Biomarker trials recruiting in the United States

(Data are as of July 24, 2009. Only select studies and criteria are given; see ClinicalTrials.gov for complete information.)

Biomarkers and Early Alzheimer's Disease
Sponsored by: National Institute on Aging
ClinicalTrials.gov #: NCT00094952
Study Phase: Not applicable

Study Location(s) and Contact Information
Center for Brain Health, Silberstein Institute
New York University School of Medicine
New York, New York 10016
Kenneth E. Rich, 1.212.263.7563
kenneth.rich@med.nyu.edu

Study Purpose
This project aims to identify cognitively normal older adults who are at increased risk for developing mild cognitive impairment, a condition that often precedes Alzheimer's disease. The researchers will study participant brain scans and samples of cerebrospinal fluid—the fluid that surrounds the brain—to search for Alzheimer-related molecules. A second goal of the project is to determine if physical signs of Alzheimer’s are related to changes in cognitive ability.

You may qualify if you

• are between 60 and 80 years of age
• have at least a high school education
• are living in the New York City metropolitan area
• are in good mental and physical health

• have had trauma, stroke or another serious brain disorder
• have a history of alcoholism or drug abuse
• have a history of depression or other psychiatric illness
• have had heart or blood vessel diseases or risk factors for these diseases, including uncontrolled high blood pressure
• have a pacemaker or other prosthetic device that could be affected by the magnetic field employed during imaging procedures
• have a family history of early-onset dementia

Observational Study of Cognitive Outcomes for Subjects Who Have Had Prior PET Amyloid Imaging With Florpiramine F 18 (18F-AV-45)
Sponsored by: Avid Radiopharmaceuticals
ClinicalTrials.gov #: NCT00857506
Study Phase: Phase II

Study Location(s) and Contact Information
Eight study locations around the United States
Michael J Pontecorvo, Ph.D., 1.215.966.6221
pontecorvo@avidrp.com
Alan P Carpenter, Ph.D., 1.215.966.7173
carpenter@avidrp.com

Study Purpose
This follow-up study will assess whether an imaging technique can accurately diagnose Alzheimer’s disease and mild cognitive impairment—a condition that often precedes Alzheimer’s—in study participants. The technique uses a compound that binds to and highlights the protein fragment beta-amyloid, a key suspect in Alzheimer’s, on brain scans.

You may qualify if you

• have enrolled in the study entitled “A Phase II Trial of 18F-AV-45 Positron Emission Tomography (PET) Imaging in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)” (ClinicalTrials.gov identifier: NCT00702143) and completed an imaging scan

Safety and Efficacy of Positron Emission Tomography Imaging With BAY 94-9172 (ZK 6013443)
Sponsored by: Bayer
ClinicalTrials.gov #: NCT00750282
Study Phase: Phase II

Study Location(s) and Contact Information
20 study locations in the United States, Australia, Germany, and Switzerland
Bayer Clinical Trials, 1.888.842.2937
clinical-trials-contact@bayerhealthcare.com

Study Purpose
This study will evaluate whether the compound BAY 94-9172 (ZK 6013443) can be used to detect the development of Alzheimer’s disease on brain imaging scans. This compound binds to the protein fragment beta-amyloid, a key suspect in Alzheimer’s, and can highlight disease-related amyloid accumulation on the scans.

• are more than 55 years of age
• have been diagnosed with Alzheimer's
• have a reliable caregiver who can participate in study sessions

You may not qualify if you

• have a non-Alzheimer form of brain disease
• have had a stroke or a cerebrovascular disease
• have an inflammatory or infectious central nervous system disease, such as multiple sclerosis or syphilis
• are scheduled for surgery or another invasive procedure
• have a history of exposure to any radiation
• are receiving chemotherapy or similar treatment
• are allergic to the drugs used in this study
• have participated in a clinical study involving an investigational drug within 30 days before screening
• have a history of alcohol or drug abuse
• have a history of severe, persistent depression
• are a woman of childbearing potential

Predictors of Cognitive Decline in Normal Aging
Sponsored by: National Institute on Aging (NIA)
ClinicalTrials.gov #: NCT00094939
Study Phase: Phase II

Study Location(s) and Contact Information
Center for Brain Health Silberstein Institute
New York University School of Medicine
New York, New York 10016
Kenneth E. Rich, 1.212.263.7563
kenneth.rich@med.nyu.edu

Study Purpose
This project plans to develop a test for diagnosing Alzheimer’s disease at an early stage. The procedure will use sophisticated brain imaging technology to monitor the loss of neurons and the reduction in brain size over time in people with Alzheimer’s.

