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Neuroimaging in Healthy Aging and Senile Dementia (HASD IND) (HASD PIB IND)

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: NCT04579120
Recruitment Status : Not yet recruiting
First Posted : October 8, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Tammie L. S. Benzinger, MD, PhD, Washington University School of Medicine

Brief Summary:

The purpose of this research study is to evaluate the structure and function of the brain in healthy aging and early Alzheimer's disease using positron emission tomography (PET), magnetic resonance imaging (MRI), and computed tomography (CT) imaging. The study involves imaging the brain to detect the presence of amyloid deposits (plaques in the brain). Amyloid is a protein that may be related to dementia of Alzheimer's disease (DAT).

This study will use radioactive tracers called C-11 Pittsburgh Compound B (PIB) and F 18/ AV-1451 (Flortaucipir) which binds to beta amyloid and tau in the brain. These compounds are considered investigational, which means that they have not been approved by the United States Food and Drug Administration (FDA).


Condition or disease Intervention/treatment
Alzheimer Disease Drug: [11C]-Pittsburgh Compound B ([11C]PiB) Drug: F 18 AV-1451 (Flortaucipir)

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Study Type : Observational
Estimated Enrollment : 650 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Neuroimaging in Healthy Aging and Senile Dementia (HASD IND)
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : December 2025


Group/Cohort Intervention/treatment
African American
African American participants receiving [11C]-Pittsburgh Compound B ([11C]PiB) F 18 AV-1451 (Flortaucipir) for imaging.
Drug: [11C]-Pittsburgh Compound B ([11C]PiB)
A dosage range between 6.0 - 20.0 mCi (222-740 MBq) is planned for [11C] PIB. A PET-certified medical professional will prepare and administer the [11C] PIB tracer. Prior to the administration, the dosage will be assayed in a dose calibrator and diluted with 0.9% sodium chloride (normal saline) up to a total 20 mL syringe volume. Participants will receive a maximum intravenous bolus injection of 20.0 mCi of [11C] PIB followed by a 10 mL 0.9% sodium chloride (normal saline) flush.
Other Name: PiB

Drug: F 18 AV-1451 (Flortaucipir)
A dosage range between 6.5 - 10.0 mCi (240-370MBq) is planned for [18F] AV-1451. A PET-certified medical professional will prepare and administer the [18F] AV-1451tracer. Prior to the administration, the dosage will be assayed in a dose calibrator. The volume of 18F-AV-1451 dose should not be adjusted by adding normal saline to the syringe. Participants will receive a maximum intravenous bolus injection of 10.0 mCi of [18F] AV-1451 followed by a 10 mL flush of 0.9% sodium chloride (normal saline).
Other Name: F 18 AV-1451

Non-Hispanic White
Non-Hispanic White participants receiving [11C]-Pittsburgh Compound B ([11C]PiB) F 18 AV-1451 (Flortaucipir) for imaging.
Drug: [11C]-Pittsburgh Compound B ([11C]PiB)
A dosage range between 6.0 - 20.0 mCi (222-740 MBq) is planned for [11C] PIB. A PET-certified medical professional will prepare and administer the [11C] PIB tracer. Prior to the administration, the dosage will be assayed in a dose calibrator and diluted with 0.9% sodium chloride (normal saline) up to a total 20 mL syringe volume. Participants will receive a maximum intravenous bolus injection of 20.0 mCi of [11C] PIB followed by a 10 mL 0.9% sodium chloride (normal saline) flush.
Other Name: PiB

Drug: F 18 AV-1451 (Flortaucipir)
A dosage range between 6.5 - 10.0 mCi (240-370MBq) is planned for [18F] AV-1451. A PET-certified medical professional will prepare and administer the [18F] AV-1451tracer. Prior to the administration, the dosage will be assayed in a dose calibrator. The volume of 18F-AV-1451 dose should not be adjusted by adding normal saline to the syringe. Participants will receive a maximum intravenous bolus injection of 10.0 mCi of [18F] AV-1451 followed by a 10 mL flush of 0.9% sodium chloride (normal saline).
Other Name: F 18 AV-1451




Primary Outcome Measures :
  1. AD Biomarkers seen on Amyloid PET at Baseline and Years 1, 2, and/or 3 [ Time Frame: 5 years ]
    This Project aims to identify factors that signal the transition from asymptomatic (preclinical) to symptomatic Alzheimer disease (AD). This will be done by comparing imaging biomarkers seen with amyloid PET and the tracer C-11 PIB at baseline to imaging biomarkers collected longitudinally, at years 1, 2, and/or 3.

  2. AD Biomarkers seen on Tau PET at Baseline and Years 1, 2, and/or 3 [ Time Frame: 5 years ]
    This Project aims to identify factors that signal the transition from asymptomatic (preclinical) to symptomatic Alzheimer disease (AD). This will be done by comparing imaging biomarkers seen with tau PET and the tracer Flortaucipir at baseline to imaging biomarkers collected longitudinally, at years 1, 2, and/or 3.

