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Clinical Trials and Studies

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Study Title Principal Investigator
Testing a new drug to reduce anxiety and agitation in people with Alzheimer's disease and dementia
<p>A person with Alzheimer's often feels anxious or upset easily. They might be restless, unable to sleep or pace back and forth. These problems, called agitation, can keep them from a normal day-and-night routine and might become harmful for your loved one or their caregivers. </p><p>Can FDA-approved medication that treats sadness and anxiety also help with agitation? USC Alzheimer Disease Research Center is looking for volunteers with any form of dementia (Alzheimer's disease) to join our 24-week study of Escitalopram to reduce agitation. </p><p>Volunteers and their caregivers will receive structured and personalized resources and therapies. Participants will receive Escitalopram for 12 weeks, with in-person visits at weeks 3, 6, 9, and 12, and with telephone contacts between in-person visits.</p>
Recruiting | Alzheimer's Disease | Not Multisite
Lon Schneider, MD
Testing a new drug to prevent Alzheimer's disease and dementia
<p>Do any of your friends, family, or loved ones have problems remembering or have developed Alzheimer’s disease? The USC Alzheimer Disease Research Center is testing how well a drug may help to prevent the loss of memory. The research team is looking for volunteers (ages 60 to 75) who do not have signs of cognitive problems (meaning that their speech, thinking, and memory are fine compared to other people of the same age). </p><p>If you're eligible and choose to take part, you'll be one of the few people that can join the fight against Alzheimer's disease. But preventing such a disease won't happen overnight. The trial will run for between 5 and 8 years.</p>
Recruiting | Alzheimer's Disease | Not Multisite
Lon Schneider, MD
Investigating efficacy and safety of adjunctive therapy in Parkinson’s Disease patients
Parkinson’s Disease involves the loss of brain cells that produce dopamine, a messenger that sends information to the parts of the brain that control movement and coordination. Lower than normal levels of dopamine in the brain causes the symptoms of Parkinson’s, including muscle stiffness, resting tremor (uncontrollable shaking), and slowing of movements. Parkinson’s patients may have “on” periods where they are able to control their muscle movement, and “off” times when controlling these movements is harder. Levodopa is a medication used to help treat Parkinson’s by increasing dopamine levels in the brain. We are looking for participants who have these “on” and “off” periods, and who are on Levodopa and at least one other medication. We are looking at whether adding tozadenant, a drug that hasn’t been approved by the U.S. FDA, will help improve Parkinson’s symptoms.
Recruiting | parkinsons adjunctive therapy | Not Multisite
Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Lu AE58054 in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil
Recruiting | Alzheimer's Disease | Multisite
Email A/S
International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)
BACKGROUND: Evidence supporting a routine invasive practice paradigm for patients with stable ischemic heart disease (SIHD) is outdated. In strategy trials conducted in the 1970s, coronary artery bypass grafting (CABG) improved survival as compared with no CABG in SIHD patients with high-risk anatomic features. The relevance of these studies today is speculative because contemporary secondary prevention—aspirin, beta-blockers, statins, ACE inhibitors, and lifestyle interventions—were used minimally if at all. Subsequent trials have compared percutaneous coronary intervention (PCI) with medical therapy, as PCI has replaced CABG as the dominant method of revascularization for SIHD. To date, PCI has not been shown to reduce death or myocardial infarction (MI) compared with medical therapy in SIHD patients. COURAGE and BARI 2D, the two largest trials comparing coronary revascularization vs. medical therapy in SIHD patients, found that among patients selected on the basis of coronary anatomy after cath, an initial management strategy of coronary revascularization (PCI, PCI or CABG, respectively) did not reduce the primary endpoints of death or MI (COURAGE), or death (BARI 2D) compared with OMT alone. These data suggest, but do not prove, that routine cath--which often leads to ad hoc PCI through the diagnostic-therapeutic cascade--may not be required in SIHD patients. However, most patients enrolled in COURAGE and BARI 2D who had ischemia level documented at baseline had only mild or moderate ischemia, leaving open the question of the appropriate role of cath and revascularization among higher risk patients with more severe ischemia. Observational data suggest that revascularization of patients with moderate-to-severe ischemia is associated with a lower mortality than medical therapy alone, but such data cannot establish a cause and effect relationship. In clinical practice only about half such patients are referred for cath, indicating equipoise. Furthermore, analysis of outcomes for 468 COURAGE patients with moderate-to-severe ischemia at baseline did not reveal a benefit from PCI. This issue cannot be resolved using available data because all prior SIHD strategy trials enrolled patients after cath, introducing undefined selection biases (e.g., highest risk patients not enrolled) and making translation of study results problematic for clinicians managing patients who have not yet had cath. A clinical trial in SIHD patients uniformly at higher risk (which could not have been performed before COURAGE and BARI 2D results were available) is needed to inform optimal management for such patients. DESIGN NARRATIVE: The study protocol is final, and was distributed to sites February 2012. Study protocol v2.0 was approved in January 2014. PARTICIPATING COUNTRIES: North America - Canada - Mexico - USA (~150 sites) South America - Argentina - Brazil - Chile - Peru Asia - China - India - Japan - Singapore - Taiwan - Thailand - Russian Federation Pacifica - Australia - New Zealand Europe - Austria - Belgium - Denmark - France - Germany - Hungary - Italy - Lithuania - Macedonia - Netherlands - Poland - Portugal - Romania - Serbia - Spain - Sweden - UK Middle East - Israel - Saudi Arabia - Turkey
Recruiting | Atherosclerosis | Multisite
Judith Hochman
Non-interventional Study for the Generation of Long Term Safety and Efficacy Data of Pasireotide s.c. in Patients With Cushing's Disease (Post-Authorization Safety Study)
Recruiting | | Multisite
Novartis Pharmaceuticals
Tracking the Risk for Alzheimer’s Disease using the APT Webstudy
The Alzheimer Prevention Trials (APT) Webstudy is designed to accelerate enrollment into Alzheimer’s clinical trials by identifying and tracking individuals online, who may be at higher risk for developing Alzheimer’s. The Alzheimer’s Association estimates that 5.5 million Americans age 65 and older are currently living with Alzheimer’s dementia. It’s believed these numbers will increase by almost 30% to over 7 million people by 2025, where it’s the only top 10 cause of death that cannot be prevented, cured, or even slowed. The APT Webstudy is open to anyone over the age of 50. The goal of the APT Webstudy is to develop an online group of individuals who will allow their memory and thinking test scores to be tracked over time. Participants will have the opportunity to take online tests to assess their memory and thinking skills, gain access to their scores, and be notified of opportunities for in-person assessments and clinical trials aimed at preventing dementia. These in-person visits will be offered through the closest clinical site to participants.
Recruiting | alzheimer | Not Multisite
Paul Stephen Aisen, MD
A Phase 1b, Multicenter, Double-blind, Randomized, Placebo-controlled, Single Ascending-Dose, Clinical Study Evaluating the Safety, Tolerability and Exploratory Efficacy of a Targeted Single Injection of an Intradiscal Nuclear Factor-κB Decoy Oligodeoxynucleotide (AMG0103) in Subjects With Chronic Discogenic Lumbar Back Pain
This is a Phase 1b, multicenter, double-blind, single ascending dose study designed to evaluate the safety of AMG0103 in adult male and female subjects with chronic discogenic lumbar back pain. This protocol anticipates that 8 subjects with symptomatic single level discogenic pain will be enrolled in each of up to 3 dose-escalation cohorts. Subjects in each cohort will receive AMG0103 or Placebo as a targeted, single, intradiscal injection.
Recruiting | | Multisite
AnGes
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