P4-229: Effects of extended-release memantine (28 mg/day) on cognitive domains in patients with moderate to severe Alzheimer's disease: Post hoc analysis of a randomized trial

2011 ◽  
Vol 7 ◽  
pp. S784-S785
Author(s):  
Michael Tocco ◽  
Suzanne Hendrix ◽  
Michael Miller ◽  
Vojislav Pejovic ◽  
Stephen Graham
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Randomized Trial ◽  
Extended Release ◽  
Cognitive Domains ◽  
Post Hoc Analysis ◽  
Post Hoc

scholarly journals ALZHEIMER’S DISEASE COMPOSITE SCORE: A POST-HOC ANALYSIS USING DATA FROM THE LIPIDIDIET TRIAL IN PRODROMAL ALZHEIMER’S DISEASE

2019 ◽  
pp. 1-5
Author(s):  
S.B. Hendrix ◽  
H. Soininen ◽  
A.M.J. van Hees ◽  
N. Ellison ◽  
P.J. Visser ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Composite Endpoint ◽  
Composite Score ◽  
Control Group ◽  
Post Hoc Analysis ◽  
Intention To Treat ◽  
Prodromal Ad ◽  
Using Data ◽  
Post Hoc

As research evolves in prodromal AD, the need to validate sufficiently sensitive outcome measures, e.g. the Alzheimer’s Disease Composite Score (ADCOMS) is clear. In the LipiDiDiet randomized trial in prodromal AD, cognitive decline in the study population was much less than expected in the timeframe studied. While the primary composite endpoint was insufficiently sensitive to detect a difference in the modified intention to treat population, the per-protocol population showed less decline in the active than the control group, indicating better treatment effects with regular product intake. These results were further strengthened by significant benefits on secondary endpoints of cognition and function, and brain atrophy. The present post-hoc analysis investigated whether ADCOMS could detect a difference between groups in the LipiDiDiet population (138 active, 140 control). The estimated mean change in ADCOMS from baseline (standard error) was 0.085 (0.018) in the active and 0.133 (0.018) in the control group; estimated mean treatment difference -0.048 (95% confidence intervals -0.090, -0.007; p=0.023), or 36% less decline in the active group. This suggests ADCOMS identified the cognitive and functional benefits observed previously, confirming the sensitivity of this composite measure.

scholarly journals Effects of Body Weight on the Safety of High-dose Donepezil in Alzheimer’s Disease: Post-hoc Analysis of a Multicenter, Randomized, Open-label, Parallel Design, Three-arm Clinical Trial

2020 ◽  
Author(s):  
Yun Jeong Hong ◽  
Hyun Jeong Han ◽  
YoungChul Youn ◽  
Kyung Won Park ◽  
Dong Won Yang ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Body Weight ◽  
Dose Titration ◽  
High Dose ◽  
Open Label ◽  
Post Hoc Analysis ◽  
Cognitive Benefits ◽  
N 93 ◽  
Post Hoc

Abstract Background: Donepezil 23mg is considered for Alzheimer’s disease (AD) to optimize cognitive benefits; however, this increases adverse events (AEs), which can negatively influence drug adherence. We investigated whether baseline body weight (BW) differs based on the presence of AEs, and which factors were relevant to the safety of high-dose donepezil. Methods: This study was a post-hoc analysis of a multicenter randomized trial between 2014 and 2016. We included patients with moderate to severe AD treated with donepezil 10mg/day and the daily dose was escalated to 23mg with/without dose titration. Dose titration indicates 15mg/day of donepezil before the escalation or 10mg and 23mg/day on alternate days before the escalation during the first 4 weeks. The patients were divided into two groups according to the occurrence of AEs of special interest (AESIs) to compare baseline characteristics. We also assessed relationships between BW and AESIs.Results: Among 160 safety set population, baseline BWs were different between the AESI (+) (n=67) and AESI (-) (n=93) groups. Baseline BW was inversely correlated with the occurrence of AESIs (p=0.020), and this relationship was more prominent in the no-dose titration group (p=0.009) and disappeared in the dose titration groups (p>0.05).Conclusions: BW was the most important factor which correlated with cholinergic AEs. Hence, stepwise dose-titration should be considered, particularly in patients with low BW, to minimize the inverse relationship between BW and AEs occurrence. (‘Clinicaltrials.gov’ number NCT02550665 registered on Sep. 15, 2015)

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