  3. AD Biomarkers seen on MRI at Baseline and Years 1, 2, and/or 3 [ Time Frame: 5 years ]
    This Project aims to identify factors that signal the transition from asymptomatic (preclinical) to symptomatic Alzheimer disease (AD). This will be done by comparing imaging biomarkers seen with MRI at baseline to imaging biomarkers collected longitudinally, at years 1, 2, and/or 3.

  4. Compare and Correlate Predictive Ability of Biomarkers Seen with Different Imaging Variables for Onset of Symptoms [ Time Frame: 5 years ]
    This project aims to compare and correlate the predictive ability of baseline values and rates of change of molecular biomarkers of AD for onset of AD symptoms with other variables. Variables obtained in this project include: 1) volumetric MRI, 2) MRI measures of vascular burden, 3) functional MRI, 4) amyloid PET, and 5) tau PET.


Secondary Outcome Measures :
  1. Compare and Correlate Predictive Ability of Biomarkers Seen with Other Types of Variables for Onset of Symptoms [ Time Frame: 5 years ]
    This project aims to compare and correlate the predictive ability of baseline values and rates of change of molecular biomarkers of AD for onset of AD symptoms with other variables obtained through Knight ADRC data sharing, which include, 1) clinical (demographic information, socioeconomic status, Clinical Dementia Rating, etiology of cognitive disorder (when present), and comorbid disorders, including cardiovascular disease); 2) cross-sectional and longitudinal cognitive performance, 3) indicators of sleep disruption 4) APOE genotype and genetic variants associated with resilience novel CSF analytes of neurofilament light chain, neurogranin, and SNAP-25 as markers of axonal and synaptic injury.

  2. Disparities for molecular biomarkers of AD in non-Hispanic white (NHW) and African American (AA) older adults [ Time Frame: 5 years ]
    The study will also focus on disparities for molecular biomarkers of AD in non-Hispanic white (NHW) and African American (AA) older adults. Aim 2 will compare the risk (or the hazard) of developing AD symptoms by race, and will treat death as a potential competing risk in the progression of dementia.



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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants are referred from the Washington University Knight Alzheimer's Disease Research Center (ADRC). The ADRC is responsible for the recruitment, enrollment, and maintenance of the Total Registry (TR). The Knight ADRC primarily recruits participants by means of word of mouth and public service announcements from the greater metropolitan St. Louis area. A small percentage (~17%) of participants are referred by a Washington University physician.
Criteria

Inclusion Criteria:

  • Male or female, any race
  • Age > 18 years
  • Participation in one of the ongoing projects affiliated with the Knight ADRC at Washington University and referred by the MAP staff and a Washington University physician.
  • Normal cognition or early-stage symptomatic AD
  • Willing and able to undergo study procedures.
  • Capacity to give informed consent and follow study procedures

Exclusion Criteria:

  • Has any condition that, in the Investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the research procedures, or interfere with the collection/analysis of the data (e.g., participants with severe chronic back pain might not be able to lie still during the scanning procedures);
  • Has hypersensitivity to either AV-1451 or PIB or any of its excipients;
  • Contraindications to PET, CT or MRI (e.g. electronic medical devices, inability to lie still for extended periods) that make it unsafe for the individual to participate;
  • Severe claustrophobia;
  • Currently pregnant or breast-feeding. Women must agree to avoid becoming pregnant and must agree to refrain from sexual activity or to use reliable contraceptive methods for 24 hours following administration of Flortaucipir injection;
  • Must not have participated in any clinical trial involving a study drug or device within the 30-days prior to study enrollment;
  • Must not participate in another drug or device study prior to the end of this study participation;
  • Current or recent (within 12 months prior to screening) participation in research studies involving radioactive agents such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the U.S. Code of Federal Regulations (CFR) Title 21 Section 361.1.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=361.1


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): NCT04579120


Contacts
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Contact: Kelley Jackson, BA 314-362-1558 jacksonk@wustl.edu

Sponsors and Collaborators
Tammie L. S. Benzinger, MD, PhD
Investigators
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Principal Investigator: Tammie Benzinger, MD, PhD Washington University School of Medicine
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Responsible Party: Tammie L. S. Benzinger, MD, PhD, Professor of Radiology & Neurological Surgery, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04579120    
Other Study ID Numbers: 201906009
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will share imaging data with other researchers. They may be doing research in areas similar to this research or in other unrelated areas. These researchers may be at Washington University, at other research centers and institutions, or industry sponsors of research. We may also share research data with large data repositories (a repository is a database of information) for broad sharing with the research community. If individual research data is placed in one of these repositories only qualified researchers, who have received prior approval from individuals that monitor the use of the data, will be able to look at your information. The shared information will not include names but may be linked by a global unique identifier (GUID) number.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tammie L. S. Benzinger, MD, PhD, Washington University School of Medicine:
Dementia
Neuro-Degenerative Disease
Amyloid Plaque
Mild Cognitive Impairment
Brain Disease
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Corticosterone
Anti-Inflammatory Agents