Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2026
Cognitive outcomes of low-dose whole-brain radiation therapy in mild Alzheimer's disease: A multicenter, randomized, sham-controlled phase II clinical trial.
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Hong Eun-Hee, Kim Aryun, Kim Keun You, Rhee Hak Young, Shin Dong-Ick, Kim Ji Young, Cho Seong-Jun, Kim Dong-Yun, Jahng Geon-Ho, Lee Hyo Been, Park Woo-Yoon, Kim Byoung Hyuck, Chung Weon Kuu
Аннотация
BACKGROUND AND PURPOSE: Low-dose radiotherapy (LDRT) has shown potential in preclinical Alzheimer's disease (AD) models, but controlled clinical evidence is limited. We evaluated two whole-brain LDRT regimens in mild AD.
MATERIALS AND METHODS: In this multicenter, participant-blinded, three-arm phase II trial, amyloid-positive participants were randomized 1:1:1 to sham irradiation, 0.04 Gy per fraction (0.24 Gy total), or 0.5 Gy per fraction (3 Gy total), delivered twice weekly for 3 weeks. The primary endpoint was change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) score from baseline to 6 months. Twelve-month analyses were exploratory. Longitudinal outcomes were estimated using mixed-effects models.
RESULTS: Forty-one participants were randomized; 36 were included in the modified intention-to-treat population and 30 completed 12-month follow-up. At 6 months, adjusted between-group differences in ADAS-cog change versus sham were -2.08 points (95% CI, -7.06 to 2.89; p = 0.401) for 0.24 Gy and -2.92 points (95% CI, -6.72 to 0.89; p = 0.129) for 3 Gy. At 12 months, the corresponding exploratory differences were -3.02 points (95% CI, -10.00 to 3.96; p = 0.386) and -5.36 points (95% CI, -10.58 to -0.14; nominal p = 0.044). No treatment-related adverse events or radiologic safety concerns were identified.
CONCLUSIONS: The prespecified 6-month primary endpoint was not met. Exploratory 12-month and secondary analyses showed differences in selected cognitive outcomes, although the findings varied across doses and outcomes. These findings did not establish efficacy or a dose-response relationship and warrant confirmation in a larger trial with longer follow-up.
MATERIALS AND METHODS: In this multicenter, participant-blinded, three-arm phase II trial, amyloid-positive participants were randomized 1:1:1 to sham irradiation, 0.04 Gy per fraction (0.24 Gy total), or 0.5 Gy per fraction (3 Gy total), delivered twice weekly for 3 weeks. The primary endpoint was change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) score from baseline to 6 months. Twelve-month analyses were exploratory. Longitudinal outcomes were estimated using mixed-effects models.
RESULTS: Forty-one participants were randomized; 36 were included in the modified intention-to-treat population and 30 completed 12-month follow-up. At 6 months, adjusted between-group differences in ADAS-cog change versus sham were -2.08 points (95% CI, -7.06 to 2.89; p = 0.401) for 0.24 Gy and -2.92 points (95% CI, -6.72 to 0.89; p = 0.129) for 3 Gy. At 12 months, the corresponding exploratory differences were -3.02 points (95% CI, -10.00 to 3.96; p = 0.386) and -5.36 points (95% CI, -10.58 to -0.14; nominal p = 0.044). No treatment-related adverse events or radiologic safety concerns were identified.
CONCLUSIONS: The prespecified 6-month primary endpoint was not met. Exploratory 12-month and secondary analyses showed differences in selected cognitive outcomes, although the findings varied across doses and outcomes. These findings did not establish efficacy or a dose-response relationship and warrant confirmation in a larger trial with longer follow-up.