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Fig. 1 | Alzheimer's Research & Therapy

Fig. 1

From: Adaptive crossover designs for assessment of symptomatic treatments targeting behaviour in neurodegenerative disease: a phase 2 clinical trial of intranasal oxytocin for frontotemporal dementia (FOXY)

Fig. 1

Two-stage phase II adaptive crossover trial design for intranasal oxytocin for frontotemporal dementia (FOXY). In stage 1, a total of 60 patients with frontotemporal dementia (FTD) are randomized to one of three dose schedules. In the crossover design, baseline assessments are completed at the beginning of each treatment period. After baseline, participants receive twice-daily intranasal sprays of placebo or oxytocin for 6 weeks and then undergo complete outcome assessments and optional lumbar puncture. The first treatment period is followed by a washout period with no sprays given for 6 weeks. At the end of the washout period, participants are re-baselined prior to 6 weeks of twice-daily intranasal spays of the alternate drug (placebo or oxytocin). In stage 2, 20 additional patients with FTD are randomized to the most promising dose identified at the planned interim analyses at the end of stage 1, and complete procedures identical to those in stage 1 are performed

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Alzheimer's Research & Therapy

ISSN: 1758-9193