating scale, [CDR] = 0. They will be recruited from the community. Participants will be randomized (approximately 15 per group). Participants will have three office visits: the first visit will be for screening and consent and participants will be randomized 1: 1 to receive escitalopram or placebo for two weeks; the second and the third visits will be for lumbar puncture (LP) and CSF analysis. Each LP visit will take about 2 hours. The second LP will occur two weeks after the first LP. At each LP visit, approximately 1½ tablespoons of blood and 4 teaspoons of CSF will be obtained. Participants randomized to escitalopram will take 10 mg escitalopram for 5 days, then take 20 mg escitalopram for the remainder of the two week exposure period, and then taper down to 10mg for 3 days. 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.

Clinical Details

Official title: Escitalopram Effects on CSF Amyloid Beta Total Concentrations

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Primary outcome: Amyloid Beta Levels in CSF

Eligibility

Minimum age: 65 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 1) Age 65-85 (inclusive), male and female, any race.

- 2) Capacity to give informed consent and follow study procedures.

- 3) English speaking.

- 4) Clinical dementia rating (CDR) of 0 (Cognitively normal)

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)

Locations and Contacts

Yvette Sheline, M.D., Phone: 215-573-0082, Email: sheline@mail.med.upenn.edu

Washington University, St. Louis, Missouri 63110, United States; Not yet recruiting
Joy Snyder, M.D.

University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States; Recruiting
Yvette Sheline, M.D., Phone: 215-573-0082, Email: sheline@mail.med.upenn.edu
Yvette Sheline, M.D., Principal Investigator

Additional Information

Starting date: June 2014
Last updated: June 1, 2015

Page last updated: August 23, 2015

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