A Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of AVP-786 (deuterated [d6]-dextromethorphan hybrobromide [d6-DM]/quindine sulfate [Q]) for the treatment of agitation in patients with dementia of the Alzheimer's type. Save

Date Added
March 28th, 2017
PRO Number
Pro00064742
Researcher
Olga Brawman-mintzer

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Keywords
Alzheimers
Summary

The objectives of the study are to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in patients with dementia of the Alzheimer's type.

Institution
MUSC
Recruitment Contact
Keaveny Donovan
843-577-5011,extension 5188
keaveny.donovan@va.gov

A Randomized, Double-Blind, Placebo-Controlled and Delayed-Start Study of LY3314814 in Mild Alzheimer's Disease Dementia (The DAYBREAK Study) Save

Date Added
August 23rd, 2016
PRO Number
Pro00057163
Researcher
David Clark

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Keywords
Alzheimers, Dementia, Drug Studies
Summary

Subjects are being asked to volunteer for a research study because they have been diagnosed with Alzheimer's disease. Alzheimer's dementia is the most common form of dementia. It is a general term for memory loss and loss of other intellectual abilities that are serious enough to interfere with daily activities.

The purpose of this study is to see if the investigational drug, LY3314814 (study drug) can slow the progression of your Alzheimer's disease. In Part I of the study, subjects will either receive the study drug or placebo. After 78 weeks, all subjects will begin Part II where everyone is on the study drug.

Institution
MUSC
Recruitment Contact
John Keller
843-792-2209
kellej@musc.edu

Apathy in Dementia Methylphenidate Trial 2 (ADMET 2) Save

Date Added
September 23rd, 2015
PRO Number
Pro00043151
Researcher
Jacobo Mintzer

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Keywords
Aging, Alzheimers, Brain
Summary

With this research study, we want to learn if methylphenidate (Ritalin® and others) helps people with Alzheimer's disease and apathy (lack of interest or concern for things that others find moving or exciting).

Institution
MUSC
Recruitment Contact
Catherine Danner
843-724-2302
catherine.danner@rsfh.com

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects with Early Alzheimer's Disease Save

Date Added
September 8th, 2015
PRO Number
Pro00044560
Researcher
David Clark

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Keywords
Alzheimers, Memory Loss
Summary

This study will be conducted in subjects with early AD, including subjects with mild cognitive impairment (MCI) due to AD and a subset of mild AD.

The purpose of this study is to find out whether (study drug) has the potential to be a helpful treatment that slows down disease progression in subjects with early Alzheimer's Disease (AD) by comparing it to placebo and to evaluate its safety (side effects), and to find out more about aducanumab.

The subject will have the option of participating in four sub-studies: DNA, positron emission tomography (PET), magnetic resonance imaging (MRI), cerebrospinal fluid (CSF) or the Long Term Extension study (LTE).

Study duration for each subject participating in the placebo-controlled period only will be approximately 102 weeks (up to an 8 week Screening Period, 76 weeks of placebo or aducanumab dosing, and 18 weeks of follow-up).

For subjects who enter the optional LTE, the total duration will be approximately 206 weeks or 47 months (up to an 8 week Screening Period, 76 weeks of placebo or aducanumab dosing, 4 weeks of follow-up, 100 weeks of dose-blind aducanumab dosing, and 18 weeks of follow-up).

Institution
MUSC
Recruitment Contact
Michele DeCandio
2-9016
decandio@musc.edu

Story-Call: e-mobile support for community caregivers of Veterans with dementia Save

Date Added
August 20th, 2014
PRO Number
Pro00035867
Researcher
Charlene Pope

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Keywords
Alzheimers
Summary

Alzheimer's disease and the isolation it produces imposes a heavy burden on informal caregivers (CG) of Veterans who are persons with dementia (PWD), who carry greater burden than those caring for persons with other chronic diseases. This feasibilty study will test a mobile application (APP) on a mini-iPad designed for caregivers of community-dwelling Veterans who are PWD in comparison with Web-based informational materials. Building on story-telling interventions effective in other chronic diseases, this feasibilty study proposes Story-Call as a newly-developed mobile application that records, archives, and presents 30/60-second videos by caregivers and professionals, who share brief stories about how they have handled common dementia home-care situations, such as "She wants to go home!" A qualitative component will categorize themes from stories and in 2 phases collect: 1) perceptions from follow-up phone interviews with CG participants; and 2) focus groups with Advisory Group and VA stakeholders as a process evaluation of APP appeal, use, impact, and cultural tailoring. The expected outcomes will examine if CGs find that the APP-recorded stories decrease perceived CG burden and increase social support as efficacy, while confirming feasibility in recruitment, acceptability, practicality, increased adaptation to dementia care, and use of community resources for future scaling up and testing.

