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The clinical endpoints of Alzheimer's Disease Composite Score (ADCOMS), Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) and Clinical Dementia Rating Sum of Boxes (CDR-SB) were also assessed from baseline to 18 months of treatment.
The mean decline in the ADAS-Cog was 6.1 points in the mild AD group vs.
When the trials were combined, the difference between active drug and placebo was significant on two of the instruments (the ADAS-cog and the CIBIC-plus), albeit with very small effect sizes.
Results After 6 weeks of the study, ADAS-cog scores improved from baseline in all groups, including in those patients receiving placebo.
Age, CMMSE score, ADAS-Cog total score, 10-minute delayed recall and CVFT scores yielded significant correlations with all MacCAT-T summary scores.
However, the most recent trial failed to show any statistically significant or clinically meaningful changes in any of the three outcomes it assessed: ADAS-cog, ADAS-activities of daily living (ADAS-ADL), or the Clinical Dementia Rating-sum of boxes (CDR-sb).
Patients taking azeliragon compared with placebo did not improve in cognitive or functional outcomes as measured by the Alzheimer's Disease Assessment Scale-cognitive subscale, or ADAS-cog, and the Clinical Dementia Rating Scale Sum of Boxes, or CDR-sb.
According to the study, treatment with DBSf suggested clinical benefit at 12 months in patients aged 65 and older based on Clinical Dementia Rating sum of boxes (CDR-SB) and the Alzheimer's Disease Assessment Scale cognitive subscale - 13 item, (ADAS-Cog 13).
The primary efficacy analysis will be based on the changes in ADAS-cog (Alzheimer s Disease Assessment Scale cognitive subscale) and CDR-sb (Clinical Dementia Rating sum of boxes).
The primary endpoint was the total change from baseline on an 11-item version of the Alzheimer's Disease Assessment Scale-Cognition domain (ADAS-Cog 11).
Measures used for participants included the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) to measure cognitive function, the Quality of Life in Alzheimer's Disease (QoL-AD) tool to measure quality of life, and the Short Physical Performance Battery (SPPB) to measure physical function.
The companies said that Dimebon did not achieve statistically significant results for either of the two co-primary endpoints, the Alzheimer's Disease Assessment Scale, which is the cognitive subscale (ADAS-cog) which measures cognitive ability, or the Alzheimer's Disease Cooperative Study, the Activities of Daily Living (ADCS-ADL), which measures self care and daily function.
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- Adar II
- Adar II
- Adar Parab
- Adar Rishon
- Adar Sheni
- Adar Sheni
- Adare, Lord
- Adarsh Gaon Yojana
- Adas Kodesch Shel Emeth
- Adashev, Aleksei
- Adashev, Aleksei Fedorovich
- Adashev, Daniil
- Adashev, Daniil Fedorovich