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Cerebrospinal Fluid Clearance in Preclinical Alzheimer's Disease

Recruiting

This clinical trial will use positron emission tomography (PET) scanning to measure the clearance of waste from the brain via cerebrospinal fluid. The objective is to determine the role of impaired clearance in the buildup of the amyloid protein in the aging brain and risk for Alzheimer's disease. A harmful form of amyloid is seen in the brains of people with Alzheimer's.

Minimum Age Maximum Age Gender Healthy Volunteers
40 Years 85 Years All Accepts Healthy Volunteers
July 30, 2018
June 2022
136

  • English as a first language or proficient in English (score of >11 on the WAIS vocabulary test)
  • Normal cognition (Clinical Dementia Rating =0, Global Deterioration Scale <2)
  • Good general health

  • Uncontrolled high blood pressure or metabolic disease
  • Neurodegenerative disorders (i.e., Parkinson's disease, Lewy body dementia, frontotemporal disorders)
  • Dementia or mild cognitive impairment
  • Lifelong major depression; lifelong DSM-IV Axis 1 disorders
  • Mental retardation
  • Substance abuse
  • Prohibited medications:
    • Medications limiting validity of neuropsychological tests or imaging
    • Antidepressants with anticholinergic properties
    • Monoamine oxidase inhibitors 
    • Regular use of narcotic analgesics (more than twice per week)
    • Neuroleptics
    • Alzheimer's medications (Aricept, Exelon, Razadyne, Namenda)
    • Parkinsonian medications (Sinemet, amantadine, bromocriptine, pergolide, selegeline)
    • Participants are not excluded for using over-the-counter memory-enhancing or -protecting medications, such as ginkgo biloba or vitamins
  • Implanted medical devices incompatible with magnetic resonance imaging imaging
  • Heart failure stage D as defined by the American Heart Association
  • Chronic kidney disease in stage 4 or greater as defined by the National Kidney Foundation
  • Brain tumor and other neoplastic disorders outside the brain where disease itself or its treatment (e.g., radiation, chemotherapy) is likely to affect brain structure or function
  • Major stroke
  • Significant head trauma
  • Hydrocephalus

In a process known as clearance, cerebrospinal fluid carries waste products from the brain to the bloodstream. Researchers seek to measure whether impaired clearance of amyloid from the brain causes amyloid to build up and increase the risk for Alzheimer's disease. Researchers will examine cerebrospinal fluid clearance using PET scans with an investigational tracer, [18F]MK-6240. The study will measure the level of two proteins, amyloid and tau, in the brain. Participants will also undergo a lumbar puncture.

Name City State Zip Status Primary Contact
New York University School of Medicine
New York New York 10016 Recruiting Patrick Harvey
212-263-7563
patrick.harvey@nyumc.org

New York University School of Medicine

Name Role Affiliation
Mony De Leon Principal Investigator New York University School of Medicine

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

NCT03663387

PET Measures of CSF Clearance in Preclinical Alzheimer's Disease