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PET Measures of CSF Clearance in Preclinical Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663387
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : March 10, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
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.

Condition or disease
Mild Cognitive Impairment

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PET Measures of CSF Clearance in Preclinical Alzheimer's Disease
Actual Study Start Date : July 30, 2018
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Group/Cohort
Normal subjects
70



Primary Outcome Measures :
  1. Percent change in brain amyloid [ Time Frame: Baseline and 24 Months follow-up ]
    Percent change in brain amyloid measured by positron emission tomography

  2. Percent change in cortical ribbon thickness [ Time Frame: Baseline and 24 Months follow-up ]
    Percent change in cortical ribbon thickness measured by magnetic resonance imaging


Biospecimen Retention:   None Retained
Blood incl. geneting testing/APE Genotyping, CSF


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study will involve male and female volunteer subjects from any racial or ethnic group with a diagnosis normal cognition. The base clinical cohort uses the same diagnostic inclusion and exclusion criteria for NL subjects as the NIHADNI protocol. The proposed sample is not intended to be representative of a general population, but it will approximate the samples recruited in NIH and industry sponsored FDA approved clinical trials targeting secondary AD prevention. At this stage of knowledge of human brain CSF clearance, a population based approach was considered premature and over cap funding to support a larger study was not permitted for RFA AG-17-055. Rather, our design uses Aβ enrichment to enable an efficient test of the CSF clearance hypothesis in a clinically relevant group.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663387


Contacts
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Contact: Patrick Harvey, MA 646-962-8508 PAH2018@med.cornell.edu

Locations
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United States, New York
Weill Cornell Medicine Recruiting
New York, New York, United States, 10021
Contact: Patrick Harvey    646-962-8508    pah2018@med.cornell.edu   
Principal Investigator: Mony De Leon, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Mony J de Leon, ED.D. Weill Cornell Medicine
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03663387    
Other Study ID Numbers: 1804019181
1RF1AG057570-01 ( U.S. NIH Grant/Contract )
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial, after deidentification.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be made available through the Brain Health Imaging Institute at Weill Cornell Medicine through correspondence with mdl4001@med.cornell.edu
Access Criteria: Anyone who wishes to access the data who will provide a methodologically sound proposal.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders