Our projects range from non-invasive, observational studies to traditional clinical trials.
Clinical Drug Trials
AbbVie AWARE-Tau Antibody
The study is designed to examine the safety & efficacy of a drug, ABBV-8E12, that targets the protein tau in the brains of people with Alzheimer’s Disease. Research has shown that cognitive decline in patients with Alzheimer’s disease may relate to levels of abnormal tau protein in their brains. Findings from this study may help us prevent or treat Alzheimer’s Disease by blocking the spread of tau protein in the brain.
This study will evaluate the safety and tolerability of efavirenz (EFV) in subjects with clinically stable mild cognitive impairment and early dementia due to Alzheimer’s Disease. Additional primary objectives include an evaluation of whether EFV can affect cholesterol metabolism and increase excretion of excess cholesterol, which can impact systems in the brain related to memory and learning performance.
EIP p38 MAPK
The purpose of this study is to examine the safety and efficacy of an experimental compound, Neflamapimod, in volunteers with Mild Cognitive Impairment or Mild Alzheimer’s Disease. We will be looking for changes that can be seen in the blood, in the fluid that surrounds the brain, and in memory and cognitive performance. We hope that the findings from this study may help us find better ways to treat Alzheimer’s Disease.
The study aims to evaluate the safety, tolerability, and target engagement of AMX0035 in subjects with mild cognitive impairment or probable Alzheimer’s Disease. Additional goals of the study include analyzing changes that can be seen in the blood, brain imaging, and fluid which surrounds the brain in order to better the efficacy of AMX0035 as a potential treatment for neurodegenerative dementia.
Observational Research Studies
The purpose of this research is to test and retest the reliability of autonomic measures such as heart rate variability and galvanic skin response in cognitively normal adults and adults diagnosed with probable Alzheimer's Disease (AD), Frontotemporal Dementia (FTD) or Dementia with Lewy Bodies (DLB). We will also evaluate Anxiety, Irritability and Agitation (AIA) symptoms in this population as they relate to autonomic dysfunction and disease progression.
Genetic Prion Disease Biomarker Study
The study is designed to examine quantitative biomarkers that may help direct future clinical trials for Prion disease treatment and therapy by gathering data on prion protein levels in cerebrospinal fluid (CSF) and how levels vary over time. This is done in order to understand how well we could measure a drug-dependent reduction for future clinical drug trials.
LifeSPAN Biobank Study
The goal of the LifeSPAN biobanking study is to establish a robust collection of samples from individuals spanning the spectrum of aging and cognition, including normal cognition, mild cognitive impairment, and dementia. Samples, including blood and cerebrospinal fluid, will be stored and used mainly for research on a variety of neurodegenerative diseases. We hope that this study may aid in finding disease markers to diagnose or follow different types of neurologic conditions.
Alzheimer’s Disease is generally defined by the presence of amyloid plaques in the brain, which are large deposits of insoluble amyloid protein. However, there are a significant number of individuals who have large numbers of amyloid plaques in their brain, but no cognitive problems. In this project we use proteomics and immunohistochemistry to study post-mortem brain tissue from these individuals, and try to define what makes an individual resilient to cognitive impairment.
CMP3 CSF Multiple PathoPhysiology Panel
The CMP3 panel is a highly curated, novel collection of commercially available ELISA kits that accurately quantify proteins related to biological pathways that are often associated with Alzheimer’s Disease such as oxidative stress, inflammation, and metabolism. We aim to use this panel to classify individuals and direct them towards appropriate clinical trials, and to directly monitor how effectively the treatment is targeted. You can read Bianca’s paper on development of the CMP3 here: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0193707
Individuals with Alzheimer’s Disease share many of the age-related problems that occur with type 2 diabetes, including insulin resistance, disrupted glucose metabolism and oxidative and inflammatory stress. Having type 2 diabetes greatly increases the risk of developing Alzheimer’s Disease. As part of a collaborative project, ACTRU is looking at the key proteins involved in the regulation of insulin signaling in the brain, their activity, and how they may contribute to Alzheimer’s Disease susceptibility and progression.
MADRC Biomarker Core
As the MADRC biomarker core, ACTRU collects, stores and distributes biofluids from subjects who have consented to donation for research use. The MADRC biomarker core performs routine quantification of core Alzheimer’s Disease markers (Ab42, total Tau and pT181 Tau) in all collected cerebrospinal fluid (CSF), and is developing ultra-sensitive methods for their quantification in plasma. In addition to these central functions, ACTRU advises researchers on all aspects of biofluid research from sample collection to sample analysis, and is building biomarker panels that assess other biological pathways affected by Alzheimer’s Disease.
RISE-Delirium CSF Biomarker
The RISE study (Role of Inflammation after Surgery in Elders) seeks to understand the effect of neuroinflammatory pathways in post-operative delirium and cognitive decline. Its goal is to verify novel biomarkers of neuroinflammation and evaluate their potential as therapeutic targets. This is accomplished by studying cerebrospinal fluid and blood proteins before and after elective orthopedic surgery. Since delirium occurs following major physiologic disruptions such as medical illness and surgery, these operations present a unique window to study and intervene upon the cognitive trajectory of older adults.