Institution
MUSC
Recruitment Contact
Charlene Pope
843-789-6577
Charlene.Pope@va.gov

The MIND Study: MR Imaging of Neurodegeneration Save

Date Added
September 18th, 2013
PRO Number
Pro00028302
Researcher
Andreana Benitez

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Keywords
Aging, Alzheimers, Brain, Dementia, Geriatrics, Healthy Volunteer Studies, Memory Loss
Summary

This is a study of brain aging and Mild Cognitive Impairment (MCI). In this study, we use non-invasive brain MRI techniques and tests of memory and other thinking skills to improve the detection of brain diseases of aging at the very earliest stages. A fasting blood draw will also be performed to help clarify the contribution of blood sugar and cholesterol to brain aging. We are primarily recruiting 80 individuals ages 65-85 who have been diagnosed with Mild Cognitive Impairment (MCI) by their healthcare provider. We are also recruiting individuals ages 65-85 who are cognitively healthy and do not have any significant or unstable medical conditions. This study is sponsored by the NIH and is conducted at MUSC.

If you are interested in this study, please contact us by phone or through: http://bit.ly/MIND-study

Institution
MUSC
Recruitment Contact
Anne Sorrell
(843) 876-2475
sorrella@musc.edu

Physician Order for Scope of Treatment (POST): PILOT STUDY Save

Date Added
August 6th, 2013
PRO Number
Pro00022252
Researcher
Walter Limehouse

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Keywords
Aging, Alzheimers, Cancer, Dementia, Ethnicity and Disease, Geriatrics, Heart, HIV / AIDS, Infectious Diseases, Kidney, Liver, Men's Health, Minorities, Nervous System, Pulmonary, Rare Diseases, Women's Health
Summary

South Carolina Coalition for Care of Serious Illness (SCC CSI) sponsors development of Physician Orders for Scope of Treatment (POST) in South Carolina. The SC POST follows the national POLST (www. polst.org) paradigm creating an advance treatment planning physician order that migrates as valid across institutional boundaries: from physician office, to home/nursing home/hospice to EMS to hospital emergency/inpatient services. The POST form encourages a conversation between a physician and the patient regarding treatment options available to seriously ill patients for whom death within a year would not be a surprise. These choices primarily include whether to attempt cardiopulmonary resuscitation in the event of cardiac or pulmonary arrest or not (a "DNR" or "Allow Natural Death" order) and whether during acute illness to provide full treatment including endotracheal intubation and intensive care, supportive treatment such as noninvasive ventilation and no intensive care, or comfort care only. The Charleston and Greenville areas will pilot POST. Investigators by area will survey providers completing POST documents for patients or treating patients with POST about the utility of this form and how use of the form affected their patient's treatment. A chart reviews of patients presenting with a POST form to a hospital emergency or inpatient unit will address whether providers respected patient treatment choices. SCC CSI plans to publish the results of the pilot in appropriate journals and present the results at medical meetings and to interested persons. The results of the study may provide the supporting documentation for subsequent legislation supporting POST. POST represents a coordinated statement of a seriously ill patient's treatment choices to be honored across multiple treatment settings.

Institution
MUSC
Recruitment Contact
Walter Limehouse
792-9705
limehouw@musc.edu

Effects of traumatic brain injury and post traumatic stress disorder on Alzheimer's disease (AD) in Veterans using ADNI (DOD ADNI) Save

Date Added
March 19th, 2013
PRO Number
Pro00020335
Researcher
Jacobo Mintzer

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Keywords
Alzheimers
Summary

From the VA and military records, a sample of Veterans 50-90 years old who served in the Vietnam War and meet the criteria of each of the study groups, PTSD, TBI, and comparable controls will be obtained. Those subjects between 60-80 years of age will be selected first. Those between 50-59 years of age, as well as those over 80 years may be recruited later in the project should recruitment numbers be too low in the 60-80 year age range.

Institution
MUSC
Recruitment Contact
Marilyn Stuckey
843-740-1592
stuckeym@musc.edu

A Multi-Center Randomized Placebo-Contolled Clinical Trial Study of Citalopram for the treatment of Agitation in Alzheimer's Disease (CITAD) Save

Date Added
October 5th, 2009
IRB Number
18350
Researcher
Jacobo Mintzer

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Keywords
Aging, Alzheimers, Anxiety, Brain, Dementia, Geriatrics, Memory Loss, Mental Health
Summary

This study is designed to examine the effects and safety of citalopram in patients with Alzheimer's disease experiencing agitation or emotional disturbance. This study is 9 weeks long. In order to participate in this study, you must be at least 45 years old, have Alzheimer's disease and experience agitation. Participants cannot have depression. Participants may stay on approved memory medications for Alzheimer's disease.

Institution
MUSC
Recruitment Contact
Marie Corbin
843-740-1592
corbinm@musc.edu

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