New York, New York 10016


Purpose:

The purpose of this study is to measure cerebrospinal fluid (CSF) clearance. CSF cushions the brain from impact and carries waste products from the brain to the bloodstream. This process is known as clearance. Researchers have considered that impaired clearance of amyloid (a protein) from the aging brain causes buildup of amyloid in the brain and plays a role in increased risk for Alzheimer's disease. However, until recently, there has not been a method to measure CSF clearance. This study will examine CSF clearance using positron emission tomography (PET) scanning, which creates images of structures in the body and their functioning. This study will also measure the amount of two proteins, tau and amyloid, in the brain. Tau and amyloid are proteins that build up in the brains of people with Alzheimer's disease. An investigational compound (tracer) called [18F]MK-6240 is injected into the blood prior to the scan in order to take images of the CSF clearance and measure tau protein in the brain. This tracer is considered investigational because it is not approved by the US Food and Drug Administration (FDA) for clinical use and is only being used for research purposes.


Criteria:

Inclusion Criteria: - Male and female subjects between 40-85 years old will be enrolled. Younger subjects are not included as the risk for brain amyloid lesions is too low - All subjects will speak English as their first language or demonstrate proficiency in English (defined as reaching a scaled score of > 11 on the WAIS vocabulary test). - All subjects will have normal cognition at baseline: a Clinical Dementia Rating CDR=0, Global Deterioration Scale GDS<2. - All subjects will be in good general health and able to participate in the LP and imaging exams. This determination is made by the study neurologist and reviewed at a consensus meeting for each subject. Exclusion Criteria: - Uncontrolled hypertension or metabolic disease - Neurodegenerative disorders (i.e. Parkinson disease. LBD, or FTD). - Dementia or Mild cognitive impairment at baseline - Long life major depression. Baseline scores ≥16 on the 17-item Hamilton Depression Scale at baseline. - Long-life DSM-IV axis 1 disorders. - Mental retardation. - Substance abuse. - Concurrent medication limiting validity of neuropsychological tests or imaging. - Anti-depressants with anti-cholinergic properties - Monoamine oxidase inhibitors (MAOi) - Regular use of narcotic analgesics (>2 doses per week). - Use of neuroleptics - Use of anti-dementia medications (Aricept, Exelon, Razadyne) and memantine (Namenda)) or anti-Parkinsonian medications (Sinemet, amantadine, bromocriptine, pergolide, selegeline). - Individuals taking over the counter memory enhancing or protecting medications (e.g. ginkgo biloba, vitamins) are not excluded. - Implanted medical devices that are incompatible with MRI imaging. - Radiation exposures exceeding annual Rad Worker limits. - Heart failure stage D as defined by American Heart Association (7). - Chronic kidney disease in stages ≥ 4, as defined per National Kidney Foundation (8). - Brain tumor and other neoplastic disorders outside the brain where disease itself or its treatment (radiation, chemotherapy) is likely to affect brain structure or function. - Stroke when meeting criteria for total anterior, partial anterior or posterior circulation infarct according to the Oxford Community Stroke Project classification. Patients with clinically silent of lacunar strokes and transient ischemic attacks will not be excluded. - Significant head trauma. - Hydrocephalus. - Hostility or refusal to cooperate


NCT ID:

NCT03663387


Primary Contact:

Principal Investigator
Mony De Leon
New York University School of Medicine

Patrick Harvey
Phone: 212.263.7563
Email: patrick.harvey@nyumc.org


Backup Contact:

N/A


Location Contact:

New York, New York 10016
United States

Patrick Harvey
Phone: 212-263-7563
Email: patrick.harvey@nyumc.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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