Neuroimaging in Healthy Aging and Senile Dementia (HASD_IND)

NCT04579120 | Recruiting FDA Drug

• 1 other identifier: 201906009
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 1

Brief Summary

To identify factors that signal the transition from asymptomatic (preclinical) to symptomatic Alzheimer disease (AD).

Conditions

Alzheimer Disease

Keywords

Dementia; Neuro-Degenerative Disease; Amyloid Plaque; Mild Cognitive Impairment; Brain Disease

Outcome Measures

Primary Outcomes (4)

• AD Biomarkers seen on Amyloid PET at Baseline and Years 1, 2, and/or 3

  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.

  5 years

• AD Biomarkers seen on Tau PET at Baseline and Years 1, 2, and/or 3

  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.

  5 years

• AD Biomarkers seen on MRI at Baseline and Years 1, 2, and/or 3

  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.

  5 years

• Compare and Correlate Predictive Ability of Biomarkers Seen with Different Imaging Variables for Onset of Symptoms

  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.

  5 years

Secondary Outcomes (2)

• Compare and Correlate Predictive Ability of Biomarkers Seen with Other Types of Variables for Onset of Symptoms

  5 years

• Disparities for molecular biomarkers of AD in non-Hispanic white (NHW) and African American (AA) older adults

  5 years

Study Arms (2)

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); Drug: F 18 AV-1451 (Flortaucipir)

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); Drug: F 18 AV-1451 (Flortaucipir)

Interventions

[11C]-Pittsburgh Compound B ([11C]PiB) DRUG

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.

Also known as: PiB

African American; Non-Hispanic White

F 18 AV-1451 (Flortaucipir) DRUG

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).

Also known as: F 18 AV-1451

African American; Non-Hispanic White

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tammie L. S. Benzinger, MD, PhD: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Plaque, Amyloid; Cognitive Dysfunction; Brain Diseases

Interventions

2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole; 7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Cognition Disorders

Study Officials

• Tammie Benzinger, MD, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelley Jackson, BA

CONTACT

314-362-1558; kelleyj@wustl.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Radiology & Neurological Surgery

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: October 8, 2020
• Study Start: September 1, 2021
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)