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• W3093805223 abstract "Report neurocognitive, imaging, and safety outcomes from a phase IIa trial of low-dose whole brain RT (LD-WBRT) for early Alzheimer’s dementia (eAD) in 5 patients who completed all study assessments. Based on improvements in amyloid burden and cognition in murine models and favorable outcomes with low-dose RT for systemic amyloidosis, we launched a human trial for eAD, defined by NINCDS-ADRDA criteria with confirmatory Florbetapir and FDG PET findings. The capacity to complete neurocognitive function (NCF), psychological function (PF), and quality of life (QOL) assessments was requisite. NCF was measured via a battery of validated assessments (WTAR, MMSE-2, HVLT-R, BVMT-R, WAIS-IV Digit Span and Coding, Trailmaking Parts A+B, COWAT, Semantic Fluency, Grooved Pegboard, BNT and JLO), PF via PHQ-9 and GAD-7, and QOL per QOL-AD and QUALID. Participant and informant ratings of cognition consisted of ECOG questionnaires. Participants underwent screening physical examination, screening as well as pre-treatment NCF, PF and QOL assessments, and screening Florbetapir and FDG PET imaging. Each received LD-WBRT (2Gyx5). Post-treatment evaluations included 6wk, 3mo, 9mo, and 12mo physical exams, NCF, PF, and QOL assessments (with BNT and JLO only at baseline and 12mo), 6mo FDG and Florbetapir PET, and Data Safety and Monitoring Committee (DSMC) toxicity evaluation. 5 patients were treated with LD-WBRT and completed all study assessments. Mean age was 73.2 (range 69-77) yrs, 3 female and 2 male. Comparing pre-treatment and 12mo MMSE-2 T-scores, 3 improved, 1 remained stable, and 1 declined. Skills expected to wane in early AD (naming, learning and memory) remained broadly stable at 1 year in 4 of 5, with trends for improved verbal learning in 3. The participant who declined in these measures and on Grooved Pegboard and Semantic Fluency, met the lowest-end inclusion criteria and was the eldest. Processing speed (Grooved Pegboard, WAIS-IV Coding, Trailmaking A), attention (WAIS-IV Digit Span), visuospatial skills (JLO, BVMT-R Copy), executive functions (Trailmaking A+B, lexical fluency), mood (PHQ-9, GAD-7) and QOL (QOL-AD, QUALID, ECOG) assessments remained stable, with exception of some declines in semantic fluency suggestive of temporal lobe dysfunction. However, there were improvements in several domains at 9 to 12mo. PET imaging remained stable with possible modest improvements in hippocampal amyloid and parietotemporal FDG. Results were independently reviewed by the Data Safety monitoring committee, and no safety issues encountered except transient epilation. 4 of the initial 5 patients with eAD treated with LD-WBRT experienced overall stability in NCF, PF, and QOL, with trends for improved verbal learning, and stability to possible improvement in PET imaging. The trial will continue to 15 patients at 2Gy x 5, then 15 at 2Gy x 10. Longer follow up is now planned to evaluate whether improvements in several domains at 9 to 12 months are confirmed." @default.
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• W3093805223 date "2020-11-01" @default.
• W3093805223 modified "2023-10-14" @default.
• W3093805223 title "Low-Dose Whole Brain Radiation Therapy For Early Alzheimer’s Dementia: Early Results From A Phase IIa Trial" @default.
• W3093805223 doi "https://doi.org/10.1016/j.ijrobp.2020.07.162" @default.
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