AZD-103/ELND005 Phasell Dosing revealed.....
Dosing Rates now available on clinicaltrials.gov.
Dosing patients from 1/2 gram per day in one arm. 2 grams/day in second arm. 4 grams/day in third arm.
Interesting to note ----- The lowest dose coincides with the Preclinical dosing. Phasel Trials were dosed up into the multiple grams/day range safely
---Preclinical research showed that ELND005 twice-daily (BID) dosing of Transgenic AD Mice was more effective than once-daily dosing at reversing cognitive deficits. [ Fenili, D et al, J of Molecular Medicine. Feb.6/07 ]
---Preclinical Data, a 3.3 mg/kg dose produced a significant effect on reducing plaque count and soluble beta-Amyloid Oligomers. ( The 3.3 mg/kg dose equates to giving a 70kg. Human a 230mg dose.) [Sept.6/07 RBC Analyst]
Note thePhasell dosing is starting at 250mg.BID. Highest dosing arm is 2000 mg.BID. Four grams per day is over 8 times as much dosed in the Preclinical 3.3mg/kg mentioned above assuming twice daily admin.
https://www.clinicaltrials.gov/ct2/show/NCT00568776?term=elnd-005&rank=1
ELND 005
Estimated Enrollment: 340
Study Start Date: December 2007
Arms Assigned Interventions
1: Active Comparator Drug: ELND005
250mg BID [total daily dose (TDD) = 500mg]administered orally.
2: Active Comparator Drug: ELND005
1000mg BID [total daily dose (TDD) = 2000mg] administered orally.
3: Active Comparator Drug: ELND005
2000mg BID [total daily dose (TDD) = 4000mg]administered orally.
4: Placebo Comparator Drug: Placebo Control
Placebo control administered to patients.