Science in Action: How You Can Help to Defeat AD
Clinical trials are the only way to test new drugs and advance treatment for Alzheimer’s disease. You are the key to the success. We need your help, we need you support. Your participation is key to finding a cure and prevention.
At the Cleveland Clinic Lou Ruvo Center for Brain Health, we are actively participating in the Alzheimer’s Disease Neuroimaging Initiative (ADNI). The program encompasses a group of studies being conducted at various sites nationwide with a goal of identifying the predictors of early AD through imaging tests and biomarkers found in blood and spinal fluid. The study employs Magnetic Resonance (MRI) scans to precisely measure brain volume, and PET scans with agents that can identify amyloid, an abnormal protein found in AD. By measuring changes in the brain over the course of AD, the ADNI study hopes to obtain information that will ultimately expedite the discovery of new treatments for the disease.
We will soon begin a nationwide study to examine the benefit of an antioxidant in treating early AD patients. We will collaborate with other AD academic centers worldwide to initiate a number of studies to investigate the effect of immunization against the early stage of Alzheimer’s disease.
The planning is under way for the first study to investigate a new blood test to diagnose Alzheimer’s disease. We are proud to take the scientific lead in such exciting, groundbreaking research.
For more information or to volunteer for a clinical trial, please contact Michelle B. Sholar, CRC at 702.483.6026 or sholarm@ccf.org, or Lal Ramani, CRC, at 702.483.6025 or ramanil@ccf.org.
Together, we will keep memory alive for many years and generations to come.
Meet the Research and Clinical Trials Team
Senior Director of Clinical Research and Development, Cleveland Clinic Lou Ruvo Center for Brain Health
Dr. Zhong is leading the clinical and research team conducting trials to advance treatment in Alzheimer’s disease, Parkinson’s disease and other neurodegenerative disorders, and brings over 15 years of diversified clinical and pharmaceutical research experience to the center. Dr. Zhong practiced as a geriatric psychiatrist, led clinical trials in Alzheimer’s disease, schizophrenia and mood disorders for AstraZeneca Pharmaceuticals, and served as a scientific consultant for multiple pharmaceutical, patient recruitment and rater training companies prior to joining Cleveland Clinic. She has a US patent pending invention featuring technology that enhances data quality of clinical trials.
Associate Medical Director, Cleveland Clinic Lou Ruvo Center for Brain Health
Dr. Charles Bernick has been involved in the field of Alzheimer’s disease research and treatment for close to 20 years. Since moving to Las Vegas in 1994, he has directed the development of a statewide network of Alzheimer's disease care, with clinics in Las Vegas, Reno and Elko. In addition to co-authoring numerous scientific articles, Dr. Bernick has participated in studies of virtually every medication now available for Alzheimer's disease.
LeeAnn Mandarino is the Administrative Program Manager for Research and Education, and is responsible for coordinating educational and scientific conferences for the Lou Ruvo Center for Brain Health.
Neural Effects of Exercise, Cognitive or Combined Training in Alzheimer’s Disease (AD) At-Risk Elders
Purpose:
The purpose of this study is to gain a better understanding of the effective of physical activity and/or cognitive training on brain function. This study will eventually determine if lifestyle changes can prevent AD and related disorders. Participation in the study lasts for 12 weeks and may include exercise training, cognitive training and MRI scans.
Eligibility:
Patients 60 to 85 years old with a family history of Alzheimer’s disease and good general health.
Location:
Lou Ruvo Center for Brain Health, Cleveland, OH
Principal Investigator:
Research Coordinator:
The Gammaglobulin Alzheimer’s Partnership (GAP) Study
Description:
A Randomized, Double-Blind, Placebo-Controlled, Two Dose-Arm, Parallel Study of the Safety and Effectiveness of Immune Globulin Intravenous for the Treatment of Mild-to-Moderate Alzheimer’s Disease
Purpose:
An 18-month study to determine whether gammaglobulin (IGIV) treatment will significantly slow the rate of decline in Alzheimer’s disease symptoms. IGIV treatment has been used extensively in clinical practice for more than 25 years to treat a variety of disorders. The safety profile of IGIV is well established in hundreds of thousands of patients worldwide, including many elderly individuals.
Eligibility:
Participants must be between 50 and 89 years of age, willing to receive an infusion of IGIV or placebo (albumin) every two weeks for 72 weeks and have a partner who is willing to be involved in the study.
Location:
Lou Ruvo Center for Brain health, Las Vegas, NV
Principal Investigator:
Research Coordinator:
Alzheimer’s Disease Neuroimaging Protocol Grand Opportunity (ADNI-GO)
Purpose:
Eighteen-month study to define and characterize the earliest stage of memory decline with MRI scans, PET scans, lumbar puncture, and memory and thinking assessments.
Eligibility:
Participants must be 45 to 90 years of age; have a mild memory complaint but no diagnosis of Alzheimer’s disease; and be willing to undergo memory testing, neuroimaging, two types of PET scans and at least one spinal tap. Each participant must have a partner willing to be involved in the study and to accompany the participant to each study visit.
Location:
Lou Ruvo Center for Brain Health, Las Vegas, NV
Principal Investigator:
Research Coordinator:
Parkinson Study
Twenty-seven month study to evaluate a range of doses of an investigational oral drug (preladenant) under development to treat Parkinson’s disease. Participants must be 30 to 85 years of age, have a diagnosis of early Parkinson’s disease and have stable or controlled blood pressure.
- For information or to volunteer, contact: Lal T. Ramani, CRC, 702.483.6025, ramanil@ccf.org
BMS STUDY
Purpose:
A 188-week study to evaluate the safety and tolerability of an investigational oral drug (BMS-708163) a Secretase Inhibitor. This is a potentially a disease-modifying agent that might alter the long-term course of memory decline and prevent the neurodegenerative process associated with Alzheimer’s disease.
Eligibility:
Participants must be 45 years of age or older, have mild memory complaints, be willing to undergo a spinal tap three times during the study, a safety MRI at regular intervals, and have a study partner willing to be involved in the study and accompany the participant to each study visit.
Location:
Lou Ruvo Center for Brain Health, Las Vegas, NV
Principal Investigator:
- For information or to volunteer, contact: Lal T. Ramani, CRC, 702.483.6025, ramanil@ccf.org
Impact of Florbetapir F 18 PET on the Clinical Diagnosis and Management of Patients with Progressive Cognitive Decline.
Purpose:
To evaluate whether a Florbetapir F 18 PET scan can effectively assist physician in providing a diagnosis for the likely cause of the subject’s progressive cognitive impairment. To estimate the percentage of participants who undergo a change in clinical diagnosis after obtaining a Florbetapir F 18 PET scan. To compare the change in certainty of the clinical diagnosis after obtaining a Florbetapir F 18 PET scan among participants in whom the clinical diagnosis remains unchanged. To compare the physician management plan prior to obtaining a Florbetapir F 18 PET scan to the physician management plan after an F 18 PET scan has been obtained.
Eligibility:
Participants who, within last 18 months, have completed a comprehensive clinical evaluation and have evidence of progressive cognitive decline or are currently being evaluated for progressive cognitive decline. Site enrolling physician has substantial uncertainty regarding the diagnosis; however a diagnosis of Alzheimer’s disease is considered a potential etiology for the cognitive decline.
Location:
Lou Ruvo Center for Brain Health, Las Vegas, NV
Principal Investigator:
Research Coordinator:
Performance of AclarusDx™, a Blood-Based Transcriptomic Test for Alzheimer’s Disease, in U.S.-Based Patients Suffering from Memory Impairment and Newly Referred to a Reference Memory Center for AD Diagnostic Workup: A Pilot Descriptive Study
Purpose:
To assess the performance of a blood medical test, AclarusDx, intended to help physicians in making an Alzheimer’s disease diagnosis in patients having memory impairments.
Eligibility:
Participants with memory impairment may be either referred by PCP or self-referred.
Location:
- Lou Ruvo Center for Brain Health; Las Vegas, NV
- Cleveland Clinic Main Campus; Cleveland, OH
- Lakewood Hospital; Lakewood, OH
Principal Investigators:
Research Coordinators:
- Carol Varela, CCRC; Las Vegas, NV, 702.331.7053;
- Christine Whitman, RN, CCRC; Cleveland & Lakewood, OH, 216.227.2438
Alzheimer’s Vaccine Study for Mild to Moderate Alzheimer’s Disease
Purpose:
A 24-month study to evaluate the safety and tolerability of an investigational, intramuscular injection of an experimental immunotherapy (ACC-001) under development to alter the course of memory decline in patients with prodromal Alzheimer’s disease.
Eligibility:
Participants must be 50 or older and be willing to receive six intramuscular injections within a 24-month period; and to undergo memory testing, neuroimaging (MRI and PET scans) and two lumbar punctures. Each participant must have a study partner willing to be involved in the study and accompany the participant on each visit.
Location:
Lou Ruvo Center for Brain Health, Las Vegas, NV
Principal Investigator:
Research Coordinator:
Neural and Behavioral Sequelae of Blast-Related Traumatic Brain Injury
Purpose:
To gain a better understanding of the effects of blast-related traumatic brain injury (TBI) vs. non-blast TBI and orthopedic injury. This study will provide useful information on the neural effects of blast exposure. Participation consists of one day of cognitive testing and MRI scans.
Eligibility:
Participants must be in one of the following categories: military personnel or veterans who have had combat experience during the past 12 to 72 months OR civilians who have experienced a mild to moderate TBI or orthopedic injury in the past 12 to 72 months.
Location:
Lou Ruvo Center for Brain Health, Cleveland, OH
Principal Investigator:
Research Coordinator:
PROFESSIONAL FIGHTERS CLINICAL RESEARCH STUDY
Purpose:
It will help determine whether magnetic resonance imaging (MRI) of the brain, along with other tests, can detect subtle changes in brain health. Researchers hope to identify if and when changes occur that may result in impaired thinking and functioning.
The first visit will last approximately two hours. Participants will answer basic questions about their background, personal and family medical history, and sports experience; undergo a noninvasive and painless MRI scan of the brain, and a neurological examination; participate in brief computer and verbal tests to measure memory and other aspects of mental functioning. Any changes seen on the participant’s MRI will be correlated with their performance on cognitive assessments and neurologic exams. This information may help us find ways to identify those who are at risk for brain injury. Participants will be asked to repeat the study once a year for four years so that any changes to their brains will be noted and monitored.
Eligibility:
Participants must be: Age 18 or older; licensed or seeking licensure in the state of Nevada for professional fighting (unarmed combat), including boxing, mixed martial arts, and muay thai; read and speak English. Abnormal findings will be discussed privately with the study participant. No information will be released to any other person, agency, or to the Nevada Athletic Commission without the participant’s written permission. If a finding represents a health risk, we will discuss whether the participant would like us to forward the information to his or her personal physician. If we believe the finding puts the athlete at risk for continued participation in the sport, we will inform the participant and it will be his or her responsibility to notify the licensing agency.
Location:
Lou Ruvo Center for Brain Health, Las Vegas, NV
Principal Investigator:
- For information or to volunteer, contact: Michelle Sholar, CRC, 702.483.6026, sholarm@ccf.org
