Safety,tolerability and PK MAD of ALZ-801 in Elderly Volunteers 117609
Research type
Research Study
Full title
A Phase I, Single Centre, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability and Pharmacokinetics in Plasma and Urine of Multiple Ascending Doses of ALZ-801 in Healthy Elderly Subjects.
IRAS ID
187407
Contact name
Susan Ward
Contact email
Sponsor organisation
Alzheon Inc.
Eudract number
2015-002954-11
Duration of Study in the UK
0 years, 3 months, 0 days
Research summary
The Sponsor is developing the study drug, ALZ-801, for the potential treatment of Alzheimer’s disease. Alzheimer’s disease (AD) is an irreversible, progressive disorder leading to the loss of nerve function and structure, characterised by gradual decline in mental function, abnormal behaviour and personality changes.\n\nThe study will try to determine how different doses of ALZ-801 given daily for 14 days are taken up by the body.\n\nThe study will consist of 3 cohorts. Each cohort will be made up of 12 subjects aged 50-75 inclusive and will be randomized in a 3:1 ratio to receive ALZ-801 (9) or placebo (3) for 2 weeks. \n\nSubjects in cohort A will receive 171mg of ALZ-801 or matching placebo once on day 1. Day’s 2 to 7 subjects will receive 171mg of ALZ-801 or matching placebo twice daily. Days 8 to 14 subjects will receive 256.5mg of ALZ-801 or matching placebo once daily.\n\nSubjects in cohort B will receive 256.5mg of ALZ-801 or matching placebo once on day 1. Day’s 2 to 7 subjects will receive 256.5mg of ALZ-801 or matching placebo twice daily. Days 8 to 14 subjects will receive 340mg of ALZ-801 or matching placebo once daily.\n\nSubjects in cohort C will receive 256.5mg of ALZ-801 or matching placebo once on day 1. Day’s 2 to 7 subjects will receive 256.5mg of ALZ-801 or matching placebo twice daily. Days 8 to 14 subjects will receive 513mg of ALZ-801 or matching placebo once daily.\n
REC name
Wales REC 2
REC reference
15/WA/0274
Date of REC Opinion
28 Aug 2015
REC opinion
Further Information Favourable Opinion