You may qualify if you

• can be assessed as one of the following: cognitively normal, having mild cognitive impairment, having Alzheimer's disease, or having frontotemporal dementia
• are 60 to 80 years old
• reside in the New York City metropolitan area
• have a minimum of 12 years of education

• have a history of brain damage including significant trauma, stroke, hydrocephalus, seizures, or mental retardation
• have a history of alcoholism or drug abuse
• have schizophrenia or another psychiatric disorder
• have any prosthetic devices, such as pacemakers, that could be affected by the magnetic field employed during MRI imaging
• have uncontrolled high blood pressure or heart or vascular disorders
• have a history of familial early onset dementia

Implications of Amyloid Pathology
Sponsored by: National Institute on Aging (NIA)
ClinicalTrials.gov #: NCT00900770
Study Phase: Not applicable

Study Location(s) and Contact Information
Brigham and Women's Hospital
Boston, Massachusetts 02115
Kelly O'Keefe, 1.617.726.6212
kokeefe1@partners.org
Meghan Frey, 1.617.732.8085
mfrey1@partners.org

Study Purpose
This study hopes to learn more about the role of the protein fragment beta-amyloid in Alzheimer’s disease. Researchers will test whether people with high levels of beta-amyloid in their brains, but no cognitive symptoms of Alzheimer’s, will subsequently develop both cognitive impairment and the disease.

You may qualify if you

• are 60 to 90 years old

• have a diagnosis of mild cognitive impairment or dementia
• have an implanted metal pacemaker or other device that would prevent you from undergoing brain scans
• are taking medications that affect the central nervous system, including cholinesterase inhibitors, memantine, and antidepressants
• have schizophrenia or other psychiatric disorders
• have Huntington's disease
• have a head injury or significant seizures
• have cardiovascular disease, stroke, or congestive heart failure
• have had drug or alcohol abuse problems within the past 2 years
• have cancer or any other serious medical condition

Evolution of Memory Related Activity
Sponsored by: National Institute on Aging (NIA)
ClinicalTrials.gov #: NCT00902499
Study Phase: Not applicable

Study Location(s) and Contact Information
Two study locations in Boston
Meghan Frey, 1.617.732.8085
mfrey1@partners.org
Kelly O’Keefe, 1.617.726.6212
kokeefe1@partners.org

Study Purpose
This study will test whether refinements in functional magnetic resonance imaging (fMRI) technology can better detect the progression of Alzheimer’s disease and mild cognitive impairment (MCI). MCI is a disorder that often precedes Alzheimer’s. Researchers will use fMRI techniques to monitor the accumulation of beta-amyloid and other Alzheimer pathologies in participants’ brains over time.

You may qualify if you

• are 55 to 90 years old
• can be assessed as one of the following: cognitively normal, having mild cognitive impairment, or having Alzheimer’s disease

• have a neurological disorder other than Alzheimer’s or mild cognitive impairment
• have a history of depression or other psychiatric illness
• have a history of alcohol or drug abuse in the past 2 years
• have significant and uncorrectable vision impairment

Amyloid Plaque and Tangle Imaging in Aging and Dementia
Sponsored by: National Institute on Aging (NIA)
ClinicalTrials.gov #: NCT00355498
Study Phase: Not applicable

Study Location(s) and Contact Information
Jane & Terry Semel Institute for Neuroscience & Human Behavior
Los Angeles, California 90024
Andrea Kaplan, 1.310.825.0545
akaplan@mednet.ucla.edu
Deborah Dorsey, R.N., M.N., 1.310.825.0545
ddorsey@mednet.ucla.edu

Study Purpose
Two hallmarks of Alzheimer’s disease are 1) the accumulation of the protein fragment beta-amyloid into clumps called plaques and 2) the clumping of abnormal tau protein into tangles. Yet both of these protein formations also occur in the brains of normally aging people. This study aims to find ways of identifying aging, nondemented adults with plaques and tangles who are at greatest risk for developing Alzheimer’s.

