- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03189485
Tau PET Imaging in the NACC Study Cohort (TPI)
Tau PET Imaging in the NACC Study Cohort: Modulators of MTL Subregion Structure and Function in Normal and Pathological Aging
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigator will conduct a tau PET scan in cognitively normal older adults enrolled in the National Alzheimer's Coordinating Center (NACC) study at the University of Pennsylvania's Penn Memory Center/Alzheimer's Disease Core Center (PMC/ADC).
Study Duration: Study duration will generally be a one-day study visit, but all subjects will be followed annually as part of their participation in the NACC study.
Participants may be asked to obtain a longitudinal follow-up scan approximately 2-3 years after the baseline scan.
Study Center(s): Penn Memory Center/Alzheimer's Disease Core Center at Perelman Center for Advanced Medicine, UPHS.
Objectives: To collect Tau PET imaging in cognitively normal older adults adults and patients with Mild Cognitive Impairment (MCI), in the NACC study to determine relationship to clinical, cognitive, and other biomarker data. In particular, the investigator will examine relationship of tau PET to structural and functional measures of medial temporal lobe (MTL) subregions. 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.
Number of Subject: 200, approximately 150 cognitively normal older adults and 50 with mild cognitive impairment.
Diagnosis and Main Inclusion Criteria Eligible subjects will be NACC cohort participants who have received a consensus conference designation of "Cognitively Normal and patients with Mild Cognitive Impairment (MCI)". All participants must have had their annual NACC clinical and cognitive examination within 6 months of the tau PET imaging and an MRI scan (including high resolution imaging of medial temporal lobe regions) and amyloid PET within 12 months.
Study Design: This is a cross-sectional study using the radiotracer 18F-AV-1451 to determine the relationship of tau pathology to both cross-sectional and longitudinal clinical and biomarker data of NACC cohort participants who are Cognitively Normal and patient with mild cognitive impairment . All subjects will already be part of the longitudinal cohort study, known as the "NACC" cohort, of the PMC/ADC. For the current protocol, participants will provide informed consent before beginning any study procedures. After screening assessments, participants will undergo PET scan imaging with 18F-AV-1451 and again 2 to 3 years after the baseline scan.
Study Drug Administration: Subjects will receive a single IV bolus injection target dose of approximately 370 MBq (10 mCi ± 20%) of 18F-AV-1451 At approximately 75 minutes post dose, scanning will begin. An approximately 30-minute acquisition (six 5 minute intervals) will be performed.
Adverse events will be monitored continuously during the imaging session. Subjects who experience any adverse event during an imaging session will not be discharged until the event has resolved or stabilized.
Statistical Methodology This is a data gathering protocol to obtain molecular imaging data in a cohort of older adults without cognitive symptoms. However, specific analyses will include quantitative measures of 18F-AV-1451 within the medial temporal lobe (MTL) and its relationship to volume and thickness of MTL subregions measured with high-resolution MRI. Additional correlation and regression analyses will be performed to determine relationships between 18F-AV-1451 and cross-sectional and longitudinal measures acquired as part of each individuals participation in the NACC longitudinal cohort study, including, but not limited to, MRI imaging, neurocognitive testing, demographic information, genetic data, and clinical outcomes.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Martha Combs, MS
- Phone Number: 215-615-3084
- Email: martha.combs@pennmedicine.upenn.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- UPenn
-
Contact:
- Martha Combs, MS
- Phone Number: 215-662-3084
- Email: martha.combs@pennmedicine.upenn.edu
-
Contact:
- Jackie Lane, BS
- Phone Number: 215-662-7057
- Email: jacquline.lane@pennmedicine.upenn.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Males and females ≥ 60 years of age.
- Part of the NACC longitudinal cohort (Protocol #: 068200) of the PMC/ADCC with consensus conference designation of cognitively normal or MCI.
- NACC longitudinal visit must be completed or scheduled to be completed within 6 months of the 18F-AV-1451 TAU PET scan.
- A brain MRI must be performed within 12 months prior to their study scan date and be deemed of adequate quality that the scan may be used for study analysis, including 3T and/or 7 Tesla high-resolution imaging of medial temporal lobe structures.
