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Linking Tau PET to Medial Temporal Lobe Subregions With High Resolution MRI

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ClinicalTrials.gov Identifier: NCT04251130
Recruitment Status : Active, not recruiting
First Posted : January 31, 2020
Last Update Posted : March 25, 2020
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
The investigators will conduct a tau PET scan in cognitively normal older adults and patients with Mild Cognitive Impairment (MCI), 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).

Condition or disease Intervention/treatment
Mild Cognitive Impairment Drug: 2-(2-([18F]fluoro)pyridin-4-yl)-9H-pyrrolo[2,3-b:4,5-c']dipyridine

Detailed Description:
This is a cross-sectional and longitudinal study using the radiotracer [18F]-PI-2620 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 or MCI. All subjects will already be part of the longitudinal cohort study, known as the "NACC" cohort, of the PMC/ADC (protocol 068200). Participants will provide informed consent for this protocol before beginning any study procedures. After screening assessments, participants will undergo PET scan imaging with [18F]PI-2620. There will be one follow-up [18F]PI-2620 PET scan approximately 18 +/- 6 months after bas eline scan.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Linking Tau PET to Medial Temporal Lobe Subregions With High Resolution MRI
Actual Study Start Date : March 11, 2020
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2026

Group/Cohort Intervention/treatment
Cognitively Normal Older Adults
Subjects will receive an IV bolus injection of approximately 5 mCi ± 20% of [18F]PI-2620. All subjects will undergo a 30-minute brain PET/CT scan performed starting at approximately 45 minutes' post injection of [18F]PI-2620. A low-dose CT scan will be acquired according to standard PET/CT imaging procedures to be used for attenuation correction. All images will be reconstructed using standard reconstruction techniques
Drug: 2-(2-([18F]fluoro)pyridin-4-yl)-9H-pyrrolo[2,3-b:4,5-c']dipyridine
A small molecule aimed for binding and PET-imaging of aggregated tau protein in the human brain.
Other Name: [18F]PI-2620

Mild Cognitively Impaired Older Adults
Subjects will receive an IV bolus injection of approximately 5 mCi ± 20% of [18F]PI-2620. All subjects will undergo a 30-minute brain PET/CT scan performed starting at approximately 45 minutes' post injection of [18F]PI-2620. A low-dose CT scan will be acquired according to standard PET/CT imaging procedures to be used for attenuation correction. All images will be reconstructed using standard reconstruction techniques
Drug: 2-(2-([18F]fluoro)pyridin-4-yl)-9H-pyrrolo[2,3-b:4,5-c']dipyridine
A small molecule aimed for binding and PET-imaging of aggregated tau protein in the human brain.
Other Name: [18F]PI-2620




Primary Outcome Measures :
  1. Correlation between PI-2620 SUVR and MTL subregion thickness [ Time Frame: Baseline ]
    Correlation between cross-sectional PI-2620 standard uptake value ratio (SUVR) and MTL subregion thickness (mm) in both controls and MCI.

  2. Interaction between PI-2620 SUVR and amyloid status prediction of MTL subregion thickness [ Time Frame: Baseline ]
    Interaction between cross-sectional PI-2620 standard uptake value ratio (SUVR) and amyloid status for prediction of MTL subregion thickness (mm) in both controls and MCI.

  3. Correlation between longitudinal PI-2620 SUVR and MTL subregion thickness [ Time Frame: 18-24 months ]
    Correlation between longitudinal PI-2620 standard uptake value ratio (SUVR) and MTL subregion thickness (mm) in both controls and MCI.

  4. Interaction between longitudinal PI-2620 SUVR and amyloid status for prediction of MTL subregion thickness [ Time Frame: 18-24 months ]
    Interaction between longitudinal PI-2620 standard uptake value ratio (SUVR) and amyloid status for prediction of MTL subregion thickness (% annual change) in both controls and MCI.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults cognitively normal or Mild Cognitive Impairment (MCI).
Criteria

Inclusion Criteria:

  • Males and females ≥ 60 years of age.
  • Part of the NACC longitudinal cohort (IRB# 068200) of the PMC/ADCC with consensus conference designation of cognitively normal or Mild Cognitive Impairment (MCI).
  • NACC longitudinal visit completed or scheduled within 6 months before or after enrollment in this study.
  • Women must be post-menopausal or surgically sterile.
  • An amyloid PET scan, completed as a part of the NACC protocol (IRB# 825943), must be performed or scheduled within 12 months before or after the [18F]PI-2620 PET scan.
  • A brain MRI, completed as a part of NACC protocol (IRB# 068200), must be performed or scheduled within 6 months before or after the [18F]PI-2620 PET scan. Scan should be of adequate research quality, including 3 Tesla and/or 7 Tesla high-resolution imaging of MTL structure.

Exclusion Criteria:

  • 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.
  • 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 a history of significant or ongoing alcohol abuse or substance abuse or dependence based on medical record review or self-reported.

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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251130


Locations
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United States, Pennsylvania
UPenn
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institutes of Health (NIH)
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04251130    
Other Study ID Numbers: 833864
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders