Trial record 20 of 601 for:
ESCITALOPRAM
Escitalopram for Agitation in Alzheimer's Disease (S-CitAD)
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| ClinicalTrials.gov Identifier: NCT03108846 |
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Recruitment Status :
Recruiting
First Posted : April 11, 2017
Last Update Posted : January 17, 2019
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Sponsor:
JHSPH Center for Clinical Trials
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Dave Shade, JHSPH Center for Clinical Trials
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Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of escitalopram for agitation in Alzheimer's dementia.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Dementia | Drug: Escitalopram Drug: Placebo | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 392 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | Over-encapsulation |
| Primary Purpose: | Treatment |
| Official Title: | Escitalopram for Agitation in Alzheimer's Disease |
| Actual Study Start Date : | January 3, 2018 |
| Estimated Primary Completion Date : | December 2021 |
| Estimated Study Completion Date : | August 2022 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Alzheimer disease
| Arm | Intervention/treatment |
|---|---|
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Experimental: Escitalopram
Escitalopram up to 15mg/day taken as 1-3 capsules each containing 5mg escitalopram once per day in the morning
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Drug: Escitalopram
5-15 mg/day (target: 15mg/day if tolerated)
Other Name: Lexapro |
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Placebo Comparator: Placebo
1-3 capsules each containing placebo only once per day in the morning
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Drug: Placebo
Masked placebo
Other Name: non-applicable |
Primary Outcome Measures :
- modified- Alzheimer's Disease Cooperative Study--Clinical Global Impression of Change (mADCS-CGIC) [ Time Frame: after 12 weeks ]Clinical Global Impression of Change
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| Ages Eligible for Study: | 18 Years to 109 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria
- Alzheimer's dementia diagnosed clinically by the National Institute on Aging (NIA) and the Alzheimer's Association (AA) (2011 NIA/AA criteria)
- Mini-Mental State Examination (MMSE) score of 5-28 inclusive
- Meets the International Psychogeriatric Association (IPA) provisional criteria for agitation in cognitive disorders
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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'
- 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)
- 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
- Stable (for ≥ 7 days) dosing of antipsychotics for agitation or psychosis, if being used at all
- A medication for agitation is appropriate, in the opinion of the study physician
Exclusion criteria
- 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)
- 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)
- Residence in a skilled nursing or Long-Term Acute Care (LTAC) facility
- 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
- Prior failed treatment attempt with citalopram or escitalopram for agitation after adequate trial, at minimally accepted dose
- Indication for psychiatric hospitalization or acute suicidality, in the opinion of the study physician
- 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)
- 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)
- 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
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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
- Recent (< 14 days) changes in Dextromethorphan/quinidine, prazosin, and pimavanserin
- Recent (< 14 days) use of medical marijuana
- Current participation in a clinical trial or in any study that may add a significant burden or affect neuropsychological or other study outcomes
- Significant communicative impairments that would affect participation in a clinical trial
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03108846
Contacts
| Contact: Dave Shade, JD | 4109558175 | dshade@jhmi.edu | |
| Contact: Stephan Ehrhardt, MD | 4109558175 | sehrhar6@jhu.edu |
Locations
Show 26 study locations
Sponsors and Collaborators
JHSPH Center for Clinical Trials
National Institute on Aging (NIA)
Investigators
| Study Chair: | Constantine Lyketsos, MD, MHS | Johns Hopkins University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dave Shade, Director, S-CitAD Coordinating Center, JHSPH Center for Clinical Trials |
| ClinicalTrials.gov Identifier: | NCT03108846 |
| Other Study ID Numbers: |
S-CitAD R01AG052510 ( U.S. NIH Grant/Contract ) |
| First Posted: | April 11, 2017 Key Record Dates |
| Last Update Posted: | January 17, 2019 |
| Last Verified: | January 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
Keywords provided by Dave Shade, JHSPH Center for Clinical Trials:
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Alzheimer's Disease Agitation |
Additional relevant MeSH terms:
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Dexetimide Citalopram Alzheimer Disease Psychomotor Agitation Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Dyskinesias Neurologic Manifestations Psychomotor Disorders |
Neurobehavioral Manifestations Signs and Symptoms Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Antiparkinson Agents Anti-Dyskinesia Agents Parasympatholytics |