Table 3.
11. Light chain (AL) amyloidosis, cardiac involvement: clinicaltrials.gov NCT02015312Estimated enrollment: 38Estimated completion: September 2017 (final data collection date for primary outcome measure) | Green tea compound EGCG Safety/efficacy Phase 2: randomized, double-blind study of safety/efficacy |
Recruiting Primary outcome measures:12 months change in LV mass Secondary outcome measures:change in QoL, number of adverse events according to CTC criteria, change in cardiac biomarkers, hematological improvement, organ response (non-heart), overall survival |
12. Alzheimer’s disease: clinicaltrials.gov NCT00951834 Estimated enrollment: 50 Estimated completion: June 2015 (final data collection date for primary outcome measure) |
Green tea compound epigallocatechin-3-galleteEfficacy studyPhase 2/3:randomized, double-blind study of efficacy | RecruitingPrimary outcome measures:ADAS-COG (score 0–70)Secondary outcome measures:safety and tolerability, MMSE score after 18 months vs. baseline, time to hospitalization and time to death related to AD, brain atrophy via MRI, baseline ADAS-COG and baseline-MMSE as covariates, CIBIC+ and WHO QoL Bref, trail making test, and MVGT |
13. Primary (cardiac) amyloidosis of light chain type: clinicaltrials.gov NCT01511263 Estimated enrollment: 86 Estimated completion: December 2015 (final data collection date for primary outcome measure) |
Green tea compound epigallocatechin-3-gallete Efficacy Phase 2: open-label, randomized study of dietary EGCG |
Recruiting Primary outcome measures:cardiac response (rate of cardiac response following chemotherapy in patients with AL amyloidosis); endpoint at 6 months Secondary outcome measures:rate of adverse events, cardiac progression, time to cardiac progression, rate of cardiac events, time to cardiac events, survival at 6 months |
EGCG, epigallocatechin-3-gallete.
Created from data available at: clinicaltrials.gov (accessed 2 February, 2015).