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. 2015 May 19;2:25. doi: 10.3389/fcvm.2015.00025

Table 3.

Clinical studies investigating ECGG in primary cardiac amyloidosis and Alzheimer’s disease.

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).