Diagnostics, Imaging, And Genetics Network for the Objective Study and Evaluation (DIAGNOSE) of Chronic Traumatic Encephalopathy (CTE)

This study is looking to develop diagnostic criteria for CTE. Dr. Stern is the contact PI (other PI’s are J. Cummings, E. Reiman, and M. Shenton) of this $16 million, multi-center, multi-disciplinary, 7-year grant to further his initial work on the development of in vivo biomarkers for CTE and clinical diagnostic criteria. This study is funded by the NIH/ NINDS and will begin recruitment in Summer 2016. Former NFL players, former college football players, and “control” participants between the ages of 45 and 74 will be recruited for examinations to be held at one of four locations (Boston, New York, Las Vegas, Scottsdale/Pheonix).

CURRENTLY ENROLLING: Learn how to participate HERE or contact Taylor Platt at diagnose@bu.edu or 617-358-6562

Click HERE to visit the DIAGNOSE CTE Research Project website

Longitudinal Examination to Gather Evidence of Neurodegenerative Disease

The study focuses on examining the effects of repetitive head impacts (like one may receive playing some organized sports) in living people. Participants complete online questionnaires and talk with a member of our study staff once a year over the phone so we may gather information on concussions, athletic history, medical history, and cognitive functioning. Participants can also choose to provide a saliva sample for genetic analysis. The goal is to track our participants’ progress over time, so we can see who develops problems down the road and who does not.

CURRENTLY ENROLLING: Learn how to participate HERE or contact the LEGEND Study at LEGEND@bu.edu or 617-414-8389

Learn more HERE

Diagnosing and Evaluating Traumatic Encephalopathy using Clinical Tests

THIS STUDY IS COMPLETE

This study was the first research project on CTE ever funded by the National Institutes of Health (NIH), with support from the National Institute of Neurologic Diseases and Stroke (NINDS), the National Institute on Aging (NIA), and the National Institute of Child Health and Human Development (NICHD). The ultimate goal of this study was to develop methods of diagnosing CTE during life through the use of a variety of tests, including MRI scans (such as diffusion tensor imaging), MRS scans (also known as a “virtual biopsy”), blood tests, and measures of proteins in spinal fluid. Participants also underwent neurological, psychiatric, and cognitive assessments, as well as genetic testing.

Click HERE for published journal articles

The A4 study was designed to evaluate safety, tolerability and efficacy of Solanezumab in older individuals who have normal thinking and memory function but who may be at risk for developing dementia related to Alzheimer’s disease (AD) in the future. The A4 study aims to evaluate whether a new investigational treatment can slow the memory loss caused by Alzheimer’s disease. The overall goal of the A4 study is to test whether decreasing amyloid with antibody investigational treatment can help slow the memory loss associated with amyloid buildup in some people.

Learn about enrolling HERE

Visit the study website HERE

Contact Nicole Gullotti at ngullott@bu.edu

(Health Outreach Program for the Elderly)

The HOPE Study is the flagship research project of the BU Alzheimer's Disease and CTE Center, funded by the National Institute on Aging (NIA). It is a longitudinal study designed to help us improve our understanding of how memory and other thinking abilities change in people as they age, evaluating persons with and without memory problems throughout their lives. The HOPE study also serves as a registry of research participants to help other researchers who are studying normal aging and Alzheimer’s disease. The results of the study provide valuable information that will assist researchers who are working toward finding causes and treatments for Alzheimer’s disease and related memory impairment.

Learn about enrolling HERE or contact Nicole Gullotti at: ngullott@bu.edu

Visit the study website HERE

The purpose of this study is to examine the response to and clinical efficacy of a new drug, "BAN2401", in subjects with Early Alzheimer’s Disease. During this 18-month study, 3 different dose levels are given biweekly to separate groups of subjects and 2 dose levels are given monthly to separate groups of subjects. The 2 clinical subgroups are subjects with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s Disease dementia. This is a placebo-controlled, double-blind, parallel-group study.

Enrollment Closed

Visit the study website HERE

Contact Nicole Gullotti at:  ngullott@bu.edu

This longitudinal and cross-sectional study is designed to evaluate the safety and imaging characteristics of 18F-AV-1451 in cognitively healthy volunteers, subjects with Mild Cognitive Impairment (MCI), and subjects with Alzheimer’s Disease (AD). 18F-AV-1451 is a brain imaging agent used in PET (Positron Emission Tomography) Scans. Cognitively healthy participants receive an IV injection of Florbetapir, which is also a PET scanning compound used as a diagnostic tool for Alzheimer’s. Cross-sectional and longitudinal participants will receive a single dose injection of 18F-AV-1451. Only longitudinal participants will receive an IV injection of 18F-AV-1451 at 9 and 18 months. Exploratory MCI Subjects will receive an IV injection of Florbetapir at baseline, followed by an IV injection of 18F-AV-1451 at baseline, 9 months, and 18 months. 

Learn about enrolling HERE

Visit the study website HERE

Contact Nicole Gullotti at: ngullott@bu.edu

This purpose of this clinical trial is to test the idea that Solanezumab can be used as a neuroprotector to slow the cognitive and functional decline if Alzheimer’s Disease. Solanezumab is an antibody directed against the mid-domain of the harmful, AD-causing A-beta peptide. Participants with Mild Alzheimer’s Disease will be given either Solanezumab every 4 weeks for 18 months, or a Placebo every 4 weeks for 18 months. The drugs are administered intravenously (IV). There is then an additional 4 weeks of assessment. 