- An amyloid PET scan completed or scheduled within 12 months of their study scan date
- Women must be post-menopausal or surgically sterile
Exclusion Criteria:
- Any medical or psychiatric conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
- Have evidence of structural abnormalities such as major stroke or mass on MRI that is likely to interfere with analysis of the PET scan
- Inability to tolerate or contraindication to imaging procedures in the opinion of an investigator or treating physician
- Have current clinically significant cardiovascular disease .Have a history of significant or ongoing alcohol abuse or substance abuse or dependence based on medical record review or self-reported
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Normal Controls and MCI
All subjects will receive 18F-AV-1451 PET scan.
|
Subjects will receive a single IV bolus injection target dose of approximately 370 MBq (10 mCi ± 20%) of 18F-AV-1451 At approximately 75 minutes post dose, scanning will begin.
An approximately 30-minute acquisition (six 5 minute intervals) will be performed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Examine uptake of 18F-AV-1451 in the medial temporal lobe (MTL) and its relationship with high-resolution structural and functional MRI measures of MTL subregions.
Time Frame: 2 years.
|
Specific analyses will include quantitative measures of 18F-AV-1451 within the medial temporal lobe (MTL) and its relationship to volume and thickness of MTL subregions measured with high-resolution MRI.
|
2 years.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine relationship to clinical, cognitive, and other biomarker data
Time Frame: 2 years.
|
Correlation and regression analyses will be performed to determine relationships between 18F-AV-1451 and cross-sectional and longitudinal measures acquired as part of each individuals participation in the NACC longitudinal cohort study, including, but not limited to, MRI imaging, neurocognitive testing, demographic information, genetic data, and clinical outcomes.
|
2 years.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Wolk, MD, University of Pennsylvania
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 825944
- R01AG055005 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 MCI
-
Philips Electronics Nederland B.V. acting through...Qserve; Dent Neurologic InstituteCompleted
-
Chang Gung Memorial HospitalNot yet recruiting
-
Chang Gung Memorial HospitalRecruitingMCI | SCD | Virtual RealityTaiwan
-
Università degli Studi di FerraraCompletedTest the Differences Between Schinder's TCI Model and MCIItaly
-
Université de SherbrookeAlzheimer's Association; Nestle Health ScienceRecruiting
-
RowanRecruitingMild Cognitive Impairment | MCIKorea, Republic of
-
Charite University, Berlin, GermanyCompletedMild Cognitive Impairment (MCI)Germany
-
Johns Hopkins UniversityNational Institute on Aging (NIA)CompletedMild Cognitive Impairment (MCI)United States
-
Immunotec Inc.RecruitingMild Cognitive Impairment (MCI)Canada
Clinical Trials on the radiotracer 18F-AV-1451
-
Columbia UniversityNational Institute of Neurological Disorders and Stroke (NINDS)CompletedTauopathies | Frontotemporal Dementia (FTD) | Frontotemporal Lobar Degeneration (FTLD)United States
-
Northwestern UniversityNational Institute on Aging (NIA)RecruitingPrimary Progressive Aphasia With Suspected Alzheimer's DiseaseUnited States
-
University of Southern CaliforniaAvid Radiopharmaceuticals; Alzheimer's Therapeutic Research Institute; Alzheimer...CompletedCognition DisordersUnited States
-
Tammie L. S. Benzinger, MD, PhDCompletedAlzheimer DiseaseUnited States
-
Tammie L. S. Benzinger, MD, PhDRecruiting
-
Washington University School of MedicineEnrolling by invitationAlzheimer DiseaseUnited States
-
Tammie L. S. Benzinger, MD, PhDCompletedAlzheimer Disease | Progressive Posterior Cortical Dysfunction (PPCD)United States
-
Avid RadiopharmaceuticalsWithdrawn
-
University of ZurichAvid Radiopharmaceuticals; Swiss Federal Institute of TechnologyActive, not recruitingHealthy | Neurocognitive Disorders | Alzheimer Disease | Mild Cognitive ImpairmentSwitzerland
-
Tammie L. S. Benzinger, MD, PhDCompletedAlzheimer Disease | HIVUnited States