18F-AV-1451 PET Imaging in Participants Enrolled in the LEARN Study
NCT ID: NCT02850146
Last Updated: 2023-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
55 participants
INTERVENTIONAL
2016-08-31
2023-09-29
Brief Summary
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The study will run in parallel to the LEARN study. In this study, participants will undergo up to four (4) 18F-AV-1451 PET scans over a 4.5 year period. Imaging visits will occur at the throughout the participant's participation in the LEARN study (corresponding to LEARN Visit 1, between Visit 4 and 6, Visit 8, and Visit 11).
The LEARN-Tau study will (1) look at change in the amount of tau protein in the brain over time, measured by the 18F-AV-1451 PET scan, (2) see if tau protein in the brain of older individuals is associated with memory problems and (3) evaluate the safety of 18F-AV-1451 and any side effects that might be associated with it.
Site investigators, participants, and study partners will not be informed of the results of the 18F-AV-1451 PET scan results as they relate to the study; however, any findings that may be of potential medical concern will be provided for appropriate follow-up.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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18F-AV-1451
50 individuals who are cognitively normal, older, Aβ not elevated and enrolled in the LEARN study will undergo 18F-AV-1451 imaging procedures at 4 time points over a 4.5 year period.
18F-AV-1451
Interventions
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18F-AV-1451
Eligibility Criteria
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Inclusion Criteria
* Participants who sign an IRB approved informed consent form prior to any study procedure; and
* Participants who in the opinion of the investigator can tolerate the PET scan procedures.
Exclusion Criteria
* Has abnormal findings on physical examination or laboratory screening tests that suggest the participant might have a condition that could, in the opinion of the investigator, affect his or her response to the radiopharmaceutical and related testing procedures;
* Is deemed likely to be unable to perform all of the imaging procedures for any reason;
* Has a history of risk factors for torsades de pointes, including clinically significant findings on ECG, or is taking medications known to prolong QT interval such as citalopram ≥ 40 mg/day, disopyramide, dofetilide, ibutilide, procainamide, quinidine, sotalol, or bepridil; A list of restricted medications will be provided.
* Are females of childbearing potential (extremely unlikely in the LEARN eligible population ages 65 to 85) who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception. Females of childbearing potential must not be pregnant (negative serum or urine β-hCG at the time of screening and negative serum or urine β-hCG on imaging day) or breastfeeding at screening. Females must agree to avoid becoming pregnant, and both females and males must agree to refrain from sexual activity or to use reliable contraceptive methods for 24 hours following administration of 18F-AV-1451 Injection; Males with female partners who are pregnant or of childbearing potential must agree to refrain from sexual activity for 24 hours following administration of 18F-AV-1451 Injection. Additionally, males must agree not to donate sperm for 24 hours following administration of 18F-AV-1451 Injection;
* Has hypersensitivity to 18F-AV-1451 or any of its excipients.
65 Years
85 Years
ALL
Yes
Sponsors
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Alzheimer's Therapeutic Research Institute
OTHER
Alzheimer's Association
OTHER
Avid Radiopharmaceuticals
INDUSTRY
University of Southern California
OTHER
Responsible Party
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Paul Aisen
Director, Alzheimer's Therapeutic Research Institute
Principal Investigators
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Reisa Sperling, MD
Role: STUDY_DIRECTOR
Center for Alzheimer Research and Treatment Brigham and Women's Hospital
Locations
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Banner Alzheimer's Institute
Phoenix, Arizona, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Bioclinica Research North
The Villages, Florida, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
University of Rochester Medical Center
Rochester, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Butler Hospital Memory and Aging Program
Providence, Rhode Island, United States
Countries
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References
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Chien DT, Bahri S, Szardenings AK, Walsh JC, Mu F, Su MY, Shankle WR, Elizarov A, Kolb HC. Early clinical PET imaging results with the novel PHF-tau radioligand [F-18]-T807. J Alzheimers Dis. 2013;34(2):457-68. doi: 10.3233/JAD-122059.
Duyckaerts C, Brion JP, Hauw JJ, Flament-Durand J. Quantitative assessment of the density of neurofibrillary tangles and senile plaques in senile dementia of the Alzheimer type. Comparison of immunocytochemistry with a specific antibody and Bodian's protargol method. Acta Neuropathol. 1987;73(2):167-70. doi: 10.1007/BF00693783.
Nelson PT, Alafuzoff I, Bigio EH, Bouras C, Braak H, Cairns NJ, Castellani RJ, Crain BJ, Davies P, Del Tredici K, Duyckaerts C, Frosch MP, Haroutunian V, Hof PR, Hulette CM, Hyman BT, Iwatsubo T, Jellinger KA, Jicha GA, Kovari E, Kukull WA, Leverenz JB, Love S, Mackenzie IR, Mann DM, Masliah E, McKee AC, Montine TJ, Morris JC, Schneider JA, Sonnen JA, Thal DR, Trojanowski JQ, Troncoso JC, Wisniewski T, Woltjer RL, Beach TG. Correlation of Alzheimer disease neuropathologic changes with cognitive status: a review of the literature. J Neuropathol Exp Neurol. 2012 May;71(5):362-81. doi: 10.1097/NEN.0b013e31825018f7.
Xia CF, Arteaga J, Chen G, Gangadharmath U, Gomez LF, Kasi D, Lam C, Liang Q, Liu C, Mocharla VP, Mu F, Sinha A, Su H, Szardenings AK, Walsh JC, Wang E, Yu C, Zhang W, Zhao T, Kolb HC. [(18)F]T807, a novel tau positron emission tomography imaging agent for Alzheimer's disease. Alzheimers Dement. 2013 Nov;9(6):666-76. doi: 10.1016/j.jalz.2012.11.008. Epub 2013 Feb 12.
Related Links
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Alzheimer's Therapeutic Research Institute
Alzheimer's Association
Other Identifiers
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15-338729
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
18F-AV-1451-A17
Identifier Type: -
Identifier Source: org_study_id
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