Over 200 publications, including the composite endpoints regulators now recognize. We publish our methodology in the open so reviewers meet it before your submission does.
Alzheimer's Association International Conference (AAIC) · 2024:Poster Tue-17 · Hendrix, Dickson et al.
Companies recently identified clinical study sites engaging in fraudulent practices, reducing success in Alzheimer's disease (AD) clinical trials. Successful trials are reliable…
When the sample size a conventional design demands is larger than the trial you can run, a Global Statistical Test lets the clinical-endpoint hypotheses be tested anyway. The paper sets out when GST applies, how it is pre-specified, and how it has been received in review.
13 publications
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2021 · Alzheimer's & Dementia: Translational Research & Clinical Interventions
Dickson, Samuel · Hendrix, Suzanne · Brown, Bruce · Nicodemus-Johnson, Jessie
2021 · Alzheimer's & Dementia
Dickson, Samuel · Nicodemus-Johnson, Jessie · Knowlton, Newman · Syndergaard, Tess · Neff, Jacob · Hennessey, Sean · Hendrix, Suzanne
2021 · Movement Disorders
Hendrix, Suzanne · Hennessey, Sean · Dickson, Samuel
Objective: An exploratory analysis to examine the MDS-UPDRS 1-3 subitems of PD patients who underwent specialized light therapy (SLT) to assess the breadth of impact of SLT on motor and non-motor symptoms. Background: Several trials of light therapy have been conducted in PD patients using a variety of endpoints. These studies indicate benefit of PD on a variety of motor and non-motor symptoms; however, each study reports only one to a few endpoints. We previously reported the MDS-UPDRS 1-3 combined scores for a SLT PD study [1] and expand by reporting each of the subitems to better evaluate the impact of SLT. Method: A prospective, randomized, double-blind, multi-center, controlled study was conducted on PD subjects on dopaminergic therapy without significant motor complications. Participants were randomized 1:1 to narrow band blue/green light (active) or low intensity white light (control), thought to not provide clinical benefit for one hour in the evening for 6 months. The previously reported primary endpoint was change from baseline (BL) to 6 months (6M) in the MDS-UPDRS 1-3. Significance of the subitem analysis was considered at p<0.05, trending significance was p<0.10 and no corrections for multiple comparisons were done. Results: 92 subjects (45 active, 47 control) were enrolled at 3 centers. The primary endpoint MDS-UPDRS 1-3 improved by 17.7(2.8) for the active vs 9.7(3.4) for control. The difference of 8.0(4.4) trended towards significance P=0.074. The subitems for each of the part of the MDS-UPDRS are shown in [figure 1]. MDS-UPDRS 1 has 13 subparts, 3 subitems favored and another 3 trended for SLT. MDS-UPDRS 2 has 13 subparts, 2 favored and another 1 trended for SLT. MDS-UPDRS 3 has 33 subparts, 2 favored and another 2 trended for SLT. In total the MDS-UPDRS 1-3 has 59 subitems, 7 favored and 6 trended in favor of SLT. None of the 59 subitems favored or trended in favor for control. Conclusion: SLT had a broad impact across a broad range of subitems measured by MDS-UPDRS. Those that significantly favored SLT treatment include depressed mood, anxious mood, urinary problems, chewing and swallowing, eating tasks, rest tremor amplitude RUE, rest tremor amplitude RLE. Daytime sleepiness and fatigue which are typically worsened by dopaminergic treatments, trended in favor of SLT. If confirmed in larger SLT studies this would represent a broad ranging impact to the treatment of motor and non-motor symptoms in PD.
2021 · Journal of Alzheimer's Disease Reports
2021 · Alzheimer's & Dementia
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