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New York University Clinical Trials
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Research Opportunities 

Longitudinal Study of Normal Aging, Mild Cognitive Impairment (MCI) and Alzheimer’s Disease 
Participants receive a comprehensive diagnostic evaluation and are reevaluated every year. The goal is to improve early diagnosis and better understand the clinical course and causes of age-related cognitive decline and AD. For information, call Thet Oo at 212-263-8088; thet.oo@nyumc.org 

TREATMENT STUDIES 

Memantine (Namenda) and Individualized Alzheimer’s Care 
The goal of this 1 year study for middle or late stage AD is to determine the added value of an individualized patient management program in patients receiving Memantine. All patients receive Memantine and follow-up evaluations and are randomly assigned to a group receiving compensation or a group receiving an individualized program consisting of caregiver training and support as well as home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation. For information, call Sunnie Kenowsky at 212-263-7164; sunnie.kenowsky@nyumc.org

Rivastigmine prophylaxis for elderly patients at risk for delirium: A randomized, double blind placebo-controlled pilot study
The goal is to assess the effectiveness of Rivastigmine, a long central acting acetylcholinesterase inhibitor commonly used to treat AD and other dementias, on the prevention of postoperative delirium (POD-changes in consciousness and cognition over a brief period of time ) and postoperative cognitive dysfunction (POCD-cognitive problems involving memory, learning and the ability to concentrate observed weeks or months after surgery) in an elderly population undergoing surgery. Subjects over age 65 will receive a brief series of evaluations of their cognitive and memory function. For information, contact Andrew Sapson, MD at 212- 263-0667. 

Early AD Diagnosis 

Clinical Correlates of Longitudinal PET Changes in Alzheimer’s Disease
The goal is to assess combining FDG-PET imaging (brain metabolism) with cerebrospinal fluid (CSF) biomarkers and PET amyloid imaging (using a tracer that binds to brain amyloid) in predicting cognitive decline. We are enrolling mild AD, MCI and normal subjects over age 20 who receive a comprehensive evaluation: neurological/physical exam, MRI and PET, memory testing, laboratory blood-work, EKG and lumbar puncture. Participants receive results and are compensated for their time and effort. For more information, call 212-263-7795; megan.cummings@nyumc.org.

Maternal History of Alzheimer Predisposes Children to Brain Hypometabolism 
The goal is to determine whether young subjects (age 20- 60) with maternal family history of AD show reductions in the brain’s ability to use sugar, and to see if there are greater reductions in subjects with family history spanning 2 generations (i.e., mother and grandmother affected with AD). For more information, contact John Murray at 212-263-7795; john.murray@nyumc.org

Effects of Memantine on Magnetic Resonance Spectroscopy in persons at risk for AD 

This study is for adults 55-90 with memory complaints and a family history of AD, but without any signs of memory decline. We are testing whether Memantine, a drug approved for the treatment of moderate to severe AD, may be beneficial in these at risk individuals. The study duration is 6 months. The brain effects of memantine are measured with magnetic resonance spectroscopy (MRS), a scan to investigate in the chemical substances that make up the brain. For information, call Lidia Glodzik at 212-263-5698; lidia.glodzik@nyumc.org.

Imaging Neuroinflammation in Alzheimer’s Disease with [11C]Arachidonic Acid (AA) and PET
 
The goal is to validate a new inflammation PET imaging agent known as [11C] Arachidonic Acid (AA) in individuals with and without cognitive dysfunction. Inflammation is a key component of the pathological processes (amyloid beta plaque deposition, neurofibrillary tangles, neuronal loss, astrocytosis) that are found in patients with Alzheimer disease (AD). An in vivo neuroimaging method to measure markers of neuroinflammation would represent a major advance in the understanding of the pathophysiology of AD and other dementing disorders. We are enrolling normal and dementia subjects over the age of 65 who receive physical examination, blood tests, neuropsychological evaluation, EKG, MRI; [11C]PIB, [18F]FDG, and [11C] AA PET scans. Participants receive results and are compensated for their time and effort. For information, contact Ricardo Osorio at 212-263-3258; Ricardo.osorio@nyumc.org

MRI Progression Markers of Cognitive Decline in the Elderly 

This project investigates the relationship between plasma amyloid beta protein levels and brain vascular response to CO2 (measured with MRI). Additional tests include brain structure measurement and CSF tau levels. Participants should have mild cognitive impairment (MCI), and will receive a comprehensive evaluation consisting of a neurological/physical examination, neuroimaging (MRI and ASL), memory testing, laboratory blood-work, ECG and lumbar puncture. Participants receive results and are compensated for their time and effort. For information, contact Vanessa Bikhazi at 212- 263-7563; vanessa.bikhazi@nyumc.org.

Biomarkers in Early Alzheimer’s Disease

This project builds upon on our new work demonstrating the value of cerebrospinal fluid (CSF) and blood biomarkers. We combined these analyses with novel MRI technology which looks at cerebral blood flow, a possible mechanism-based marker for early Alzheimer’s disease. We are enrolling normal subjects over the age of age 50, with and without mild memory complaints to receive a comprehensive evaluation: neurological/physical exam, MRI and memory testing, laboratory blood-work, EKG and lumbar puncture. Participants receive results and are compensated for their time and effort. For information, contact Vanessa Bikhazi at 212-263- 7563; vanessa.bikhazi@nyumc.org

Aß42 CSF changes in elders with sleep disorders. A new risk factor for AD? 

Sleep is involved in brain restoration and modulation of memory. The goal of our study is to analyze if the production of amyloid is disrupted by sleep/wake changes that occur during normal aging, and exacerbated in older subjects with sleep disorders, increasing the risk for developing AD. For this purpose, we plan to conduct clinical examinations, objective evaluation of sleep duration and quality using an actigraph, sleep breathing using and ARES Unicorder and CSF measurements. We are enrolling cognitively normal subjects ages 60-85 with chronic sleep disorders and subjects with normal sleep. This project will provide us with very useful information about Aß metabolism in the elderly and of certain patterns of sleep disorders as potential risks factors for developing AD. This finding, given the effect of sleep disorders in our lives, the increasing numbers of cognitively impaired elders, and the fact that millions of people regularly obtain insufficient sleep, would be of the highest relevance. For information, contact Ricardo Osorio at 212-263- 3258; Ricardo.osorio@nyumc.org.

Postoperative cognitive decline, inflammation, and plasma levels of betaamyloids
 
The goal of this study is to examine whether inflammation associated with surgery may increase the risk of postoperative cognitive dysfunction (POCD) in elderly patients who already have a degree of preoperative mild cognitive impairment (MCI). Inflammatory mechanisms may also be involved with the progression of Alzheimer’s Disease. POCD is a potential complication that may have consequence for patients’ quality of life. This is the first prospective study to attempt to establish this link. We are enrolling MCI and normal subjects over age 65 who receive a series of comprehensive evaluations of cognitive and memory functioning as well as laboratory blood-work. Timing is important so please let us know if you are planning to have surgery. Participants are compensated for their time and effort. For information, contact 212-263-0531. 


 

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