You may qualify if you

• are 30 years of age or older
• have MCI or dementia and an available caregiver
• have vision and hearing that is adequate for compliance with testing procedures

• have cerebrovascular disease
• have a history of stroke, heart disease, uncontrolled hypertension, liver disease, diabetes, or cancer
• have a major psychiatric disorder
• are taking centrally active beta-blockers, narcotics, clonidine, anti-Parkinsonian medications, benzodiazepines, systemic corticosteroids, anti-convulsants, or warfarin
• have a current diagnosis or history of alcoholism or drug dependence
• have recently taken any investigational drugs
• have a pacemaker or other device that may prevent you from undergoing brain scans

Phase III Study of the Correlation Between Florpiramine F18 PET Imaging and Amyloid Pathology in the Brain
Sponsored by: Avid Radiopharmaceuticals
ClinicalTrials.gov #: NCT00857415
Study Phase: Phase III

Study Location(s) and Contact Information
Seven study locations around the United States
Michael J Pontecorvo, Ph.D., 1.215.966.6221
pontecorvo@avidrp.com
Christopher M Clark, M.D., 1.215.966.6123
clark@avidrp.com

Study Purpose
This study will test whether an imaging method called positron imaging tomography (PET) can accurately detect beta-amyloid levels in the brains of people with Alzheimer’s disease. Beta-amyloid is protein fragment and a key suspect in Alzheimer’s. The researchers will enroll fully consenting participants with Alzheimer’s disease that have a projected life expectancy of less than 6 months. They first will take PET scans of their participants and measure the brain beta-amyloid levels. After the participants’ death, measurements of each individual’s amyloid levels will be assessed from autopsied brain tissue. The researchers will then determine the accuracy of the earlier PET readings by comparing them against the readings taken at autopsy.

You may qualify if you

• have a projected life expectancy of 6 months or less
• are already enrolled in another longitudinal study of aging with an autopsy component
• can tolerate a 10-minute PET scan
• can give informed consent for study procedures and for brain donation

You may not qualify if you

• have a primary brain tumor, known brain metastases, or central nervous system lymphoma
• have loss of brain matter
• are being treated with chemotherapy or other life-sustaining measures
• have an infectious disease
• have participated in an investigational drug trial within the last 30 days
• have ever participated in an experimental study with a drug that targets beta-amyloid

Metabolic Cerebral Imaging in Incipient Dementia (MCI-ID)
Sponsored by: University of California, Los Angeles, Centers for Medicare and Medicaid Services
ClinicalTrials.gov #: NCT00329706
Study Phase: Not applicable

Study Location(s) and Contact Information
Six study locations in the United States
Erin Siu, Central Coordinator, 1.310.794.5067
erinsiu@mednet.ucla.edu
Daniel H Silverman, M.D., Ph.D., 1.310.825.4257
dsilver@ucla.edu

Study Purpose
This project will assess whether the imaging technique known as positron emission tomography (PET) can accurately distinguish people with preliminary Alzheimer’s disease from people who have developed other forms of cognitive impairment. PET scans can detect brain levels of beta-amyloid, a protein fragment associated with Alzheimer’s. The researchers hope that the PET techniques might be more effective at Alzheimer diagnosis than are traditional clinical practices.

You may qualify if you

• have a cognitive deficit and/or personality change
• are 65 years old or older

• have overt dementia
• have cognitive dysfunction that has impaired your ability to perform daily activities
• have a history of thyroid disease
• have a pacemaker or other device that would prevent you from undergoing brain scans
• have visual, auditory, or motor deficits that would prevent you from taking neuropsychological tests
• have already initiated cognitive therapy with cholinesterase inhibitors
• have a history of stroke, brain tumor, depression, substance abuse, malnourishment, heart disease, calcium imbalance, anemia, hypoxemia, thyroid dysfunction, kidney dysfunction, liver dysfunction, or diabetes