Enrollment Closed

Visit the study website HERE

Contact Nicole Gullotti at: ngullott@bu.edu

This clinical trial is examining the effects of an oral medication on those with mild to moderate Alzheimer's disease currently on Aricept (Donepezil). The medication, "T-817MA" is designed to potentially treat Alzheimer’s disease by protecting brain cells. The drug is undergoing phase two trials in which it is being tested in patients with mild to moderate Alzheimer’s disease. Participants are given either T-817MA or placebo over a 14 month period. People participating in the trial will undergo various physical and cognitive tests with an MRI scan completed at the beginning and end of the study. Primary care doctors are kept informed about participant progress and lab results, and the participants receive regular health checks by professionals that specialize in Alzheimer’s disease. 

Enrollment Closed

Visit the study website HERE

Contact Nicole Gullotti at: ngullott@bu.edu

The DAYBREAK-ALZ Study is a clinical research study in mild Alzheimer's disease. We are looking for people who would like to participate.

The Study will examine an oral investigational drug that may have some effect on the brain changes associated with Alzheimer's disease/ The study is designed to find outwhether this investigational drug (or "study drug") can slow down the decline in memory and mental functioning. "Investigational" means that the drug is still being evaluated in clinical studies, and has not yet been approved for use by doctors in their everyday practice.

The DAYBREAK-ALZ study will include approximately 1,900 participants from around the globe.

Learn more about about DAYBREAK-ALZ HERE

To learn more about enrollment contact Nicole Gullotti at: ngullott@bu.edu

The purpose of this test is to determine a score for the Rey-Osterrieth Complex Figure (ROCF) evaluation. ROCF is an evaluation that tests multiple cognitive abilities by asking participants to sketch a given line drawing first while seeing the drawing and then solely from memory.  This test can be administered to participants between the ages of 18-94 and generally require a duration of 45 minutes. According to Psychological Assessment Resources (PAR), this test has been determined to “successfully discriminate between individuals with known traumatic brain injury and those without.” 

The purpose of this test is to evaluate a multitude of different cognitive skills and functions. Development of NAB stretched over a 7 year period and was partly funded by the National Institute of Mental Health. NAB can be administered to participants ranging in age from 18-97 years old. The overall administration time depends on the specific module and test being administered, but in its entirety, NAB can generally be completed in less than four hours. Additionally, the scoring time for NAB is roughly 75 minutes. NAB can be found through Psychological Assessment Resources (PAR). 

The purpose of this test is to assess the moods of adults suffering from neurological impairments, who are in either medical or psychiatry settings. This test can be administered by either an individual or a group. Adults ranging from the ages of 18-94 can undergo testing. The test generally takes a total of 15 minutes, 5 minutes for administration and 10 minutes for scoring. This test can be found through Psychological Assessment Resources (PAR). 

The A4 study was designed to evaluate safety, tolerability and efficacy of Solanezumab in older individuals who have normal thinking and memory function but who may be at risk for developing Alzheimer’s disease (AD) memory loss sometime in the future. The A4 study aims to evaluate the whether a new investigational treatment can slow the memory loss caused by Alzheimer’s disease. The overall goal of the A4 study is to test whether decreasing amyloid with antibody investigational treatment can help slow the memory loss associated with amyloid buildup in some people.

Visit the study website HERE

Closed to Enrollment

The purpose of this study is to examine the response to and clinical efficacy of a new drug called "BAN2401" from subjects with Early Alzheimer’s Disease. During this 18-month study, 3 different dose levels are given biweekly to separate groups of subjects and 2 dose levels are given monthly to separate groups of subjects. The 2 clinical subgroups are subjects with mild cognitive impairment (MCI) due to Alzheimer’s disease or mild Alzheimer’s Disease dementia. This is a placebo-controlled, double-blind, parallel-group study.

Visit the study website HERE

Closed to Enrollment

This longitudinal and cross-sectional study is designed to evaluate the safety and imaging characteristics of 18F-AV-1451 in cognitively healthy volunteers, subjects with Mild Cognitive Impairment (MCI), and subjects with Alzheimer’s Disease (AD). 18F-AV-1451 is a brain imaging agent used in PET (Positron Emission Tomography) Scans. Cognitively healthy participants receive an IV injection of Florbetapir, which is also a PET scanning compound used as a diagnostic tool for Alzheimer’s. Cross-sectional and longitudinal participants will receive a single dose injection of 18F-AV-1451. Only longitudinal participants will receive an IV injection of 18F-AV-1451 at 9 and 18 months. Exploratory MCI Subjects will receive an IV injection of Florbetapir at baseline, followed by an IV injection of 18F-AV-1451 at baseline, 9 months, and 18 months.

Visit the study website HERE

Closed to Enrollment

This purpose of this clinical trial is the test the idea that Solanezumab can be used as a neuroprotector to slow the cognitive and functional decline if Alzheimer’s Disease. Solanezumab is an antibody directed against the mid-domain of the harmful, AD-causing A-beta peptide. Participants with Mild Alzheimer’s Disease will being be given either Solanezumab every 4 weeks for 18 months, or a Placebo every 4 weeks for 18 months. The drugs are administered intravenously (IV). There is then an additional 4 weeks of assessment.

Visit the study website HERE

Closed to Enrollment

This clinical trial is examining the effects of an oral medication on those with mild to moderate AD currently on Aricept (Donepezil). The medication, "T-817MA" is designed to potentially treat Alzheimer’s disease by protecting brain cells. The drug is undergoing phase two trials in which it is being tested in patients with mild to moderate Alzheimer’s disease. Participants are given either T-817MA or placebo over a 14 month period. People participating in the trial will undergo various physical and cognitive tests with an MRI scan completed at the beginning and end of the study. Primary care doctors are kept informed about participant progress and lab results, and the participants receive regular health checks by professionals that specialize in Alzheimer’s disease.

Visit the study website HERE

Closed to Enrollment