drugset / Trial / NCT04080544
Cognitive Decline and Alzheimer's Disease in the Dallas Lifespan Brain Study
NaSingle-groupOpen-labelDiagnostic
Summary
The investigators will conduct tau positron emission tomography (PET) scans on 125 adults using the radiopharmaceutical Flortaucipir F18 (\[18F\]AV-1451). This will allow the investigators to determine tau deposition across adults of different ages and assess the relationship of current tau burden to cognitive function and amyloid deposition collected over the previous 10-year interval.
Timeline
- Start
- 2019-01-15
- Primary completion
- 2022-06-30
- Completion
- 2022-06-30
Publications
- Background Balota D.A., Faust M.E. (2001). Attention in dementia of the Alzheimer's type. In: Boller F, Cappa S, editors. Handbook of Neuropsychology. 2nd Ed. NY: Elsevier Science; pp. 51-80.
- Background Bennett DA, Schneider JA, Tang Y, Arnold SE, Wilson RS. The effect of social networks on the relation between Alzheimer's disease pathology and level of cognitive function in old people: a longitudinal cohort study. Lancet Neurol. 2006 May;5(5):406-12. doi: 10.1016/S1474-4422(06)70417-3.
- Background Braak H, Braak E. Neuropathological stageing of Alzheimer-related changes. Acta Neuropathol. 1991;82(4):239-59. doi: 10.1007/BF00308809.
- Background Convit A, de Leon MJ, Golomb J, George AE, Tarshish CY, Bobinski M, Tsui W, De Santi S, Wegiel J, Wisniewski H. Hippocampal atrophy in early Alzheimer's disease: anatomic specificity and validation. Psychiatr Q. 1993 Winter;64(4):371-87. doi: 10.1007/BF01064929.
- Background Holm S: A Simple Sequentially Rejective Bonferroni Test. Scandinavian Journal of Statistics. 1979, 65 -670.
- Background Kemper S, Anagnopoulos C, Lyons K, Heberlein W. Speech accommodations to dementia. J Gerontol. 1994 Sep;49(5):P223-9. doi: 10.1093/geronj/49.5.p223.
- Background Khachaturian ZS. Diagnosis of Alzheimer's disease. Arch Neurol. 1985 Nov;42(11):1097-105. doi: 10.1001/archneur.1985.04060100083029. No abstract available.
- Background Killiany RJ, Moss MB, Albert MS, Sandor T, Tieman J, Jolesz F. Temporal lobe regions on magnetic resonance imaging identify patients with early Alzheimer's disease. Arch Neurol. 1993 Sep;50(9):949-54. doi: 10.1001/archneur.1993.00540090052010.
- Background Jack, C., Knopman, D., Jagust, W., Petersen, R., Weiner, M., Aisen, P., … Trojanowski, J. (2013). Update on hypothetical model of Alzheimer's disease biomarkers. Alzheimer's & Dementia, 9(4), 521-522.
- Background Jack CR Jr, Petersen RC, Xu YC, Waring SC, O'Brien PC, Tangalos EG, Smith GE, Ivnik RJ, Kokmen E. Medial temporal atrophy on MRI in normal aging and very mild Alzheimer's disease. Neurology. 1997 Sep;49(3):786-94. doi: 10.1212/wnl.49.3.786.
- Background Mohs RC, Ashman TA, Jantzen K, Albert M, Brandt J, Gordon B, Rasmusson X, Grossman M, Jacobs D, Stern Y. A study of the efficacy of a comprehensive memory enhancement program in healthy elderly persons. Psychiatry Res. 1998 Feb 27;77(3):183-95. doi: 10.1016/s0165-1781(98)00003-1.
- Background Park DC, Reuter-Lorenz P. The adaptive brain: aging and neurocognitive scaffolding. Annu Rev Psychol. 2009;60:173-96. doi: 10.1146/annurev.psych.59.103006.093656.
- Background Price JL, Ko AI, Wade MJ, Tsou SK, McKeel DW, Morris JC. Neuron number in the entorhinal cortex and CA1 in preclinical Alzheimer disease. Arch Neurol. 2001 Sep;58(9):1395-402. doi: 10.1001/archneur.58.9.1395.
- Background Reuter-Lorenz PA, Park DC. How does it STAC up? Revisiting the scaffolding theory of aging and cognition. Neuropsychol Rev. 2014 Sep;24(3):355-70. doi: 10.1007/s11065-014-9270-9. Epub 2014 Aug 21.
- Background Sperling RA, Aisen PS, Beckett LA, Bennett DA, Craft S, Fagan AM, Iwatsubo T, Jack CR Jr, Kaye J, Montine TJ, Park DC, Reiman EM, Rowe CC, Siemers E, Stern Y, Yaffe K, Carrillo MC, Thies B, Morrison-Bogorad M, Wagster MV, Phelps CH. Toward defining the preclinical stages of Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):280-92. doi: 10.1016/j.jalz.2011.03.003. Epub 2011 Apr 21.
- Background Storandt M, Grant EA, Miller JP, Morris JC. Rates of progression in mild cognitive impairment and early Alzheimer's disease. Neurology. 2002 Oct 8;59(7):1034-41. doi: 10.1212/wnl.59.7.1034.
- Background Trojanowski JQ, Clark CM, Schmidt ML, Arnold SE, Lee VM. Strategies for improving the postmortem neuropathological diagnosis of Alzheimer's disease. Neurobiol Aging. 1997 Jul-Aug;18(4 Suppl):S75-9. doi: 10.1016/s0197-4580(97)00075-4.
- Background Whalley LJ. Brain ageing and dementia: what makes the difference? Br J Psychiatry. 2002 Nov;181:369-71. doi: 10.1192/bjp.181.5.369. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Flortaucipir F18 | Diagnostic / imaging agent | 370 mbq | Intravenous |