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| ID | Type | Description | Link |
|---|---|---|---|
| 15-338729 | Other Grant/Funding Number | Alzheimer's Association |
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| Name | Class |
|---|---|
| Alzheimer's Therapeutic Research Institute | OTHER |
| Alzheimer's Association | OTHER |
| Avid Radiopharmaceuticals | INDUSTRY |
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Approximately 50 participants enrolled in the LEARN study (NCT02488720) will be enrolled in the LEARN-Tau study. The study designed to evaluate the imaging characteristics of 18F-AV-1451 in participants enrolled in the LEARN study and to expand the safety database of 18F-AV-1451.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-AV-1451 | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-AV-1451 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of change of tau deposition as measured by 18F-AV-1451 | 3 years | |
| Change in tau deposition as measured by 18F-AV-1451 standardized uptake value ratio (SUVR) from the baseline scan | Baseline, 84 weeks, 168 weeks |
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Participants should meet inclusion and exclusion criteria for the LEARN study, and in addition:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Reisa Sperling, MD | Center for Alzheimer Research and Treatment Brigham and Women's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Alzheimer's Institute | Phoenix | Arizona | 85006 | United States | ||
| Yale University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23234879 | Background | 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. | |
| 2440224 | Background | 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. |
| Label | URL |
|---|---|
| Alzheimer's Therapeutic Research Institute | View source |
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| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D020774 | Pick Disease of the Brain |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D057180 | Frontotemporal Dementia |
| D057174 | Frontotemporal Lobar Degeneration |
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| ID | Term |
|---|---|
| C000591008 | 7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole |
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| New Haven |
| Connecticut |
| 06510 |
| United States |
| Bioclinica Research North | The Villages | Florida | 32162 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Rochester Medical Center | Rochester | New York | 14620 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Butler Hospital Memory and Aging Program | Providence | Rhode Island | 02906 | United States |
| 22487856 | Background | 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. |
| 23411393 | Background | 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. |
| Alzheimer's Association | View source |
| Avid Radiopharmaceuticals | View source |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |