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Study Title Principal Investigator
Neuroimaging and endothelial function in vascular-related mild cognitive impairment
Identification of risk factors and biomarkers of neurodegenerative disease is essential in caring for the growing numbers of elderly. Imaging biomarkers provide non-invasive ways to look at brain function. A new PET imaging agent, Pittsburgh Compound B (PiB), that identifies brain amyloid is an exciting development in brain imaging that needs to be studied. We plan to study this imaging technique in normal volunteers and patients with a variety of neurodegenerative diseases to determine its utility. Long term followup of these subjects will allow us to understand the predictive ability of this new test.
Enrolling by invitation | Alzheimer's Disease | Not Multisite
Ihab Hajjar
Allopregnanolone Regenerative Therapeutic for MCI/AD: Dose Finding Phase I
Rationale: The first clinical trial to evaluate the safety and tolerability of allopregnanolone (Allo), a naturally occurring brain steroid, in mild cognitive impairment and Alzheimers disease participants. Allo is an investigational drug molecule shown in animal studies to stimulate the birth of new neurons, rescue cognition and lower indicators of Alzheimers disease. Objectives: 1) The first group of participants in the trial will be given one dose of Allo once per week for 12 weeks, only increasing the dose for the next group of participants when the lower dose has been shown to be safe. The primary goal is to determine the highest dose that is safe and tolerated by participants. 2) Analysis will also be done on blood samples taken from participants at the beginning and end of the trial to determine how the body responds to the drug molecule. 3) As per FDA requirements, the trial will investigate potential safety concerns including blood vessel changes via brain imaging. Secondary goals are to assess the short-term effects of Allo treatment on learning and memory as well as detect changes via MRI brain imaging to help researchers prepare for a larger-scale clinical trial. Study Population: The trial will enroll 24 participants (12 post-menopausal women, 12 men) diagnosed with mild cognitive impairment (MCI) or early Alzheimers disease. Participants must be 55 years of age or older, have a score on the Mini-Mental State Examination greater than 20, and be able to provide informed consent. Study Methodology: Participants will be given Allo or placebo intravenously once per week for 12 weeks. Description of Study Arms: Each dose (low to high) will have a separate, gender balanced group of 8 participants. 6 participants will be given Allo and 2 will be given placebo. At the end of the study, 18 participants will have received Allo and 6 will have received placebo. Endpoints: To determine the safety and tolerability of Allo, the trial will evaluate 1) if any, how much sedation after each dose of Allo; 2) if any, how many side-effects participants report; 3) any clinically significant changes in participants (for example: blood tests, weight, heart rate, heart monitor, brain scan, tests of memory) and 4) changes in brain imaging.
Recruiting | Alzheimer's Disease | Not Multisite
Roberta Brinton
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Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 15-Month Trial of TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease
Active, not recruiting | Alzheimer's Disease | Multisite
Lon Schneider
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A PHASE 0, OPEN LABEL, NON-RANDOMIZED, MULTI-CENTER, EXPLORATORY AND SAFETY STUDY OF [F-18]T808
Siemens Molecular Imaging (SMI) is seeking to determine if [F-18]T808 might be useful as a non-invasive assessment tool in the clinical evaluation of subjects with conditions associated with tau protein aggregates, such as Alzheimer's disease. The information collected under this exploratory study will not be used for diagnostic purposes, assessments of the participant's response to therapy or for clinical management of the participants. However, this exploratory study will provide baseline information on the safety, biodistribution, and dosimetry of [F-18]T808. These data will aid in the design of future studies of [F-18]T808 in patients with Alzheimer's disease. Overall, this study will provide initial data that inform the development of [F-18]T808 as the first PET imaging agent for human tau protein related pathology.
Terminated | Alzheimer's Disease | Multisite
Peter Conti
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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
A Phase IIa Multi-Center Study of 18F-FDG PET, Safety, and Tolerability of AZD0530 in Mild Alzheimer's Disease
Completed | Alzheimer's Disease | Multisite
Christopher Dyck
Therapeutic Effects of Intranasally-Administered Insulin in Adults With Amnestic Mild Cognitive Impairment (aMCI) or Mild Alzheimer's Disease (AD)
Active, not recruiting | Alzheimer's Disease | Multisite
Suzanne Craft
A Randomized, Double-blind, Placebo-controlled, Parallel-Group, 26-Week, Phase 3 Study of 2 Doses of EVP-6124 or Placebo in Subjects With Mild to Moderate Alzheimer's Disease Currently or Previously Receiving an Acetylcholinesterase Inhibitor Medication
Terminated | Alzheimer's Disease | Multisite
Lon Schneider
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Protocol H8A-MC-LZAZ (a) / ADC-040-A4 Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4 Study)
Alzheimers disease (AD) is an age-related neurodegenerative disorder characterized by progressive decline in cognitive function and ability to perform activities of daily living,and ultimately can lead to death due to complications of the disease. Pathologic hallmarks of AD identified at autopsy include the presence of neuritic amyloid-B (AB) plaques. The AB plaques are protein deposits that accumulate outside and around neurons. The AB hypothesis for AD, which states that the production and deposition of AB (later forming neuritic AB plaques) is an early and necessary event in the pathogenesis of AD, suggests that treatments that slow the synthesis or deposition of AB, or that increase clearance, might be expected to slow the progression of AD. One such treatment is immunotherapy. Solanezumab is a monoclonal antibody that is being developed as a passive immunization therapy to reduce AB burden. Converging evidence from both genetic at risk and age at risk cohorts suggests that the pathophysiological process of AD begins well more than a decade before the clinical stage now recognized as AD dementia, and that neurodegenerationis already apparent by the stage of Mild Cognitive Impairment (MCI) / prodromal AD. The A4 study will target those participants with evidence of brain amyloid pathology on PET amyloid imaging who are still clinically normal but at high risk for cognitive decline (defined as preclinical AD).Objectives: The primary objective of this study is to test the hypothesis that solanezumab, administered as an intravenous infusion at a dose of 400 mg every 4 weeks for 3 years, will slow the cognitive decline with placebo in participants with preclinical AD. Study Design: This is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 study comparing 400-mg solanezumab with placebo given as infusions once every 4 weeks 3 years in approximately 1150 outpatients with preclinical AD. Diagnosis and Main Criteria for Inclusion and Exclusions: Participants will be males and females 65 to 85 years old with preclinical AD. The study population is defined as participants with preclinical AD who have an MMSE score between 25 and 30, a Logical Memory test, part IIa score between 6 and 18, and a global CDR of 0; and having screening florabetapir PET scan indicating brain amyloid pathology.Efficacy: Preclinical Alzheimer Cognitive Composite (ADCS-PACC)Primary Analysis: The primary endpoint ADCS-PACC will be analyzed using an MMRM analysis.
Recruiting | Alzheimer's Disease | Multisite
Lon Schneider
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A PHASE 0, OPEN LABEL, NON-RANDOMIZED, MULTI-CENTER, EXPLORATORY AND SAFETY STUDY OF [F-18]T807
Siemens Molecular Imaging (SMI) is seeking to determine if [F-18]T807 might be useful as a non-invasive assessment tool in the clinical evaluation of subjects with conditions associated with tau protein aggregates, such as Alzheimer's disease. The information collected under this exploratory study will not be used for diagnostic purposes, assessments of the participant's response to therapy or for clinical management of the participants. However, this exploratory study will provide baseline information on the safety, biodistribution, and dosimetry of [F-18]T807. These data will aid in the design of future studies of [F-18]T807 in patients with Alzheimer's disease. Overall, this study will provide initial data that inform the development of [F-18]T807 as the first PET imaging agent for human tau protein related pathology.
Terminated | Alzheimer's Disease | Multisite
Peter Conti
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Effect of Passive Immunization on the Progression of Mild Alzheimer's Disease: Solanezumab (LY2062430) Versus Placebo
Active, not recruiting | Alzheimer's Disease | Multisite
Call hours
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy And Safety Study of Crenezumab in Patients With Prodromal to Mild Alzheimer's Disease
| Alzheimer's Disease | Multisite
Clinical Trials
A multicenter, open-label, long-term safety extension of phase II studies ABE4869g and ABE4955g in patients with mild to moderate alzheimer's disease
Active, not recruiting | Alzheimer's Disease | Multisite
Lon Schneider
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A Phase 3 Multicenter, Randomized, Double-Blind, PlaceboControlled,Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab(BIIB037) in Subjects with Early Alzheimer's Disease
| Alzheimer's Disease | Multisite
Lon Schneider
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