- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03816228
Imaging of Brain Structural/Functional Connectivity and Amyloid and Tau Lesions in APOE4 Carriers. (Protocol_Z)
March 11, 2024 updated by: Tammie L. S. Benzinger, MD, PhD
Imaging of Brain Structural/Functional Connectivity and Amyloid and Tau Lesions in APOE4 Carriers. (IND 123119, Protocol Z)
To advance current knowledge on the vascular contributions to dementia
Study Overview
Detailed Description
This is a multi-center study at Washington University (WASH U), University of Southern California (USC), and Huntington Medical Research Institute (HMRI).The overall goal of both the AA program and the PPG program is to advance current knowledge on the vascular contributions to dementia particularly in individuals with the major genetic risk factor for late-onset AD, i.e., apolipoprotein E-ε4 (APOE4) gene that develop early vascular dysfunction and significant cerebrovascular pathology compared to non-carriers, and establish whether the neurovasculature plays a key role in cognitive decline, and therefore is a key new therapeutic target to treat dementia in APOE4 carriers.
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kelley M Jackson, BA
- Phone Number: 314-362-1558
- Email: kelleyj@wustl.edu
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
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.
Description
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
- 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
Exclusion Criteria:
- Any illness preventing cooperation with testing or longitudinal participation
- Exclusion from the Knight ADRC or DIAN referring project
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Experimental Flortaucipir
Participants will receive a single intravenous bolus injection of flortaucipir along with PET imaging.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
F 18 T807 Standard Uptake Value Ratios
Time Frame: 5 years
|
F 18 T807 Standard Uptake Value Ratios (SUVR) will be correlated with other imaging modalities (MRI, PET amyloid imaging) and cognitive performance.
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tammie Benzinger, MD, PhD, Washington University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2022
Primary Completion (Actual)
October 11, 2022
Study Completion (Actual)
October 11, 2022
Study Registration Dates
First Submitted
January 22, 2019
First Submitted That Met QC Criteria
January 22, 2019
First Posted (Actual)
January 25, 2019
Study Record Updates
Last Update Posted (Actual)
March 13, 2024
Last Update Submitted That Met QC Criteria
March 11, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IND 123119 Protocol Z
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
We will share the 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 the research data with large data repositories (a repository is a database of information) for broad sharing with the research community.
The participant"s 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 this information.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alzheimer Disease
-
ProgenaBiomeRecruitingAlzheimer Disease | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3 | Alzheimer Disease 4 | Alzheimer Disease 7 | Alzheimer Disease 17 | Alzheimer Disease 5 | Alzheimer Disease 6 | Alzheimer Disease 8 | Alzheimer Disease 10 | Alzheimer... and other conditionsUnited States
-
Cognito Therapeutics, Inc.RecruitingCognitive Impairment | Dementia | Alzheimer Disease | Mild Cognitive Impairment | Cognitive Decline | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | MCI | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Cognitive Impairment, Mild | Alzheimer Disease 1 | Dementia, Mild | Alzheimer... and other conditionsUnited States
-
AphiosNot yet recruitingDementia | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3
-
Capital Medical UniversityPeking University First Hospital; The First Affiliated Hospital of Anhui Medical... and other collaboratorsRecruitingAlzheimer Disease | Familial Alzheimer Disease (FAD)China
-
University of PennsylvaniaNational Institute on Aging (NIA)CompletedDementia | Alzheimer Disease, At Risk | Alzheimer Disease, Protection AgainstUnited States
-
Kyoto UniversityOsaka University; Mie University; Tokushima University; Tokyo Metropolitan Geriatric... and other collaboratorsCompletedFamilial Alzheimer Disease (FAD) | PSEN1 MutationJapan
-
University of ArizonaNational Institute on Aging (NIA); University of Southern California; Syneos... and other collaboratorsRecruitingNeurodegenerative Diseases | Alzheimer Dementia | Late Onset Alzheimer DiseaseUnited States
-
National Taiwan Normal UniversityCompletedAlzheimer Disease 2 Due to Apoe4 IsoformTaiwan
-
Northwell HealthRecruitingAlzheimer Disease | Alzheimer Disease With Delusions | Alzheimer Disease With PsychosisUnited States
-
University of Kansas Medical CenterNational Institute on Aging (NIA)CompletedHealthy Aging | Alzheimer Disease 2 Due to Apoe4 IsoformUnited States
Clinical Trials on F 18 T807 Flortaucipir
-
Avid RadiopharmaceuticalsCompletedAlzheimer DiseaseUnited States
-
Avid RadiopharmaceuticalsCompleted
-
Avid RadiopharmaceuticalsCompleted
-
Avid RadiopharmaceuticalsCompleted
-
Avid RadiopharmaceuticalsCompleted
-
Avid RadiopharmaceuticalsCompletedAlzheimer DiseaseUnited States
-
Avid RadiopharmaceuticalsCompletedAlzheimer Disease | Mild Cognitive Impairment
-
Avid RadiopharmaceuticalsTerminated
-
Avid RadiopharmaceuticalsThe Cleveland ClinicCompleted
-
Avid RadiopharmaceuticalsCompleted