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Study Design
This pilot study will be a randomized, placebo-controlled, single-blind, multiple procedure group, single site study of up to thirty (30) subjects. This study will include a screening visit, 12 weeks of study treatment, and three re-evaluation visits. Total study participation is estimated to be approximately 22 weeks.
Multiple procedure groups
There will be a total of three procedure groups: two active procedure groups and one placebo group in this study, labeled A, B, and C. Each of the two active procedures will involve application of the active Resonator, but with a different Resonator procedure protocol in terms of device output configuration. In all other study aspects, including study qualification; number and frequency of procedure administrations, duration of individual procedure administrations and the total procedure administration protocol; and all pre-, during- and post-procedure activities and assessments, the three procedure groups will be identical. The reason for the two different active procedure groups is to meet one of the goals of this pilot study which is to explore effective Resonator device outputs for maximal impact on improving cognition function in patients with Alzheimer’s.
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