Imaging of Brain Structural/Functional Connectivity and Amyloid and Tau Lesions in APOE4 Carriers.

NCT03816228 | Withdrawn FDA Drug

• 1 other identifier: IND 123119 Protocol Z
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To advance current knowledge on the vascular contributions to dementia

Conditions

Alzheimer Disease

Keywords

Dementia; Taupathies; Brain Disease; Mild Cognitive Impairment; Neurodegenerative Disease

Outcome Measures

Primary Outcomes (1)

• F 18 T807 Standard Uptake Value Ratios

  F 18 T807 Standard Uptake Value Ratios (SUVR) will be correlated with other imaging modalities (MRI, PET amyloid imaging) and cognitive performance.

  5 years

Study Arms (1)

Experimental Flortaucipir

Participants will receive a single intravenous bolus injection of flortaucipir along with PET imaging.

Drug: F 18 T807 Flortaucipir

Interventions

F 18 T807 Flortaucipir DRUG

Participants will receive a single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807. For those who cannot tolerate the full exam, participants will receive single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807.

Also known as: 18F-AV-1451

Experimental Flortaucipir

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

A total of participants currently enrolled in ongoing projects affiliated with the Knight ADRC will be recruited. Without disclosing individual genetic risk status, 202 of these participants will include a mix of APOE4/4 (\~7%), APOE3/4 (\~30%), and APOE3/3 (\~63%) carriers. In addition, without disclosing individual mutation status, \~40 PSEN1 carriers and non-carrier family members currently enrolled in the Dominantly Inherited Alzheimer Network (DIAN) study at Washington University will be recruited.

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
• Females of childbearing potential without documented history of menopause or hysterectomy who do participate must not be pregnant or breastfeeding at screening
• (negative urine β-HCG within 24 hours prior to injection), and must agree to avoid becoming pregnant. Females of childbearing potential who do not agree to use reliable contraception or refrain from sexual activity for 24 hours following administration of flortaucipir injection.
• Enrollment in DCE-MRI study
• Capacity to give informed consent and follow study procedures

You may not qualify if:

• Any illness preventing cooperation with testing or longitudinal participation
• Has a high risk for Torsades de Pointes or is taking medications known to prolong or may prolong QT interval (refer to study attachment "Restricted Medication List").
• MRI contraindications (e.g. electronic medical devices, severe claustrophobia, inability to lie still for long periods) that make it unsafe to participate in an MRI scan, using standard screening processes implemented by Washington University and Barnes-Jewish Hospital
• Currently pregnant or breastfeeding

Sponsors & Collaborators

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

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (3)

• Akinyemi RO, Mukaetova-Ladinska EB, Attems J, Ihara M, Kalaria RN. Vascular risk factors and neurodegeneration in ageing related dementias: Alzheimer's disease and vascular dementia. Curr Alzheimer Res. 2013 Jul;10(6):642-53. doi: 10.2174/15672050113109990037.

  PMID: 23627757 BACKGROUND

• Fleisher A, Grundman M, Jack CR Jr, Petersen RC, Taylor C, Kim HT, Schiller DH, Bagwell V, Sencakova D, Weiner MF, DeCarli C, DeKosky ST, van Dyck CH, Thal LJ; Alzheimer's Disease Cooperative Study. Sex, apolipoprotein E epsilon 4 status, and hippocampal volume in mild cognitive impairment. Arch Neurol. 2005 Jun;62(6):953-7. doi: 10.1001/archneur.62.6.953.

  PMID: 15956166 BACKGROUND

• Petersen RC, Doody R, Kurz A, Mohs RC, Morris JC, Rabins PV, Ritchie K, Rossor M, Thal L, Winblad B. Current concepts in mild cognitive impairment. Arch Neurol. 2001 Dec;58(12):1985-92. doi: 10.1001/archneur.58.12.1985.

  PMID: 11735772 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Brain Diseases; Cognitive Dysfunction; Neurodegenerative Diseases

Interventions

7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Tammie Benzinger, MD, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

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: January 22, 2019
• First Posted: January 25, 2019
• Study Start: January 1, 2022
• Primary Completion: October 11, 2022
• Study Completion: October 11, 2022
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)