Tau Pet Imaging in the Aging Brain Cohort Dedicated to Diversity Study

Alzheimer Disease Clinical Trial

— ABCD2-TAU  

Official title:

Tau Pet Imaging in the Aging Brain Cohort Dedicated to Diversity Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05393388
• Other study ID #: 844403
• Status: Recruiting
• Start date: May 9, 2022
• Est. completion date: May 2027

Study information

• Verified date: January 2024
• Source: University of Pennsylvania
• Contact: David A Wolk, MD
• Phone: 215-573-7495
• Email: david.wolk[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

We will conduct a Tau PET scan in cognitively normal older adults, enrolled in the Aging Brain Cohort Dedicated to Diversity Study (ABCD2-Tau) study at the University of Pennsylvania's Penn Memory Center/Alzheimer's Disease Core Center (PMC/ADC).Study duration will generally be a one-day study visit for PET imaging, but all subjects will be followed annually as part of their participation in the ABCD2 study. Findings from this study will likely provide insight into the mechanisms and distinctions of age-related cognitive decline and that of preclinical Alzheimer's Disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: May 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. Males and females African Americans = 65 years of age.

2. Part of the ABCD2 longitudinal cohort, protocol 844047, of the PMC/ADCC with consensus conference designation of normal cognition.

3. ABCD2 longitudinal visit must be completed or scheduled to be completed within 1 year prior to the [18F]AV-1451 TAU PET scan.

4. A brain MRI must be performed within 1 year prior to their study [18F]AV-1451 TAU PET scan date and be deemed of adequate quality that the scan may be used for study analysis, including 3T high-resolution imaging of medial temporal lobe structures.

5. An amyloid PET scan completed or scheduled within 1year of their study [18F]AV-1451

6. Women must be post-menopausal or surgically sterile.

Exclusion Criteria:

1. Have any medical or psychiatric conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study, including major depression and prior head trauma.

2. Have evidence of structural abnormalities such as major stroke or mass on MRI that is likely to interfere with analysis of the PET scan.

3. Inability to tolerate or contraindication to imaging procedures in the opinion of an investigator or treating physician.

4. Have a history of significant ongoing alcohol or substance abuse or dependence based on self-report.

5. Women of child bearing potential

• The inclusion / exclusion criteria will be ascertained through self-report in conjunction with any medical history available through the participant's medical or research records (EPIC or the ADC database)*

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Decline
• Cognitive Dysfunction

Intervention

Drug:
• [18F]AV-1451
[18F]AV-1451 has been developed as a positron emitting radiopharmaceutical for in vivo imaging of tau protein aggregates.

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania - Penn Memory Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Pennsylvania Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uptake of [18F]AV-1451 in the medial temporal lobe	A quantitative measurement of [18F]AV-1451(standardized value uptake ratio - SUVR) within the medial temporal lobe (MTL).from PET/CT	4 years
Primary	Volume of medial temporal lobe subregion	A quantitative measurement of volume (milimeters - mm) of medial temporal lobe (MTL) subregion from a high resolution MRI.	4 years
Primary	Thickness of medial temporal lobe subregion	A quantitative measurement of thickness (milimeters - mm) of medial temporal lobe (MTL) subregion from a high resolution MRI.	4 years