Escitalopram for Agitation in Alzheimer's Disease



Status:Recruiting
Conditions:Alzheimer Disease, Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 109
Updated:1/19/2019
Start Date:January 3, 2018
End Date:August 2022
Contact:Dave Shade, JD
Email:dshade@jhmi.edu
Phone:4109558175

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The purpose of this study is to evaluate the safety and efficacy of escitalopram for
agitation in Alzheimer's dementia.

This study is designed to examine the efficacy and safety of escitalopram as treatment for
agitation in Alzheimer's dementia (AD) patients. Participants with clinically significant
agitation, and their caregiver(s), will receive a structured psychosocial intervention.
Participants not showing a response three weeks later will be randomized 1:1 to escitalopram
(up to 15 mg/day) or a matching placebo. Participants will receive study drug for 12 weeks,
with in-person visits at weeks 3, 6, 9, and 12, and with telephone contacts between in-person
visits. Following the 12-week study treatment period, participants will be followed for
another 12 weeks without receiving study drug. Participants who do show a response to the
psychosocial intervention will not be randomized to study drug but will be followed for the
24-week follow-up period.

Inclusion criteria

1. Alzheimer's dementia diagnosed clinically by the National Institute on Aging (NIA) and
the Alzheimer's Association (AA) (2011 NIA/AA criteria)

2. Mini-Mental State Examination (MMSE) score of 5-28 inclusive

3. Meets the International Psychogeriatric Association (IPA) provisional criteria for
agitation in cognitive disorders

4. Clinically significant agitation/aggression as assessed by the Neuropsychiatric
Inventory (NPI) for which either:

- The frequency is 'Very frequently,' or

- The frequency is 'Frequently' AND the severity is 'Moderate' or 'Marked'

5. Provision of informed consent for participation in the study by both caregiver and
participant (or, if participant is unable to provide informed consent, with surrogate
consent and participant assent)

6. Availability of a caregiver who spends at least several hours per week with the
participant, supervises his/her care, is willing to accompany the participant to study
visits, and is willing to participate in the study

7. Stable (for ≥ 7 days) dosing of antipsychotics for agitation or psychosis, if being
used at all

8. A medication for agitation is appropriate, in the opinion of the study physician

Exclusion criteria

1. Has major depression, as indicated by major depressive episode (MDE) in the past 90
days (meeting the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition
(DSM-V) criteria)

2. Presence of another brain disease that fully explains the dementia, (e.g., extensive
brain vascular disease, Parkinson's disease, dementia with Lewy bodies, traumatic
brain injury, or multiple sclerosis)

3. Residence in a skilled nursing or Long-Term Acute Care (LTAC) facility

4. Contraindication to treatment with escitalopram as determined by a study physician,
such as recent (30 days) use of monoamine oxidase inhibitors (MAOIs) or potential
participant is hypersensitive to escitalopram or citalopram or any inactive
ingredients

5. Prior failed treatment attempt with citalopram or escitalopram for agitation after
adequate trial, at minimally accepted dose

6. Indication for psychiatric hospitalization or acute suicidality, in the opinion of the
study physician

7. Recent (< 7 days) changes in antipsychotics (including brexpiprazole), or psychosis
(delusions or hallucinations) requiring a new or change in antipsychotic treatment (in
the opinion of the study physician)

8. Abnormal corrected QT interval using Bazett's formula (QTcB) as determined on
enrollment ECG (defined as > 450 ms for men and > 470 ms for women)

9. Recent (30 days) presence of severely reduced renal function (as identified by a
Glomerular filtration rate (GFR) clearance < 30 mL/min) or reduced hepatic function

10. Current treatment (within 7 days) with any of the following:

- anticonvulsants (other than Dilantin for seizures)

- antidepressants (other than trazodone, ≤ 50 mg per day at bedtime)

- benzodiazepines (other than lorazepam), or

- psychostimulants

11. Recent (< 14 days) changes in Dextromethorphan/quinidine, prazosin, and pimavanserin

12. Recent (< 14 days) use of medical marijuana

13. Current participation in a clinical trial or in any study that may add a significant
burden or affect neuropsychological or other study outcomes

14. Significant communicative impairments that would affect participation in a clinical
trial

15. Any condition that, in the opinion of the study physician, makes it medically
inappropriate or risky for the potential participant to enroll in the trial
We found this trial at
22
sites
4940 Eastern Avenue
Baltimore, Maryland 21224
Principal Investigator: Paul Rosenberg, MD
Phone: 410-550-9022
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Principal Investigator: Davangere P. Devanand, MD
Phone: 646-774-8671
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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New York, NY
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Principal Investigator: Anton Porsteinsson, MD
Phone: 585-760-6562
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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500 South State Street
Ann Arbor, Michigan 48109
Principal Investigator: Helen Kales, MD
Phone: 734-232-0393
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Baltimore, Maryland 21285
Principal Investigator: Scott Tyler Aaronson, MD
Phone: 410-938-3135
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Baltimore, Maryland 21202
Principal Investigator: John Kasckow, MD
Phone: 410-605-7358
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Bellevue, Washington 98007
Principal Investigator: Shirin Schilling, MD
Phone: 425-453-0404
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Calgary, Alberta
Principal Investigator: Zahinoor Ismail, MD
Phone: (403) 210-7737
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Calgary,
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Charleston, South Carolina 29401
Principal Investigator: Jacobo Mintzer, MD
Phone: 843-724-2053
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Charleston, SC
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303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Principal Investigator: Michael Schrift, MD
Phone: 312-503-7071
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Douglas Scharre, MD
Phone: 614-293-9023
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, OH
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Dallas, Texas 75219
Principal Investigator: Cindy Marshall, MD
Phone: 214-818-2736
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Glen Burnie, Maryland 21061
Principal Investigator: Lawrence Adler, MD
Phone: 410-768-2629
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Irvine, California 92614
Principal Investigator: Elly Lee, MD
Phone: 949-753-1663
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Las Vegas, Nevada 89106
Principal Investigator: Alan Ritter, MD
Phone: 702-701-7893
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Little Rock, Arkansas
Principal Investigator: Prasad Padala, MD
Phone: 501-257-2537
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Los Angeles, California 90073
Principal Investigator: David Sultzer, MD
Phone: 310-478-3711
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Los Angeles, California 90089
Principal Investigator: Lon S. Schneider, MD
Phone: 323-442-7594
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Miami, Florida 33137
Principal Investigator: Marc Agronin, MD
Phone: 305-751-8626
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200 Lothrop Street
Pittsburgh, Pennsylvania 15213
Principal Investigator: Oscar Lopez, MD
Phone: 412-692-2703
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54 Miller Street
Quincy, Massachusetts 02169
Principal Investigator: Anil Nair, MD
Phone: 617-302-6388
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Willow Grove, Pennsylvania 19090
Principal Investigator: David Weisman, MD
Phone: 215-957-9250
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