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CNS Tau Kinetics in Healthy Aging and Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT03938870
Recruitment Status : Recruiting
First Posted : May 6, 2019
Last Update Posted : May 6, 2019
Sponsor:
Collaborators:
BrightFocus Foundation
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
Alzheimer's disease (AD) is the most common cause of dementia and currently has no disease modifying treatments or simple accurate diagnostic tests. The goal of this project is to study how tau (a protein thought to cause AD) is made, transported and cleared in the human body. Better understanding of these processes may lead to improved understanding of AD, earlier diagnosis and a way to evaluate treatment.

Condition or disease Intervention/treatment
Alzheimer's Disease Brain Diseases Central Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Dementia Mental Disorders Nervous System Diseases Neurodegenerative Diseases Tauopathies Other: L-Leucine 13C6

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: CNS Tau Kinetics in Healthy Aging and Alzheimer's Disease
Study Start Date : August 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Leucine

Group/Cohort Intervention/treatment
Experimental: Group 1
30 Young Normal Controls(YNC) ages 18 & Older will enroll to evaluate leucine infusion methods of labeling, vs. the oral method. They will have 5 lumbar punctures (LPs) and the amount of labeled tau in the CSF will be analyzed to obtain tau kinetics in human central nervous system (CNS).
Other: L-Leucine 13C6
Experimental: Group 2
Group 30 CDR > 0. There will be collection of CSF and blood. The participants will either be labeled by intravenous infusion method with leucine or oral method based off the results from the Young Normal Control Group. They will have 5 lumbar punctures (LPs) and the amount of labeled tau in the CSF will be analyzed to obtain tau kinetics in human central nervous system (CNS).
Other: L-Leucine 13C6
Experimental: Group 3
Group of 40 CDR = 0 Age Matched. There will be collection of CSF and blood. The participants will either be labeled by intravenous infusion method with leucine or oral method based off the results from the Young Normal Control Group. They will have 5 lumbar punctures (LPs) and the amount of labeled tau in the CSF will be analyzed to obtain tau kinetics in human central nervous system (CNS).
Other: L-Leucine 13C6



Primary Outcome Measures :
  1. Tau kinetics in cerebrospinal fluid [half-life of tau], as assessed by tau stable isotope labeling kinetics (SILK) method [ Time Frame: 4 months ]
    To measure physiological tau kinetics with the tau SILK method in the CNS of human participants.


Secondary Outcome Measures :
  1. Age [ Time Frame: 4 months ]
    Physiological tau kinetics in CNS will be analyzed to determine the effects of age.

  2. Tau aggregation measured by PET Imaging [ Time Frame: 4 months ]
    Correlation between tau kinetics (SILK) measures [half-life of tau] and Tau PET Imaging results will be assessed.

  3. Amyloid aggregation measured by PET Imaging [ Time Frame: 4 months ]
    Correlation between tau kinetics (SILK) measures [half-life of tau] and Amyloid PET Imaging results will be assessed.


Biospecimen Retention:   Samples Without DNA
Plasma and Cerebrospinal Fluid


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

We will recruit 100 participants (age 18+) 30 Young Normal Controls, 30 AD participants (age 65+) and 40 age-matched controls (age 65+) to participate in this study. Studies will be conducted at the Clinical Trials Research Unit at Washington University School of Medicine. Volunteers will be screened for any major medical abnormalities, bleeding risks, or any other reason they might not tolerate the procedure.

The participants will either be labeled by intravenous infusion method or oral method. They will have 5 lumbar punctures (LPs) and the amount of labeled tau in the CSF will be analyzed to obtain tau kinetics in human central nervous system (CNS).

Criteria

Inclusion Criteria:

  1. Males or females of any race aged 18 or older
  2. No evidence of a neurologic disorder or traumatic head injury by history or examination
  3. Able to take food and drink by mouth safely
  4. Participants must be able to provide informed consent
  5. Absence of exclusion criteria

Exclusion Criteria:

  1. Requires tube feeding for nutrition and/or hydration
  2. Already on a special diet (e.g. Gluten free)
  3. History of bleeding disorder
  4. Allergy to Lidocaine
  5. Pregnancy
  6. Any contraindication for lumbar puncture e.g. blood thinners

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): NCT03938870


Contacts
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Contact: Melissa M Sullivan 314-747-4857 m.sullivan@wustl.edu
Contact: Melody Li, MS, OTR/L 314-273-6062 slia@wustl.edu

Locations
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United States, Missouri
Washington University in Saint Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Melissa M Sullivan    314-747-4857    m.sullivan@wustl.edu   
Contact: Melody Li, MS, OTR/L    314-273-6062    slia@wustl.edu   
Principal Investigator: Randall Bateman, MD         
Sponsors and Collaborators
Washington University School of Medicine
BrightFocus Foundation
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Randall Bateman, MD Washington University in Saint Louis

Publications of Results:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03938870     History of Changes
Other Study ID Numbers: 201502091
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Washington University School of Medicine:
Alzheimer's Disease
Alzheimer's
biomarker
dementia
Tau
Tau Kinetics
Tauopathies

Additional relevant MeSH terms:
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Dementia
Disease
Alzheimer Disease
Delirium
Mental Disorders
Psychotic Disorders
Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Central Nervous System Diseases
Cognition Disorders
Tauopathies
Neurocognitive Disorders
Pathologic Processes
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Schizophrenia Spectrum and Other Psychotic Disorders